Trial Outcomes & Findings for Tracheal Palpation of Sliding Cuff to Assess Endotracheal Tube Location (NCT NCT02502461)
NCT ID: NCT02502461
Last Updated: 2019-03-06
Results Overview
Surrogate measure of tissue damage from moving the tube with cuff inflated = soreness of throat on an 11-point verbal pain scale, with 0 = no pain, and 10 the worst pain imaginable.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
when patient awake (within 24 hours of intubation)
Results posted on
2019-03-06
Participant Flow
Participant milestones
| Measure |
Standard Care
Intervention: Subject intubated in routine fashion by the attending anesthesiologist with cuffed endotracheal tube; endotracheal tube cuff inflated; tube taped in place; depth measured bronchoscopically; patient asked to rate soreness of throat on verbal response scale when awake postoperatively.
cuff palpation: Inflated endotracheal tube cuff palpated through anterior extra-thoracic trachea while tube is gently moved to place the cuff midway between cricoid and sternal notch.
|
Cuff Palpation
Intervention: Subject intubated in routine fashion by the attending anesthesiologist with cuffed endotracheal tube; endotracheal tube cuff inflated; inflated cuff palpated and depth adjusted accordingly; tube taped in place; depth measured bronchoscopically; patient asked to rate soreness of throat on verbal response scale when awake postoperatively.
cuff palpation: Inflated endotracheal tube cuff palpated through anterior extra-thoracic trachea while tube is gently moved to place the cuff midway between cricoid and sternal notch.
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
44
|
|
Overall Study
COMPLETED
|
46
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tracheal Palpation of Sliding Cuff to Assess Endotracheal Tube Location
Baseline characteristics by cohort
| Measure |
Standard Care
n=46 Participants
Intervention: Subject intubated in routine fashion by the attending anesthesiologist with cuffed endotracheal tube; endotracheal tube cuff inflated; tube taped in place; depth measured bronchoscopically; patient asked to rate soreness of throat on verbal response scale when awake postoperatively.
|
Cuff Palpation
n=44 Participants
Intervention: Subject intubated in routine fashion by the attending anesthesiologist with cuffed endotracheal tube; endotracheal tube cuff inflated; inflated cuff palpated and depth adjusted accordingly; tube taped in place; depth measured bronchoscopically; patient asked to rate soreness of throat on verbal response scale when awake postoperatively.
cuff palpation: Inflated endotracheal tube cuff palpated through anterior extra-thoracic trachea while tube is gently moved to place the cuff midway between cricoid and sternal notch.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 16 • n=99 Participants
|
56 years
STANDARD_DEVIATION 16 • n=107 Participants
|
56 years
STANDARD_DEVIATION 14 • n=206 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: when patient awake (within 24 hours of intubation)Surrogate measure of tissue damage from moving the tube with cuff inflated = soreness of throat on an 11-point verbal pain scale, with 0 = no pain, and 10 the worst pain imaginable.
Outcome measures
| Measure |
Standard Care
n=46 Participants
Intervention: Subject intubated in routine fashion by the attending anesthesiologist with cuffed endotracheal tube; endotracheal tube cuff inflated; tube taped in place; depth measured bronchoscopically; patient asked to rate soreness of throat on verbal response scale when awake postoperatively.
|
Cuff Palpation
n=44 Participants
Intervention: Subject intubated in routine fashion by the attending anesthesiologist with cuffed endotracheal tube; endotracheal tube cuff inflated; inflated cuff palpated and depth adjusted accordingly; tube taped in place; depth measured bronchoscopically; patient asked to rate soreness of throat on verbal response scale when awake postoperatively.
cuff palpation: Inflated endotracheal tube cuff palpated through anterior extra-thoracic trachea while tube is gently moved to place the cuff midway between cricoid and sternal notch.
|
|---|---|---|
|
Sore Throat
|
1.5 units on a scale
Standard Deviation 2.1
|
0.6 units on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: immediate (within 5minutes of intubation).Population: Participants removed from analysis were all removed because of unavailable clean bronchoscope.
Endotracheal tube tip \>2.5cm from carina and \>5.5cm from vocal cords for women and \>6cm from vocal cords for men
Outcome measures
| Measure |
Standard Care
n=46 Participants
Intervention: Subject intubated in routine fashion by the attending anesthesiologist with cuffed endotracheal tube; endotracheal tube cuff inflated; tube taped in place; depth measured bronchoscopically; patient asked to rate soreness of throat on verbal response scale when awake postoperatively.
|
Cuff Palpation
n=44 Participants
Intervention: Subject intubated in routine fashion by the attending anesthesiologist with cuffed endotracheal tube; endotracheal tube cuff inflated; inflated cuff palpated and depth adjusted accordingly; tube taped in place; depth measured bronchoscopically; patient asked to rate soreness of throat on verbal response scale when awake postoperatively.
cuff palpation: Inflated endotracheal tube cuff palpated through anterior extra-thoracic trachea while tube is gently moved to place the cuff midway between cricoid and sternal notch.
|
|---|---|---|
|
Number of Participants With Correct Depth of Endotracheal Tube in Trachea,
|
19 Participants
|
29 Participants
|
Adverse Events
Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cuff Palpation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. William P. McKay
Dept. of Anesthesia, University of Saskatchewan
Phone: 306 655 1202
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place