Trial Outcomes & Findings for No Post Intubation Laryngeal Symptoms (NCT NCT05383417)

NCT ID: NCT05383417

Last Updated: 2025-09-10

Results Overview

Subjects will indicate whether they are experiencing a sore throat or throat discomfort on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no sore throat) to 10 (worst possible sore throat). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: Baseline to 1 week after intervention
• Results posted on: 2025-09-10

Participant Flow

100 subjects recruited in an outpatient surgery center at University of California San Diego Health from November 2022 to September 2023.

Participant milestones

Measure	EndoClip Clip applied to endotracheal tube. EndoClip: Clip attached to mid portion of the endotracheal tube.	No Clip No clip applied to endotracheal tube.
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

No Post Intubation Laryngeal Symptoms

Baseline characteristics by cohort

Measure	EndoClip n=50 Participants Clip applied to endotracheal tube. EndoClip: Clip attached to mid portion of the endotracheal tube.	No Clip n=50 Participants No clip applied to endotracheal tube.	Total n=100 Participants Total of all reporting groups
Age, Continuous	55 years n=5 Participants	48 years n=7 Participants	52 years n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	31 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	19 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=5 Participants	38 Participants n=7 Participants	79 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	28 Participants n=7 Participants	55 Participants n=5 Participants
Race (NIH/OMB) More than one race	14 Participants n=5 Participants	17 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 1 week after intervention

Subjects will indicate whether they are experiencing a sore throat or throat discomfort on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no sore throat) to 10 (worst possible sore throat). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.

Outcome measures

Measure	EndoClip n=50 Participants Clip applied to endotracheal tube. EndoClip: Clip attached to mid portion of the endotracheal tube.	No Clip n=50 Participants No clip applied to endotracheal tube.
Sore Throat on a Scale From 0 (no Sore Throat) to 10 (Worst Possible Sore Throat) Day 2 - 2 days after intubation	0.53 score on a scale Standard Deviation 1	1.12 score on a scale Standard Deviation 1.94
Sore Throat on a Scale From 0 (no Sore Throat) to 10 (Worst Possible Sore Throat) Day 7 - 7 days after intubation	0.18 score on a scale Standard Deviation 0.69	0.43 score on a scale Standard Deviation 1.25
Sore Throat on a Scale From 0 (no Sore Throat) to 10 (Worst Possible Sore Throat) Day 0 - after intubation on day of discharge	1.85 score on a scale Standard Deviation 2.44	1.9 score on a scale Standard Deviation 2.34
Sore Throat on a Scale From 0 (no Sore Throat) to 10 (Worst Possible Sore Throat) Day 1 - day after intubation	1.1 score on a scale Standard Deviation 1.52	1.62 score on a scale Standard Deviation 2.22

PRIMARY outcome

Timeframe: Baseline to 1 week after intervention

Subjects will indicate whether they are experiencing a change in voice (i.e. deep and/or hoarse voice, worse than their usual voice quality) on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no voice change) to 10 (most severe voice change). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.

Outcome measures

Measure	EndoClip n=50 Participants Clip applied to endotracheal tube. EndoClip: Clip attached to mid portion of the endotracheal tube.	No Clip n=50 Participants No clip applied to endotracheal tube.
Change in Voice on a Scale From 0 (no Voice Change) to 10 (Most Severe Voice Change) Day 0 - after intubation on day of discharge	1.87 score on a scale Standard Deviation 2.12	2.21 score on a scale Standard Deviation 2.79
Change in Voice on a Scale From 0 (no Voice Change) to 10 (Most Severe Voice Change) Day 1 - day after intubation	1.13 score on a scale Standard Deviation 1.66	1.30 score on a scale Standard Deviation 2.17
Change in Voice on a Scale From 0 (no Voice Change) to 10 (Most Severe Voice Change) Day 2 - 2 days after intubation	0.59 score on a scale Standard Deviation 1.14	0.83 score on a scale Standard Deviation 1.46
Change in Voice on a Scale From 0 (no Voice Change) to 10 (Most Severe Voice Change) Day 7 - 7 days after intubation	0.26 score on a scale Standard Deviation 0.8	0.27 score on a scale Standard Deviation 0.7

PRIMARY outcome

Timeframe: Baseline to 1 week after intervention

Subjects will indicate whether they are experiencing difficulty swallowing on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no difficulty swallowing) to 10 (complete inability to swallow). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.

