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CompletedNCT00968058Updated May 4, 2012

Leak Pressure of Uncuffed Pediatric Endotracheal Tubes

An observational study in Intubation, Endotracheal and Leak Pressure, sponsored by Oregon Health and Science University. Completed at 1 site in United States. Open to participants aged Up to 7 Years. Per ClinicalTrials.gov, last updated 2012-05-04.

Sponsored by Oregon Health and Science University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
40
Ages
Up to 7 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Intubation, Endotracheal
  • Leak Pressure

Keywords

  • Leak Pressure
  • Intubation, Endotracheal
  • Pediatric
  • Temporal Variation
03

In context

Lead sponsor

Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 7 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pediatric patients undergoing surgical procedures at Oregon Health \& Science University

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
40 participants (estimated)

Interventions

  • ProcedureLeak Test Recording

    Recording of the Leak Pressure by the Leak Test at 0, 5, 10, 15, 20, 30 min timepoints

06

What researchers measure

Primary outcomes

  1. Changes in leak pressure following endotracheal tube placement

    Time frame: Thirty minutes after tube placement

07

Study locations

1 site
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00968058
Lead sponsor
Oregon Health and Science University
Responsible party
Kirk Lalwani (Associate professor Anesthesiology and Pediatrics, Oregon Health and Science University) — Principal investigator
First posted
Aug 28, 2009
Start date
Jun 2009
Primary completion
Jul 2011
Completion
Jul 2011
Last update
May 4, 2012

Study contacts

Kirk Lalwani, MD
principal investigator · Oregon Health and Science University
Shreya J Patel, BS
study director · University of Arizona College of Medicine
Jeffrey Koh, MD
study director · Oregon Health and Science University
Rochelle Fu, PhD
study director · Oregon Health and Science University
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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