Anesthesia Intubation Complication Clinical Trial
Official title:
Tracheal Palpation of Sliding Cuff to Assess Endotracheal Tube Location in Trachea - A Randomized Controlled Trial
NCT number | NCT02502461 |
Other study ID # | Bio#15-63 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2015 |
Est. completion date | September 11, 2016 |
Verified date | November 2018 |
Source | University of Saskatchewan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | September 11, 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Saskatoon Health Region, 410 22nd Street East | Saskatoon | Saskatchewan |
Lead Sponsor | Collaborator |
---|---|
University of Saskatchewan |
Canada,
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. Erratum in: Can J Anaesth. 2014 — View Citation
Owen RL, Cheney FW. Endobronchial intubation: a preventable complication. Anesthesiology. 1987 Aug;67(2):255-7. — View Citation
Pollard RJ, Lobato EB. Endotracheal tube location verified reliably by cuff palpation. Anesth Analg. 1995 Jul;81(1):135-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Number of Participants With Correct Depth of Endotracheal Tube in Trachea, | Endotracheal tube tip >2.5cm from carina and >5.5cm from vocal cords for women and >6cm from vocal cords for men | immediate (within 5minutes of intubation). |
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