Leak Pressure of Uncuffed Pediatric Endotracheal Tubes

May 3, 2012 updated by: Kirk Lalwani, Oregon Health and Science University

Temporal Variation of the Leak Pressure of Uncuffed Pediatric Endotracheal Tubes Following Intubation: A Prospective Observational Study

Children and adults frequently need a 'breathing tube' when having anesthesia for surgery. The breathing tube is usually inserted after the anesthesia doctor puts a patient to sleep with medicine, so they do not feel the breathing tube. In children, there is often a leak of air between the tube and the windpipe, as the tube is not an exact fit. Anesthesia doctors usually listen for this leak around the tube by listening to the chest with a stethoscope while gently filling the lungs with oxygen from the anesthesia machine. The leak tells them if the tube is the correct size, or too small, or too tight. If it is too small, or too tight, they usually change the tube for a better fit.

The purpose of this study is to see what happens to this leak in the 30 minutes after the tube is placed. No one really knows if the leak gets bigger, smaller, or stays the same. Knowing what happens to the leak will help anesthesia doctors to decide whether to change the breathing tube or not. This is important, as a tube that is too tight can lead to breathing difficulty after removing the tube at the end of surgery, and a tube that is too small may make it difficult for the breathing machine to work effectively for the patient as a result of a large leak of air or oxygen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients undergoing surgical procedures at Oregon Health & Science University

Description

Inclusion Criteria:

  • Children aged 0-7 years of age
  • Surgery with planned endotracheal intubation using an uncuffed ETT.
  • ASA 1-3
  • Supine position

Exclusion Criteria:

  • Lack of parental consent
  • Rapid sequence induction with cricoid pressure
  • Use of neuromuscular blocking agent/s for intubation.
  • Active gastroesophageal reflux disease
  • Active upper respiratory tract infection
  • Chronic active lung disease requiring frequent treatment such as asthma, or chronic lung disease of prematurity etc.
  • Surgery in the lateral or prone position
  • Oropharyngeal, neck , laryngeal, or laparoscopic surgery
  • Tracheostomy in-situ
  • History of previous laryngeal or tracheal surgery
  • History of tracheal or laryngeal abnormalities, or stridor of unknown origin.
  • History of symptomatic neuromuscular disease or paralysis
  • History or features suggestive of a difficult airway on pre-anesthetic evaluation and physical examination.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in leak pressure following endotracheal tube placement
Time Frame: Thirty minutes after tube placement
Thirty minutes after tube placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Investigators

  • Principal Investigator: Kirk Lalwani, MD, Oregon Health and Science University
  • Study Director: Shreya J Patel, BS, University of Arizona College of Medicine
  • Study Director: Jeffrey Koh, MD, Oregon Health and Science University
  • Study Director: Rochelle Fu, PhD, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

August 27, 2009

First Submitted That Met QC Criteria

August 27, 2009

First Posted (Estimate)

August 28, 2009

Study Record Updates

Last Update Posted (Estimate)

May 4, 2012

Last Update Submitted That Met QC Criteria

May 3, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00005347

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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