Trial Outcomes & Findings for Contract-Relax (CR) Technique in the Management of Diaphragmatic Paresis After Cardiac Surgery (NCT NCT05068219)
NCT ID: NCT05068219
Last Updated: 2026-06-08
Results Overview
Diaphragmatic excursion ratio during maximum inspiration, assessed separately for the left and right hemidiaphragms by ultrasound in TM mode. Measurements were obtained at Day 3 before the first rehabilitation session of the day (M1max, diaphragmatic displacement in mm) and at Day 5 before the first rehabilitation session of the day (M2max, diaphragmatic displacement in mm). The reported values correspond to the ratio of diaphragmatic excursion at Day 5 relative to Day 3 (M2max/M1max).
COMPLETED
NA
27 participants
Days 3 and 5
2026-06-08
Participant Flow
Participant milestones
| Measure |
Usual Technique
Standard rehabilitation
|
CR Technique
Standard rehabilitation + 3 CR
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
|
Overall Study
COMPLETED
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Usual Technique
n=14 Participants
Standard rehabilitation
|
CR Technique
n=13 Participants
Standard rehabilitation + 3 CR
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71 years
n=14 Participants
|
66 years
n=13 Participants
|
70 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=14 Participants
|
3 Participants
n=13 Participants
|
5 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=14 Participants
|
10 Participants
n=13 Participants
|
22 Participants
n=27 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Laterality of diaphragmatic paresis
Right-sided
|
4 Participants
n=14 Participants
|
6 Participants
n=13 Participants
|
10 Participants
n=27 Participants
|
|
Laterality of diaphragmatic paresis
Left-sided
|
3 Participants
n=14 Participants
|
1 Participants
n=13 Participants
|
4 Participants
n=27 Participants
|
|
Laterality of diaphragmatic paresis
Bilateral
|
7 Participants
n=14 Participants
|
6 Participants
n=13 Participants
|
13 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Days 3 and 5Population: The analysis was performed separately for the left and right sides, and not all patients had bilateral diaphragmatic paresis.
Diaphragmatic excursion ratio during maximum inspiration, assessed separately for the left and right hemidiaphragms by ultrasound in TM mode. Measurements were obtained at Day 3 before the first rehabilitation session of the day (M1max, diaphragmatic displacement in mm) and at Day 5 before the first rehabilitation session of the day (M2max, diaphragmatic displacement in mm). The reported values correspond to the ratio of diaphragmatic excursion at Day 5 relative to Day 3 (M2max/M1max).
Outcome measures
| Measure |
Usual Technique
n=14 Participants
Standard rehabilitation
|
CR Technique
n=13 Participants
Standard rehabilitation + 3 CR
|
|---|---|---|
|
Diaphragmatic Excursion in Maximum Inspiration
Right-sided diaphragmatic excursion ratio
|
1.64 ratio
Interval 1.42 to 2.01
|
1.88 ratio
Interval 1.82 to 2.75
|
|
Diaphragmatic Excursion in Maximum Inspiration
Left-sided diaphragmatic excursion ratio
|
1.75 ratio
Interval 1.36 to 2.11
|
1.46 ratio
Interval 0.95 to 2.2
|
SECONDARY outcome
Timeframe: Days 3 and 5Population: The analysis was performed separately for the left and right sides, and not all patients had bilateral diaphragmatic paresis.
Diaphragmatic excursion ratio during normal inspiration, assessed separately for the left and right hemidiaphragms by ultrasound in TM mode. Measurements were obtained at Day 3 before the first rehabilitation session of the day (M1rest, diaphragmatic displacement in mm) and at Day 5 before the first rehabilitation session of the day (M2rest, diaphragmatic displacement in mm). The reported values correspond to the ratio of diaphragmatic excursion at Day 5 relative to Day 3 (M2rest/M1rest).
Outcome measures
| Measure |
Usual Technique
n=14 Participants
Standard rehabilitation
|
CR Technique
n=13 Participants
Standard rehabilitation + 3 CR
|
|---|---|---|
|
Diaphragmatic Excursion in Normal Inspiration
Right-sided diaphragmatic excursion ratio
|
1.22 ratio
Interval 1.0 to 1.69
|
1.42 ratio
Interval 1.19 to 1.86
|
|
Diaphragmatic Excursion in Normal Inspiration
Left-sided diaphragmatic excursion ratio
|
1.36 ratio
Interval 1.07 to 1.91
|
1.11 ratio
Interval 0.83 to 1.63
|
SECONDARY outcome
Timeframe: Days 3, 4 and 5SpO2 (%) before and after each physiotherapy session on D3 and D4 and before the first rehabilitation session of the day on D5.
