Trial Outcomes & Findings for Early Percutaneous Cryoablation for Pain Control After Rib Fractures Among Elderly Patients (NCT NCT04482582)
NCT ID: NCT04482582
Last Updated: 2026-03-27
Results Overview
The patient will be asked to verbalize their numeric pain score on the day of hospital discharge. Pain is measured on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain. Note: The timing of hospital discharge varies by patient as these are polytrauma patients.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
127 participants
Primary outcome timeframe
Hospital discharge (up to 1 month)
Results posted on
2026-03-27
Participant Flow
Patients were pre-screened to determine if they met eligibility criteria. If this was met, they were approached by a CRC for in-person consent at Stanford Healthcare (SHC). The enrollment period was from June 1, 2021, to April 15, 2024.
Participant milestones
| Measure |
Image-guided Percutaneous ICN (pICN): Group A
Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to percutaneous image-guided cryoneurolysis (pICN) group within 72 hours of presentation.
|
Standard-of Care : Group B
Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to standard-of-care group within 72 hours of presentation.
|
|---|---|---|
|
Baseline
STARTED
|
72
|
55
|
|
Baseline
COMPLETED
|
49
|
54
|
|
Baseline
NOT COMPLETED
|
23
|
1
|
|
1-month follow-up
STARTED
|
56
|
54
|
|
1-month follow-up
COMPLETED
|
39
|
38
|
|
1-month follow-up
NOT COMPLETED
|
17
|
16
|
|
3-month follow-up
STARTED
|
56
|
49
|
|
3-month follow-up
COMPLETED
|
35
|
37
|
|
3-month follow-up
NOT COMPLETED
|
21
|
12
|
|
12-month follow-up
STARTED
|
53
|
47
|
|
12-month follow-up
COMPLETED
|
30
|
32
|
|
12-month follow-up
NOT COMPLETED
|
23
|
15
|
Reasons for withdrawal
| Measure |
Image-guided Percutaneous ICN (pICN): Group A
Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to percutaneous image-guided cryoneurolysis (pICN) group within 72 hours of presentation.
|
Standard-of Care : Group B
Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to standard-of-care group within 72 hours of presentation.
|
|---|---|---|
|
Baseline
Screen failure
|
20
|
0
|
|
Baseline
Withdrawal by Subject
|
2
|
0
|
|
Baseline
Dropped by Investigator
|
1
|
0
|
|
Baseline
Protocol Violation
|
0
|
1
|
|
1-month follow-up
Lost to Follow-up
|
17
|
11
|
|
1-month follow-up
Withdrawal by Subject
|
0
|
5
|
|
3-month follow-up
Lost to Follow-up
|
18
|
10
|
|
3-month follow-up
Death
|
1
|
0
|
|
3-month follow-up
Withdrawal by Subject
|
2
|
2
|
|
12-month follow-up
Lost to Follow-up
|
21
|
12
|
|
12-month follow-up
Death
|
2
|
3
|
Baseline Characteristics
Early Percutaneous Cryoablation for Pain Control After Rib Fractures Among Elderly Patients
Baseline characteristics by cohort
| Measure |
Image-guided Percutaneous ICN (pICN): Group A
n=56 Participants
Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to percutaneous image-guided cryoneurolysis (pICN) group within 72 hours of presentation.
