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EndoClip for Anesthesia Intubation Complications (No-PILS Trial)

N/A

Waitlist Available

Led By Andrew Vahabzadeh-Hagh, MD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 1 week after intervention

Awards & highlights

No-PILS Trial Summary

This trial tests a new device that stops an endotracheal tube from putting pressure on the voice box, which could prevent symptoms like a sore throat, change in voice, and trouble swallowing after intubation.

Eligible Conditions

Anesthesia Intubation Complications
Throat Disorders
Throat Injury
Sore Throat
Endotracheal Intubation
Anesthesia Morbidity
Anesthesia Complications
Anesthesia Awareness
Anesthetic Reaction
Hoarseness
Swallowing Difficulty

No-PILS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 1 week after intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 1 week after intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 1 week after intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in voice on a visual analog scale from 0 (no voice change) to 10 (most severe voice change)

Difficulty swallowing on a visual analog scale from 0 (no difficulty swallowing) to 10 (complete inability to swallow)

Difficulty talking on a visual analog scale from 0 (no difficulty talking) to 10 (complete inability to talk)

+3 more

No-PILS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: EndoClipExperimental Treatment1 Intervention

Clip applied to endotracheal tube.

Group II: No ClipActive Control1 Intervention

No clip applied to endotracheal tube.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

EndoClip

2022

N/A

~100

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,120 Previous Clinical Trials

1,521,307 Total Patients Enrolled

Andrew Vahabzadeh-Hagh, MDPrincipal InvestigatorUC San Diego Health

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still open for participants of this research study?

"Affirmative. The information hosted on clinicaltrials.gov demonstrates that this experiment is actively accepting participants, with the original listing posted on June 1st 2022 and most recently updated May 16th 2022. This research requires 100 volunteers across a single medical centre to participate."

Answered by AI

How many participants has the study managed to recruit thus far?

"Yes, the information hosted on clinicaltrials.gov confirms that this medical trial is currently recruiting patients; it was originally posted on June 1st 2022 and updated most recently on May 16th 2022. The aim of the research study is to recruit 100 participants from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

No Post Intubation Laryngeal Symptoms

Andrew Vahabzadeh-Hagh 2022. "No Post Intubation Laryngeal Symptoms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05383417.