Outcome measures
| Measure |
Usual Technique
n=14 Participants
Standard rehabilitation
|
CR Technique
n=13 Participants
Standard rehabilitation + 3 CR
|
|---|---|---|
|
Oxygen Saturation
SpO2 Day3 - Before physiotherapy session 4
|
95.5 Percentage of oxygenated hemoglobin
Interval 94.0 to 97.0
|
96.0 Percentage of oxygenated hemoglobin
Interval 94.0 to 96.0
|
|
Oxygen Saturation
SpO2 Day3 - After physiotherapy session 4
|
96.0 Percentage of oxygenated hemoglobin
Interval 94.7 to 97.2
|
97.0 Percentage of oxygenated hemoglobin
Interval 96.0 to 98.0
|
|
Oxygen Saturation
SpO2 Day4 - Before physiotherapy session 1
|
96.0 Percentage of oxygenated hemoglobin
Interval 94.0 to 98.0
|
94.0 Percentage of oxygenated hemoglobin
Interval 92.0 to 95.0
|
|
Oxygen Saturation
SpO2 Day4 - After physiotherapy session 1
|
95.0 Percentage of oxygenated hemoglobin
Interval 95.0 to 96.0
|
95.0 Percentage of oxygenated hemoglobin
Interval 95.0 to 96.0
|
|
Oxygen Saturation
SpO2 Day4 - Before physiotherapy session 2
|
95.0 Percentage of oxygenated hemoglobin
Interval 94.0 to 97.0
|
93.0 Percentage of oxygenated hemoglobin
Interval 93.0 to 95.5
|
|
Oxygen Saturation
SpO2 Day4 - After physiotherapy session 2
|
96.0 Percentage of oxygenated hemoglobin
Interval 95.0 to 96.0
|
96.0 Percentage of oxygenated hemoglobin
Interval 95.2 to 97.7
|
|
Oxygen Saturation
SpO2 Day4 - Before physiotherapy session 3
|
95.0 Percentage of oxygenated hemoglobin
Interval 94.0 to 96.0
|
94.5 Percentage of oxygenated hemoglobin
Interval 93.2 to 96.0
|
|
Oxygen Saturation
SpO2 Day4 - After physiotherapy session 3
|
96.0 Percentage of oxygenated hemoglobin
Interval 95.0 to 98.0
|
97.0 Percentage of oxygenated hemoglobin
Interval 95.2 to 98.0
|
|
Oxygen Saturation
SpO2 Day4 - Before physiotherapy session 4
|
96.0 Percentage of oxygenated hemoglobin
Interval 94.7 to 96.2
|
95.5 Percentage of oxygenated hemoglobin
Interval 94.0 to 96.0
|
|
Oxygen Saturation
SpO2 Day4 - After physiotherapy session 4
|
96.0 Percentage of oxygenated hemoglobin
Interval 95.0 to 98.0
|
96.5 Percentage of oxygenated hemoglobin
Interval 95.0 to 97.7
|
|
Oxygen Saturation
SpO2 Day5
|
95.0 Percentage of oxygenated hemoglobin
Interval 94.0 to 97.0
|
96.0 Percentage of oxygenated hemoglobin
Interval 94.0 to 97.0
|
|
Oxygen Saturation
SpO2 Day3 - Before physiotherapy session 1
|
96.0 Percentage of oxygenated hemoglobin
Interval 93.0 to 97.0
|
96.0 Percentage of oxygenated hemoglobin
Interval 93.5 to 96.5
|
|
Oxygen Saturation
SpO2 Day3 - After physiotherapy session 1
|
95.0 Percentage of oxygenated hemoglobin
Interval 94.0 to 96.0
|
95.0 Percentage of oxygenated hemoglobin
Interval 93.5 to 98.0
|
|
Oxygen Saturation
SpO2 Day3 - Before physiotherapy session 2
|
95.0 Percentage of oxygenated hemoglobin
Interval 93.7 to 95.5
|
96.0 Percentage of oxygenated hemoglobin
Interval 94.0 to 97.5
|
|
Oxygen Saturation
SpO2 Day3 - After physiotherapy session 2
|
95.0 Percentage of oxygenated hemoglobin
Interval 94.0 to 96.0
|
97.0 Percentage of oxygenated hemoglobin
Interval 93.5 to 99.0
|
|
Oxygen Saturation
SpO2 Day3 - Before physiotherapy session 3
|
95.0 Percentage of oxygenated hemoglobin
Interval 94.0 to 98.0
|
96.0 Percentage of oxygenated hemoglobin
Interval 95.0 to 97.0
|
|
Oxygen Saturation
SpO2 Day3 - After physiotherapy session 3
|
96.0 Percentage of oxygenated hemoglobin
Interval 94.0 to 98.0
|
97.0 Percentage of oxygenated hemoglobin
Interval 95.7 to 98.2
|
SECONDARY outcome
Timeframe: from Baseline (Day 0) through Day 30Population: Patients requiring noninvasive ventilation.
Duration of non-invasive ventilation : NIV, optiflow, CPAP (hours).
Outcome measures
| Measure |
Usual Technique
n=5 Participants
Standard rehabilitation
|
CR Technique
n=7 Participants
Standard rehabilitation + 3 CR
|
|---|---|---|
|
Non-invasive Ventilation
|
4.0 hours
Interval 3.7 to 11.0
|
32.9 hours
Interval 23.5 to 36.2
|
SECONDARY outcome
Timeframe: from Baseline (Day 0) through Day 30Time of oxygen therapy weaning (days). The reference time t0 will be the time of postoperative extubation.