|
Standard-of Care : Group B
n=54 Participants
Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to standard-of-care group within 72 hours of presentation.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
76 years
n=56 Participants
|
81 years
n=62 Participants
|
79.5 years
n=123 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=56 Participants
|
31 Participants
n=62 Participants
|
59 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=56 Participants
|
23 Participants
n=62 Participants
|
51 Participants
n=123 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
6 Participants
n=56 Participants
|
6 Participants
n=62 Participants
|
12 Participants
n=123 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Pacific Islander
|
0 Participants
n=56 Participants
|
1 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
|
Race/Ethnicity, Customized
Race · Black of African American
|
1 Participants
n=56 Participants
|
1 Participants
n=62 Participants
|
2 Participants
n=123 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
42 Participants
n=56 Participants
|
41 Participants
n=62 Participants
|
83 Participants
n=123 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown or not reported
|
7 Participants
n=56 Participants
|
5 Participants
n=62 Participants
|
12 Participants
n=123 Participants
|
|
Highest pain score in first 24 hours
|
8.11 points
STANDARD_DEVIATION 1.55 • n=56 Participants
|
8.04 points
STANDARD_DEVIATION 1.64 • n=62 Participants
|
8.07 points
STANDARD_DEVIATION 1.58 • n=123 Participants
|
|
Daily opioid equivalents in first 24 hours
|
24.75 MMEs
n=56 Participants
|
25 MMEs
n=62 Participants
|
25 MMEs
n=123 Participants
|
PRIMARY outcome
Timeframe: Hospital discharge (up to 1 month)Population: Includes 7 ITT patients per September 2023 protocol amendment
The patient will be asked to verbalize their numeric pain score on the day of hospital discharge. Pain is measured on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain. Note: The timing of hospital discharge varies by patient as these are polytrauma patients.
Outcome measures
| Measure |
Image-guided Percutaneous ICN (pICN): Group A
n=56 Participants
Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to percutaneous image-guided cryoneurolysis (pICN) group within 72 hours of presentation.
|
Standard-of Care : Group B
n=54 Participants
Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to standard-of-care group within 72 hours of presentation.
|
|---|---|---|
|
Acute Pain Assessed by Numeric Pain Score
|
5.61 score on a scale
Standard Deviation 2.42
|
5.93 score on a scale
Standard Deviation 2.44
|
SECONDARY outcome
Timeframe: 1 month after hospital dischargePopulation: This analysis population includes patients with available data.
Will be obtained from chart review after discharge
Outcome measures
| Measure |
Image-guided Percutaneous ICN (pICN): Group A
n=55 Participants
Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to percutaneous image-guided cryoneurolysis (pICN) group within 72 hours of presentation.
|
Standard-of Care : Group B
n=49 Participants
Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to standard-of-care group within 72 hours of presentation.
|
|---|---|---|
|
30-day Mortality
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 month after hospital dischargePopulation: Includes 7 ITT patients
Will be obtained from chart review after discharge
Outcome measures
| Measure |
Image-guided Percutaneous ICN (pICN): Group A
n=56 Participants
Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to percutaneous image-guided cryoneurolysis (pICN) group within 72 hours of presentation.
|
Standard-of Care : Group B
n=54 Participants
Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to standard-of-care group within 72 hours of presentation.
|
|---|---|---|
|
Number of Participants Requiring ICU Admission
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 1 monthPopulation: Includes 7 ITT patients
The Length of Stay will be obtained from the patient's chart after discharge and will depend on the level of care required for recovery from their injuries.
Outcome measures
| Measure |
Image-guided Percutaneous ICN (pICN): Group A
n=56 Participants
Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to percutaneous image-guided cryoneurolysis (pICN) group within 72 hours of presentation.
|
Standard-of Care : Group B
n=54 Participants
Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to standard-of-care group within 72 hours of presentation.
|
|---|---|---|
|
Length of Hospital Stay
|
4 days
Interval 3.0 to 7.0
|
5.5 days
Interval 3.0 to 7.0
|
SECONDARY outcome
Timeframe: Hospital discharge (up to 1 month), 1 month, 3 months, 12 months after hospital dischargePopulation: Includes 7 ITT patients
Daily oral narcotic equivalents
Outcome measures
| Measure |
Image-guided Percutaneous ICN (pICN): Group A
n=56 Participants
Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to percutaneous image-guided cryoneurolysis (pICN) group within 72 hours of presentation.
|
Standard-of Care : Group B
n=54 Participants
Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to standard-of-care group within 72 hours of presentation.
|
|---|---|---|
|
Use of Narcotic Equivalents
Discharge
|
24.11 MME/day
Interval 5.63 to 45.0
|
15.00 MME/day
Interval 3.75 to 33.75
|
|
Use of Narcotic Equivalents
1-month follow-up
|
0 MME/day
Interval 0.0 to 4.7
|
0 MME/day
Interval 0.0 to 0.0
|
|
Use of Narcotic Equivalents
3-month follow-up
|
0 MME/day
Interval 0.0 to 0.0
|
0 MME/day
Interval 0.0 to 0.0
|
|
Use of Narcotic Equivalents
12-month follow-up
|
0 MME/day
Interval 0.0 to 0.0
|
0 MME/day
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 1 month after hospital dischargePopulation: Participants with available data were included in this analysis.