Outcome measures

Measure	EndoClip n=50 Participants Clip applied to endotracheal tube. EndoClip: Clip attached to mid portion of the endotracheal tube.	No Clip n=50 Participants No clip applied to endotracheal tube.
Difficulty Swallowing on a Scale From 0 (no Difficulty Swallowing) to 10 (Complete Inability to Swallow) Day 0 - after intubation on day of discharge	1.04 score on a scale Standard Deviation 2.16	1.21 score on a scale Standard Deviation 2.16
Difficulty Swallowing on a Scale From 0 (no Difficulty Swallowing) to 10 (Complete Inability to Swallow) Day 1 - day after intubation	0.58 score on a scale Standard Deviation 1.49	1.13 score on a scale Standard Deviation 2.14
Difficulty Swallowing on a Scale From 0 (no Difficulty Swallowing) to 10 (Complete Inability to Swallow) Day 2 - 2 days after intubation	0.20 score on a scale Standard Deviation 0.68	0.94 score on a scale Standard Deviation 1.97
Difficulty Swallowing on a Scale From 0 (no Difficulty Swallowing) to 10 (Complete Inability to Swallow) Day 7 - 7 days after intubation	0.1 score on a scale Standard Deviation 0.58	0.49 score on a scale Standard Deviation 1.46

PRIMARY outcome

Timeframe: Baseline to 1 week after intervention

Subjects will indicate whether they are experiencing mouth pain on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no mouth pain) to 10 (worst possible mouth pain). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.

Outcome measures

Measure	EndoClip n=50 Participants Clip applied to endotracheal tube. EndoClip: Clip attached to mid portion of the endotracheal tube.	No Clip n=50 Participants No clip applied to endotracheal tube.
Pain in the Mouth on a Scale From 0 (no Mouth Pain) to 10 (Worst Possible Mouth Pain) Day 0 - after intubation on day of discharge	0.07 score on a scale Standard Deviation 0.33	0.42 score on a scale Standard Deviation 1.58
Pain in the Mouth on a Scale From 0 (no Mouth Pain) to 10 (Worst Possible Mouth Pain) Day 1 - day after discharge	0.06 score on a scale Standard Deviation 0.32	0.28 score on a scale Standard Deviation 0.77
Pain in the Mouth on a Scale From 0 (no Mouth Pain) to 10 (Worst Possible Mouth Pain) Day 2 - 2 days after intubation	0.04 score on a scale Standard Deviation 0.29	0.27 score on a scale Standard Deviation 1.19
Pain in the Mouth on a Scale From 0 (no Mouth Pain) to 10 (Worst Possible Mouth Pain) Day 7 - 7 days after intubation	0.02 score on a scale Standard Deviation 0.14	0.12 score on a scale Standard Deviation 0.39

PRIMARY outcome

Timeframe: Baseline to 1 week after intervention

Subjects will indicate whether they are experiencing difficulty talking on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no difficulty talking) to 10 (complete inability to talk). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.

Outcome measures

Measure	EndoClip n=50 Participants Clip applied to endotracheal tube. EndoClip: Clip attached to mid portion of the endotracheal tube.	No Clip n=50 Participants No clip applied to endotracheal tube.
Difficulty Talking on a Scale From 0 (no Difficulty Talking) to 10 (Complete Inability to Talk) Day 0 - after intubation on day of discharge	0.87 score on a scale Standard Deviation 1.96	1.09 score on a scale Standard Deviation 2.11
Difficulty Talking on a Scale From 0 (no Difficulty Talking) to 10 (Complete Inability to Talk) Day 2 - 2 days after intubation	0.29 score on a scale Standard Deviation 1	0.61 score on a scale Standard Deviation 1.43
Difficulty Talking on a Scale From 0 (no Difficulty Talking) to 10 (Complete Inability to Talk) Day 7 - 7 days after intubation	0.1 score on a scale Standard Deviation 0.42	0.27 score on a scale Standard Deviation 0.7
Difficulty Talking on a Scale From 0 (no Difficulty Talking) to 10 (Complete Inability to Talk) Day 1 - day after intubation	0.35 score on a scale Standard Deviation 1.36	0.96 score on a scale Standard Deviation 1.96

PRIMARY outcome

Timeframe: Baseline to 1 week after intervention

Subjects will indicate whether they are experiencing pain in the anterior or low region of the neck and/or chest on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no neck/chest pain) to 10 (worst possible neck/chest pain). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.

