Tracheal Palpation of Sliding Cuff to Assess Endotracheal Tube Location

NCT02502461 | Completed Results DMC

• 1 other identifier: Bio#15-63
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Correct endotracheal tube (ETT) placement is important. Proper ETT position is achieved when the distal tip is in mid-trachea with the head in neutral alignment. Unrecognized tube misplacement is an uncommon but significant cause of hypoxemia and death during general anesthesia as well as in the care of critically ill patients. Hypotheses: A specific manoeuvre to palpate the inflated ETT cuff, with fingers anterior to the trachea, moving the ETT caudally then rostrally following intubation, will enable correct depth placement of the tip of the ETT within the trachea (more than 2.5cm above the carina with cuff below the vocal cords) more frequently than routine care. This will not cause tissue damage as measured by sore throat.

Conditions

Anesthesia Intubation Complication

Outcome Measures

Primary Outcomes (1)

• Sore Throat

  Surrogate measure of tissue damage from moving the tube with cuff inflated = soreness of throat on an 11-point verbal pain scale, with 0 = no pain, and 10 the worst pain imaginable.

  when patient awake (within 24 hours of intubation)

Secondary Outcomes (1)

• Number of Participants With Correct Depth of Endotracheal Tube in Trachea,

  immediate (within 5minutes of intubation).

Study Arms (2)

standard care

SHAM COMPARATOR

Intervention: Subject intubated in routine fashion by the attending anesthesiologist with cuffed endotracheal tube; endotracheal tube cuff inflated; tube taped in place; depth measured bronchoscopically; patient asked to rate soreness of throat on verbal response scale when awake postoperatively.

Procedure: cuff palpation

cuff palpation

ACTIVE COMPARATOR

Intervention: Subject intubated in routine fashion by the attending anesthesiologist with cuffed endotracheal tube; endotracheal tube cuff inflated; inflated cuff palpated and depth adjusted accordingly; tube taped in place; depth measured bronchoscopically; patient asked to rate soreness of throat on verbal response scale when awake postoperatively.

Procedure: cuff palpation

Interventions

cuff palpation PROCEDURE

Inflated endotracheal tube cuff palpated through anterior extra-thoracic trachea while tube is gently moved to place the cuff midway between cricoid and sternal notch.

cuff palpation; standard care

Eligibility Criteria

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

You may qualify if:

• American Society of Anesthesiologists (ASA) Class I and II patients
• ≥18 years of age
• undergoing elective surgical procedures in the Saskatoon acute care hospitals of the Saskatoon Health Region
• requiring endotracheal intubation as a component of the anesthetic plan.

You may not qualify if:

• those who are physiologically unstable
• when there is urgency to proceed with surgery
• patients requiring rapid sequence induction
• those with respiratory distress
• those for whom the attending anaesthesiologist feels it would compromise safety for any reason.

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

Saskatoon Health Region, 410 22nd Street East

Saskatoon, Saskatchewan, S7K 5T6, Canada

Location

Related Publications (3)

• Owen RL, Cheney FW. Endobronchial intubation: a preventable complication. Anesthesiology. 1987 Aug;67(2):255-7. doi: 10.1097/00000542-198708000-00019. No abstract available.

  PMID: 3605754 BACKGROUND

• Pollard RJ, Lobato EB. Endotracheal tube location verified reliably by cuff palpation. Anesth Analg. 1995 Jul;81(1):135-8. doi: 10.1097/00000539-199507000-00027.

  PMID: 7598242 BACKGROUND

• McKay WP, Klonarakis J, Pelivanov V, O'Brien JM, Plewes C. Tracheal palpation to assess endotracheal tube depth: an exploratory study. Can J Anaesth. 2014 Mar;61(3):229-34. doi: 10.1007/s12630-013-0079-4. Epub 2013 Nov 21.

  PMID: 24259250 RESULT

Results Point of Contact

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

bill.mckay@usask.ca

306 655 1202

Study Officials

• William P McKay, MD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant is fully anesthetized. 1)Depth of ETT not known or knowable until after objective measurement. 2) Pain assessor unaware of participant group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia

Model Details: Double-blind RCT

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: July 20, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: September 11, 2016
• Last Updated: March 6, 2019
• Results First Posted: March 6, 2019

Record last verified: 2018-11

Locations

CA (1)