Force of Endotracheal Tube Extubation; Esophagus vs. Trachea

NCT03480425 | Terminated Results

• 1 other identifier: Bio# 17-273
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

A study of a new approach to determining if, following endotracheal intubation, the endotracheal tube (ETT) is in the trachea or the esophagus. The test for correct placement consists of inflating the cuff to a pressure of 50 (to be determined by the study) and tugging the ETT gently up and out of the mouth. The investigators hypothesize that if it is in the esophagus, it will slide easily all the way out; if in the trachea, the cuff will be impeded by catching on the lower surface of the cricoid ring, and that this will require a greater force to extubate with cuff inflated than that required for the esophagus.

Conditions

Intubation, Intratracheal

Outcome Measures

Primary Outcomes (1)

• Withdrawal Force.

  Force (N) of resistance to pulling the tube out compared for esophageal versus tracheal intubation

  1 year

Study Arms (1)

Esophageal then tracheal intubated patient

EXPERIMENTAL

Esophagus is intentionally intubated with a cuffed endotracheal tube, the cuff inflated to \>30cm water pressure, a force transducer attached, and force of extubation recorded. Then Trachea is intentionally intubated the cuff inflated to \>30cm water pressure, and force of extubation recorded.

Diagnostic Test: Measuring extubation force

Interventions

Measuring extubation force DIAGNOSTIC_TEST

Intubation of the esophagus of anesthetized participants who are having planned endotracheal intubate for surgery; inflation of the cuff; attachment of a force transducer to the tube connector; and gently tugging the tube out of the mouth. Then intubating the esophagus and repeating the tugging procedure. Meanwhile, the force of resistance to tugging is measured with a force transducer.

Esophageal then tracheal intubated patient

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

Saskatoon Health Region, 410 22nd Street East

Saskatoon, Saskatchewan, S7K 5T6, Canada

Location

Results Point of Contact

• Title: Dr. William P. McKay
• Organization: University of Saskatchewan

bill.mckay@usask.ca

306 250 5344

Study Officials

• William P McKay, MD

  University of Saskatchewan Dept. of Anesthesiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emeritus

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: March 29, 2018
• Study Start: March 3, 2018
• Primary Completion: April 19, 2018
• Study Completion: April 19, 2018
• Last Updated: May 14, 2020
• Results First Posted: May 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)