The patient will be admitted back to the hospital if pain level relates to rib-specific injuries such as hemothorax and pneumonia.
Outcome measures
| Measure |
Image-guided Percutaneous ICN (pICN): Group A
n=55 Participants
Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to percutaneous image-guided cryoneurolysis (pICN) group within 72 hours of presentation.
|
Standard-of Care : Group B
n=49 Participants
Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to standard-of-care group within 72 hours of presentation.
|
|---|---|---|
|
Number of Participants With a Rib-specific Readmission Within 30 Days of Discharge
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 month, 3 months, 12 months (all from hospital discharge)Population: The analysis population includes everyone who has at least 1 McGill score reported at any follow-up timepoint.
The McGill Pain Questionnaire (MPQ) is a validated 20 question instrument to quantify subjective pain and the scoring system yields a Pain Rating Index (PRI) score between Mild, Moderate or Severe. The questionnaire will be administered to the patient by study/ clinical staff at 1-month, 3-month, and 12-month follow-ups. Using the questionnaires, McGill Present Pain Intensity (PPI), Sensory, Affective, and Visual Analogue Scale scores will be calculated and reported. PPI and Visual Analogue Scale scores are on a scale of 0-10, Sensory scores are on a scale of 0-33, and Affective scores are on a scale of 0-12. Higher scores indicate worse pain for all McGill scores.
Outcome measures
| Measure |
Image-guided Percutaneous ICN (pICN): Group A
n=48 Participants
Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to percutaneous image-guided cryoneurolysis (pICN) group within 72 hours of presentation.
|
Standard-of Care : Group B
n=48 Participants
Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to standard-of-care group within 72 hours of presentation.
|
|---|---|---|
|
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score
PPI at 1-month follow-up (0-10)
|
2.72 scores on a scale
Standard Deviation 2.35
|
1.73 scores on a scale
Standard Deviation 1.76
|
|
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score
Sensory at 1-month follow-up (0-33)
|
4.64 scores on a scale
Standard Deviation 4.89
|
1.50 scores on a scale
Standard Deviation 2.01
|
|
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score
Affective at 1-month follow-up
|
1.15 scores on a scale
Standard Deviation 1.48
|
0.41 scores on a scale
Standard Deviation 0.89
|
|
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score
Visual Analogue Scale at 1-month follow-up
|
—
|
0 scores on a scale
Standard Deviation 0
|
|
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score
PPI at 3-month follow-up
|
1.42 scores on a scale
Standard Deviation 1.75
|
0.89 scores on a scale
Standard Deviation 1.30
|
|
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score
Sensory at 3-month follow-up
|
1.00 scores on a scale
Standard Deviation 1.44
|
0.63 scores on a scale
Standard Deviation 1.55
|
|
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score
Affective at 3-month follow-up
|
0.12 scores on a scale
Standard Deviation 0.42
|
0.12 scores on a scale
Standard Deviation 0.48
|
|
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score
Visual Analogue Scale at 3-month follow-up
|
1 scores on a scale
|
0.50 scores on a scale
Standard Deviation 0.71
|
|
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score
PPI at 12-month follow-up
|
0.60 scores on a scale
Standard Deviation 1.10
|
0.55 scores on a scale
Standard Deviation 1.26
|
|
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score
Sensory at 12-month follow-up
|
0.37 scores on a scale
Standard Deviation 0.72
|
0.29 scores on a scale
Standard Deviation 0.74
|
|
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score
Affective at 12-month follow-up
|
0 scores on a scale
Standard Deviation 0
|
0 scores on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 1 month, 3 months, 12 months (all from hospital discharge)Population: Participants who had GOS-E data at any follow-up time point are included.