Outcome measures
| Measure |
Usual Technique
n=14 Participants
Standard rehabilitation
|
CR Technique
n=13 Participants
Standard rehabilitation + 3 CR
|
|---|---|---|
|
Oxygenation
|
3.68 days
Interval 3.36 to 5.61
|
4.83 days
Interval 3.26 to 5.53
|
SECONDARY outcome
Timeframe: from Baseline (Day 0) through Day 30Occurence of reintubation, lung disease, atelectasis, bronchial fibroscopy, bronchospasm, pleural effusion, pneumothorax.
Outcome measures
| Measure |
Usual Technique
n=14 Participants
Standard rehabilitation
|
CR Technique
n=13 Participants
Standard rehabilitation + 3 CR
|
|---|---|---|
|
Incidence of Respiratory Complications
Reintubation
|
0 Participants
|
1 Participants
|
|
Incidence of Respiratory Complications
Lung disease
|
2 Participants
|
2 Participants
|
|
Incidence of Respiratory Complications
Atelectasis
|
7 Participants
|
9 Participants
|
|
Incidence of Respiratory Complications
Bronchial fibroscopy
|
0 Participants
|
0 Participants
|
|
Incidence of Respiratory Complications
Bronchospasm
|
0 Participants
|
0 Participants
|
|
Incidence of Respiratory Complications
Pleural effusion
|
1 Participants
|
1 Participants
|
|
Incidence of Respiratory Complications
Pneumothorax
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: from Baseline (Day 0) through Day 30Duration of ICU stay (days).
Outcome measures
| Measure |
Usual Technique
n=14 Participants
Standard rehabilitation
|
CR Technique
n=13 Participants
Standard rehabilitation + 3 CR
|
|---|---|---|
|
Intensive Care Unit ICU Length of Stay
|
4 days
Interval 3.0 to 7.0
|
4 days
Interval 3.0 to 8.0
|
SECONDARY outcome
Timeframe: from Baseline (Day 0) through Day 30Duration of hospitalization (days).
Outcome measures
| Measure |
Usual Technique
n=14 Participants
Standard rehabilitation
|
CR Technique
n=13 Participants
Standard rehabilitation + 3 CR
|
|---|---|---|
|
Hospital Length of Stay
|
9 days
Interval 8.0 to 11.0
|
8 days
Interval 8.0 to 14.0
|
SECONDARY outcome
Timeframe: Days 3 and 4Self-assessment by the patient of the pain felt with a Numeric Rating Scale (NRS) from 0 (No pain) to 10 (Worst Possible Pain) after each session of respiratory physiotherapy at D3 and D4.
Outcome measures
| Measure |
Usual Technique
n=13 Participants
Standard rehabilitation
|
CR Technique
n=12 Participants
Standard rehabilitation + 3 CR
|
|---|---|---|
|
Pain Score : Numeric Rating Scale (NRS)
NRS Day3 - physiotherapy session 1
|
4 Score on a scale
Interval 2.0 to 4.0
|
4 Score on a scale
Interval 3.0 to 5.0
|
|
Pain Score : Numeric Rating Scale (NRS)
NRS Day3 - physiotherapy session 2
|
3 Score on a scale
Interval 2.0 to 4.0
|
3 Score on a scale
Interval 2.0 to 4.0
|
|
Pain Score : Numeric Rating Scale (NRS)
NRS Day3 - physiotherapy session 3
|
3 Score on a scale
Interval 2.0 to 4.0
|
3 Score on a scale
Interval 2.0 to 4.0
|
|
Pain Score : Numeric Rating Scale (NRS)
NRS Day3 - physiotherapy session 4
|
2 Score on a scale
Interval 2.0 to 3.0
|
3 Score on a scale
Interval 2.0 to 4.0
|
|
Pain Score : Numeric Rating Scale (NRS)
NRS Day4 - physiotherapy session 1
|
2 Score on a scale
Interval 1.0 to 3.0
|
2 Score on a scale
Interval 1.0 to 3.0
|
|
Pain Score : Numeric Rating Scale (NRS)
NRS Day4 - physiotherapy session 2
|
2 Score on a scale
Interval 1.0 to 2.0
|
2 Score on a scale
Interval 0.0 to 3.0
|
|
Pain Score : Numeric Rating Scale (NRS)
NRS Day4 - physiotherapy session 3
|
2 Score on a scale
Interval 0.0 to 3.0
|
2 Score on a scale
Interval 0.0 to 3.0
|
|
Pain Score : Numeric Rating Scale (NRS)
NRS Day4 - physiotherapy session 4
|
2 Score on a scale
Interval 1.0 to 3.0
|
1 Score on a scale
Interval 0.0 to 2.0
|
Adverse Events
Usual Technique
CR Technique
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place