No-PILS: No Post Intubation Laryngeal Symptoms

Sponsor

University of California, San Diego (Other)

Overall Status

Recruiting

CT.gov ID

NCT05383417

Collaborator

(none)

100

Enrollment

Location

Arms

12.4

Anticipated Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to test a novel endotracheal tube support device that reduces pressure of the tube on the voice box for prevention of post intubation laryngeal symptoms including sore throat, change in voice and trouble swallowing.

Condition or Disease	Intervention/Treatment	Phase
Sore-throat Dysphonia Dysphagia Intubation Complication Anesthesia Intubation Complication Anesthesia Morbidity Anesthesia Complication Anesthesia; Adverse Effect Anesthesia; Reaction Throat Disorder Throat; Wound Throat Injury	Device: EndoClip	N/A

Detailed Description

Single center randomized controlled trial with 100 subjects who will be intubated for already planned surgeries. The participants will be randomized into the control group or the clip group. The clip group will have a small clip (the endotracheal tube support device) placed on the endotracheal tube to reduce the pressure on the vocal cords and larynx. This endotracheal tube support device is made from a FDA approved biocompatible material.

The control group subjects will undergo their planned procedure with no intervention during intubation. The clip group will undergo their planned procedure as normal but with the endotracheal tube support device placed on the endotracheal tube by the assigned anesthesia attending physician. The clip is placed once the tube is secured and the ventilator circuit is connected. While extubating the patient, the endotracheal tube will be removed with the clip attached and a picture of the tube will be taken to record the clip location.

Before the planned procedure, the investigators will survey the participants to get a baseline for any pre-existing laryngeal symptoms. The same survey will be administered after the procedure when the participants are awake and alert just prior to discharge, 24 hours, 48 hours, and 1 week after the procedure. The survey will ask the participant to indicate "yes" or "no" for whether they are experiencing a sore throat, throat pain, oral pain, difficulty speaking, difficulty swallowing, changes in their voice, pain while speaking, and pain while swallowing. If they have indicated "yes" for any of the symptoms, the participants will also be asked to mark the severity on a visual analog scale from 1 to 10.

Other data points will also be collected in this study that are related to the intubation and participant's airway. The investigators will record the total time of the procedure and the length of time the clip is placed on the endotracheal tube. For each participant in the clip group, the investigators will also record the time it takes to place the clip on the endotracheal tube. Each participant's airway will be evaluated, and the investigators will record the thyromental distance, Mallampati score, history of difficult intubation, and the size of the endotracheal tube used. Lastly, data from each participant's intubation will be collected including number of attempts before successful intubation, incidence of dental injury, incidence of lip injury, laryngeal view on Cormack-Lehane scale, and any noted trauma upon extubation. Lastly, the investigators will have the anesthesiologists recruited for the study fill out a modified National Aeronautics and Space Administration (NASA) Task Load Index (TLX) form to evaluate the end-user experience for the device.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

2 arm parallel trial where one group will receive the endotracheal tube clip during general endotracheal anesthesia and the other group will not.2 arm parallel trial where one group will receive the endotracheal tube clip during general endotracheal anesthesia and the other group will not.

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Patient will not be aware of their treatment arm. Investigator and Care Provider will be aware of treatment are but data analysis (outcomes assessor) will be blinded to treatment groups.

Primary Purpose:

Prevention

Official Title:

Endotracheal Tube Clip for Prevention of Post Intubation Laryngeal Symptoms

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

May 31, 2023

Anticipated Study Completion Date :

Jun 14, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EndoClip Clip applied to endotracheal tube.	Device: EndoClip Clip attached to mid portion of the endotracheal tube. Other Names: Endotracheal tube clip
No Intervention: No Clip No clip applied to endotracheal tube.

Arm

Intervention/Treatment

Experimental: EndoClip

Clip applied to endotracheal tube.

Device: EndoClip

Clip attached to mid portion of the endotracheal tube.

Other Names:

Endotracheal tube clip

No Intervention: No Clip

No clip applied to endotracheal tube.

Outcome Measures

Primary Outcome Measures

Sore throat on a visual analog scale from 0 (no sore throat) to 10 (worst possible sore throat) [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 visual analog 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.
Change in voice on a visual analog scale from 0 (no voice change) to 10 (most severe voice change) [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 visual analog 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.
Difficulty swallowing on a visual analog scale from 0 (no difficulty swallowing) to 10 (complete inability to swallow) [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 visual analog 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.
Pain in the mouth on a visual analog scale from 0 (no mouth pain) to 10 (worst possible mouth pain) [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 visual analog 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.
Difficulty talking on a visual analog scale from 0 (no difficulty talking) to 10 (complete inability to talk) [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 visual analog 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.
Pain in the neck/chest on a visual analog scale from 0 (no neck/chest pain) to 10 (worst possible neck/chest pain) [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 visual analog 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.