The Glasgow Outcome Scale (GOS) is a global scale for functional outcome that rates patient status into one of five categories: Dead, Vegetative State, Severe Disability, Moderate Disability or Good Recovery. The Extended GOS (GOSE) provides more detailed categorization into eight categories by subdividing the categories of severe disability, moderate disability and good recovery into a lower and upper category: 1. Death (D) 2. Vegetative state (VS) 3. Lower severe disability (SD -) 4. Upper severe disability (SD +) 5. Lower moderate disability ( MD -) 6. Upper moderate disability ( MD +) 7. Lower good recovery (GR -) 8. Upper good recovery (GR +) The questionnaire will be administered to the patient by study/clinical staff upon discharge.
Outcome measures
| Measure |
Image-guided Percutaneous ICN (pICN): Group A
n=48 Participants
Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to percutaneous image-guided cryoneurolysis (pICN) group within 72 hours of presentation.
|
Standard-of Care : Group B
n=47 Participants
Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to standard-of-care group within 72 hours of presentation.
|
|---|---|---|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
1-month follow-up · SD-
|
2 Participants
|
0 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
1-month follow-up · SD+
|
13 Participants
|
17 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
1-month follow-up · MD-
|
3 Participants
|
1 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
1-month follow-up · MD+
|
6 Participants
|
5 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
1-month follow-up · GR-
|
6 Participants
|
6 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
1-month follow-up · GR+
|
9 Participants
|
8 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
3-month follow-up · SD-
|
0 Participants
|
0 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
3-month follow-up · SD+
|
3 Participants
|
9 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
3-month follow-up · MD-
|
0 Participants
|
2 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
3-month follow-up · MD+
|
4 Participants
|
2 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
3-month follow-up · GR-
|
9 Participants
|
3 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
3-month follow-up · GR+
|
18 Participants
|
19 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
12-month follow-up · SD-
|
0 Participants
|
0 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
12-month follow-up · SD+
|
5 Participants
|
3 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
12-month follow-up · MD-
|
0 Participants
|
0 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
12-month follow-up · MD+
|
1 Participants
|
4 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
12-month follow-up · GR-
|
4 Participants
|
6 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
12-month follow-up · GR+
|
20 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 1 month, 3 months, 12 months (all from hospital discharge)Population: Participants with available SF-12 scores at any follow-up time point were included.
The 12-Item Short-Form Health Survey is a widely used composite score used to gauge overall health. The composite score is based on 8 domains scores contained in the SF-12 questionnaire, which will be administered to the patient by study/clinical staff upon discharge. The composite score is split into two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Both scores are on a scale of 0-100, with higher scores representing better mental health-related (MCS) or physical health-related (PCS) quality of life. The means of both scores are standardized to 50 with a standard devation of 10.
Outcome measures
| Measure |
Image-guided Percutaneous ICN (pICN): Group A
n=48 Participants
Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to percutaneous image-guided cryoneurolysis (pICN) group within 72 hours of presentation.
|
Standard-of Care : Group B
n=46 Participants
Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to standard-of-care group within 72 hours of presentation.