Outcome measures

Measure	EndoClip n=50 Participants Clip applied to endotracheal tube. EndoClip: Clip attached to mid portion of the endotracheal tube.	No Clip n=50 Participants No clip applied to endotracheal tube.
Pain in the Neck/Chest on a Scale From 0 (no Neck/Chest Pain) to 10 (Worst Possible Neck/Chest Pain) Day 0 - after intubation on day of discharge	0.37 score on a scale Standard Deviation 1.44	0.77 score on a scale Standard Deviation 2.08
Pain in the Neck/Chest on a Scale From 0 (no Neck/Chest Pain) to 10 (Worst Possible Neck/Chest Pain) Day 1 - day after intubation	0.25 score on a scale Standard Deviation 0.96	0.68 score on a scale Standard Deviation 1.77
Pain in the Neck/Chest on a Scale From 0 (no Neck/Chest Pain) to 10 (Worst Possible Neck/Chest Pain) Day 2 - 2 days after intubation	0.16 score on a scale Standard Deviation 0.51	0.71 score on a scale Standard Deviation 1.83
Pain in the Neck/Chest on a Scale From 0 (no Neck/Chest Pain) to 10 (Worst Possible Neck/Chest Pain) Day 7 - 7 days after intubation	0.06 score on a scale Standard Deviation 0.31	0.29 score on a scale Standard Deviation 1.08

PRIMARY outcome

Timeframe: 7 days

Patients with post operative mouth pain during the first post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below.

Outcome measures

Measure	EndoClip n=193 completed surveys Clip applied to endotracheal tube. EndoClip: Clip attached to mid portion of the endotracheal tube.	No Clip n=188 completed surveys No clip applied to endotracheal tube.
Patients With Post Operative Mouth Pain	6 participants with symptoms	24 participants with symptoms

PRIMARY outcome

Timeframe: 7 days

Patients with post operative sore throat during the first post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below.

Outcome measures

Measure	EndoClip n=193 number of surveys complete Clip applied to endotracheal tube. EndoClip: Clip attached to mid portion of the endotracheal tube.	No Clip n=188 number of surveys complete No clip applied to endotracheal tube.
Patients With Post Operative Sore Throat	65 participants with symptoms	82 participants with symptoms

PRIMARY outcome

Timeframe: 7 days

Patients with post operative neck/chest pain during the first post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below.

Outcome measures

Measure	EndoClip n=193 surveys completed Clip applied to endotracheal tube. EndoClip: Clip attached to mid portion of the endotracheal tube.	No Clip n=188 surveys completed No clip applied to endotracheal tube.
Patients With Post Operative Neck/Chest Pain	16 participants with symptoms	35 participants with symptoms

PRIMARY outcome

Timeframe: 7 days

Patients with post operative voice change over the post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below.

Outcome measures

Measure	EndoClip n=193 surveys completed Clip applied to endotracheal tube. EndoClip: Clip attached to mid portion of the endotracheal tube.	No Clip n=187 surveys completed No clip applied to endotracheal tube.
Patients With Post Operative Voice Change	66 participants with symptoms	67 participants with symptoms

PRIMARY outcome

Timeframe: 7 days

Patients with post operative difficulty talking over the post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below.

Outcome measures

Measure	EndoClip n=193 surveys completed Clip applied to endotracheal tube. EndoClip: Clip attached to mid portion of the endotracheal tube.	No Clip n=188 surveys completed No clip applied to endotracheal tube.
Patients With Post Operative Difficulty Talking	24 participants with symptoms	49 participants with symptoms

PRIMARY outcome

Timeframe: 7 days

Patients with post operative difficulty swallowing over there first post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below.

Outcome measures

Measure	EndoClip n=193 surveys completed Clip applied to endotracheal tube. EndoClip: Clip attached to mid portion of the endotracheal tube.	No Clip n=188 surveys completed No clip applied to endotracheal tube.
Patients With Post Operative Difficulty Swallowing	31 participants with symptoms	60 participants with symptoms

Adverse Events

EndoClip

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Clip

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. Andrew Vahabzadeh-Hagh

University of California San Diego Health

Phone: 858-249-4070

Email: avahabz@health.ucsd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place