Ignite Creation Date:
2024-05-06 @ 5:39 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05383417
Status:
COMPLETED
Last Update Posted:
2023-12-07
First Post:
2022-05-10
Brief Title:
No Post Intubation Laryngeal Symptoms
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Endotracheal Tube Clip for Prevention of Post Intubation Laryngeal Symptoms
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
No-PILS
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
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 participants 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 participants 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 participants 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
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 participants 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 participants 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 participants 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None