|
|---|---|---|
|
Short Form (SF-12) Health Survey Scale Score
SF-12 PCS at 1-month follow-up
|
32.93 score on a scale
Interval 25.18 to 41.52
|
29.89 score on a scale
Interval 24.16 to 43.68
|
|
Short Form (SF-12) Health Survey Scale Score
SF-12 MCS score at 1-month follow-up
|
55.14 score on a scale
Interval 49.7 to 58.14
|
55.65 score on a scale
Interval 46.08 to 60.13
|
|
Short Form (SF-12) Health Survey Scale Score
SF-12 PCS at 3-month follow-up
|
51.38 score on a scale
Interval 43.0 to 53.55
|
47.96 score on a scale
Interval 29.86 to 55.5
|
|
Short Form (SF-12) Health Survey Scale Score
SF-12 MCS score at 3-month follow-up
|
58.73 score on a scale
Interval 53.1 to 60.76
|
57.83 score on a scale
Interval 49.37 to 60.29
|
|
Short Form (SF-12) Health Survey Scale Score
SF-12 PCS at 12-month follow-up
|
52.77 score on a scale
Interval 47.94 to 55.5
|
51.46 score on a scale
Interval 44.83 to 55.48
|
|
Short Form (SF-12) Health Survey Scale Score
SF-12 MCS at 12-month follow-up
|
57.83 score on a scale
Interval 53.2 to 60.7
|
59.65 score on a scale
Interval 55.87 to 61.6
|
Adverse Events
Image-guided Percutaneous ICN (pICN): Group A
Serious events: 13 serious events
Other events: 9 other events
Deaths: 3 deaths
Standard-of Care : Group B
Serious events: 11 serious events
Other events: 24 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Image-guided Percutaneous ICN (pICN): Group A
n=56 participants at risk
Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to percutaneous image-guided cryoneurolysis (pICN) group within 72 hours of presentation.
|
Standard-of Care : Group B
n=54 participants at risk
Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to standard-of-care group within 72 hours of presentation.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Rib specific readmission
|
0.00%
0/56 • From enrollment to one year post-discharge from hospital
Prospective and retrospective analysis
|
1.9%
1/54 • Number of events 1 • From enrollment to one year post-discharge from hospital
Prospective and retrospective analysis
|
|
General disorders
Non chest wall related readmission
|
23.2%
13/56 • From enrollment to one year post-discharge from hospital
Prospective and retrospective analysis
|
18.5%
10/54 • From enrollment to one year post-discharge from hospital
Prospective and retrospective analysis
|
Other adverse events
| Measure |
Image-guided Percutaneous ICN (pICN): Group A
n=56 participants at risk
Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to percutaneous image-guided cryoneurolysis (pICN) group within 72 hours of presentation.
|
Standard-of Care : Group B
n=54 participants at risk
Patients who were admitted after a traumatic injury, with rib fractures identified, who are \>= 65 years of age will be randomized to standard-of-care group within 72 hours of presentation.
|
|---|---|---|
|
Nervous system disorders
Composite mild neurological events
|
1.8%
1/56 • From enrollment to one year post-discharge from hospital
Prospective and retrospective analysis
|
3.7%
2/54 • From enrollment to one year post-discharge from hospital
Prospective and retrospective analysis
|
|
Respiratory, thoracic and mediastinal disorders
Hematoma
|
1.8%
1/56 • From enrollment to one year post-discharge from hospital
Prospective and retrospective analysis
|
0.00%
0/54 • From enrollment to one year post-discharge from hospital
Prospective and retrospective analysis
|
|
Respiratory, thoracic and mediastinal disorders
hemopneumothorax
|
3.6%
2/56 • From enrollment to one year post-discharge from hospital
Prospective and retrospective analysis
|
1.9%
1/54 • From enrollment to one year post-discharge from hospital
Prospective and retrospective analysis
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary contusion
|
1.8%
1/56 • From enrollment to one year post-discharge from hospital
Prospective and retrospective analysis
|
0.00%
0/54 • From enrollment to one year post-discharge from hospital
Prospective and retrospective analysis
|
|
Cardiac disorders
bradycardia/tachycardia/atrial fibrillation/hypotension/code blue/aortic stenosis
|
7.1%
4/56 • From enrollment to one year post-discharge from hospital
Prospective and retrospective analysis
|
18.5%
10/54 • From enrollment to one year post-discharge from hospital
Prospective and retrospective analysis
|
|
Infections and infestations
Infection
|
0.00%
0/56 • From enrollment to one year post-discharge from hospital
Prospective and retrospective analysis
|
3.7%
2/54 • From enrollment to one year post-discharge from hospital
Prospective and retrospective analysis
|
|
Gastrointestinal disorders
Constipation/vomiting
|
0.00%
0/56 • From enrollment to one year post-discharge from hospital
Prospective and retrospective analysis
|
16.7%
9/54 • From enrollment to one year post-discharge from hospital
Prospective and retrospective analysis
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place