No Post Intubation Laryngeal Symptoms

Dysphagia Clinical Trial

— No-PILS  

Official title:

Endotracheal Tube Clip for Prevention of Post Intubation Laryngeal Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05383417
• Other study ID #: 800842
• Status: Completed
• Phase: N/A
• Start date: November 8, 2022
• Est. completion date: September 21, 2023

Study information

• Verified date: December 2023
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 21, 2023
• Est. primary completion date: September 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient undergoing general endotracheal anesthesia with an endotracheal tube
• Patient is not undergoing a procedure in the head and neck region

Exclusion Criteria:

• Patient with pre-existing severe sore throat, voice change, or trouble swallowing
• Patient undergoing surgery in the head and neck region

Related Conditions & MeSH terms

• Anesthesia Complication
• Anesthesia Intubation Complication
• Anesthesia Morbidity
• Anesthesia; Adverse Effect
• Anesthesia; Reaction
• Deglutition Disorders
• Dysphagia
• Dysphonia
• Hoarseness
• Intubation Complication
• Pharyngitis
• Throat Disorder

Intervention

Device:
• EndoClip
Clip attached to mid portion of the endotracheal tube.

Locations

Country	Name	City	State
United States	UC San Diego Health	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sore throat on a visual analog scale from 0 (no sore throat) to 10 (worst possible sore throat)	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.	Baseline to 1 week after intervention
Primary	Change in voice on a visual analog scale from 0 (no voice change) to 10 (most severe voice change)	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.	Baseline to 1 week after intervention
Primary	Difficulty swallowing on a visual analog scale from 0 (no difficulty swallowing) to 10 (complete inability to swallow)	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.	Baseline to 1 week after intervention
Primary	Pain in the mouth on a visual analog scale from 0 (no mouth pain) to 10 (worst possible mouth pain)	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.	Baseline to 1 week after intervention
Primary	Difficulty talking on a visual analog scale from 0 (no difficulty talking) to 10 (complete inability to talk)	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.	Baseline to 1 week after intervention
Primary	Pain in the neck/chest on a visual analog scale from 0 (no neck/chest pain) to 10 (worst possible neck/chest pain)	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.	Baseline to 1 week after intervention