Trial Outcomes & Findings for Post-operative Sore Throat as Determined by Endotracheal Tube Inflation Technique (NCT NCT01305265)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

141 participants

Primary outcome timeframe

within 2 hours after extubation

Results posted on

2014-02-26

Participant milestones
Measure	Control Group Endotracheal tube cuff will be inflated using the inflate\&palpate technique	Intervention Group Endotracheal tube cuff will be inflated using the inflate \& palpate technique. The cuff pressure will be adjusted to 22-26cmH2O within 15min after intubation by trained study staff.
Overall Study STARTED	71	70
Overall Study COMPLETED	69	64
Overall Study NOT COMPLETED	2	6

Withdrawal data not reported

Post-operative Sore Throat as Determined by Endotracheal Tube Inflation Technique

Baseline characteristics by cohort
Measure	Control Group n=69 Participants Endotracheal tube cuff inflated using the inflate \& palpate technique	Intervention Group n=64 Participants Endotracheal tube cuff inflated using the inflate \& palpate technique. The cuff pressure then was adjusted to 22-26cmH2O within 15min after endotracheal intubation by trained study staff.	Total n=133 Participants Total of all reporting groups
Age, Continuous	52.4 years STANDARD_DEVIATION 15.8 • n=5 Participants	50.3 years STANDARD_DEVIATION 13.8 • n=7 Participants	51.4 years STANDARD_DEVIATION 14.9 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	34 Participants n=7 Participants	66 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	30 Participants n=7 Participants	67 Participants n=5 Participants
Region of Enrollment United States	69 participants n=5 Participants	64 participants n=7 Participants	133 participants n=5 Participants

Timeframe: within 2 hours after extubation

Outcome measures
Measure	Control Group n=69 Participants Endotracheal tube cuff will be inflated using the inflate\&palpate technique	Intervention Group n=64 Participants Endotracheal tube cuff will be inflated using the inflate \& palpate technique. The cuff pressure will be adjusted to 22-26cmH2O within 15min after intubation by trained study staff.
Incidence of Tracheopharyngeal Symptoms	53 participants	49 participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Dept. of Anesthesia & Perioperative Care, UCSF San Francisco

Phone: 4158853647