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Leak Pressure of Uncuffed Pediatric Endotracheal Tubes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kirk Lalwani, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00968058
First received: August 27, 2009
Last updated: May 3, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Intubation, Endotracheal
Leak Pressure
Procedure: Leak Test Recording

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Temporal Variation of the Leak Pressure of Uncuffed Pediatric Endotracheal Tubes Following Intubation: A Prospective Observational Study

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Changes in leak pressure following endotracheal tube placement [ Time Frame: Thirty minutes after tube placement ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Leak Test Recording
    Recording of the Leak Pressure by the Leak Test at 0, 5, 10, 15, 20, 30 min timepoints
  Eligibility

Ages Eligible for Study:   up to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric patients undergoing surgical procedures at Oregon Health & Science University

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00968058

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Kirk Lalwani, Associate professor Anesthesiology and Pediatrics, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00968058     History of Changes
Other Study ID Numbers: IRB00005347
Study First Received: August 27, 2009
Last Updated: May 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Leak Pressure
Intubation, Endotracheal
Pediatric
Temporal Variation

ClinicalTrials.gov processed this record on November 20, 2014