Leak Pressure of Uncuffed Pediatric Endotracheal Tubes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intubation, Endotracheal Leak Pressure

Age range

Up to 7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Leak Test Recording

Procedure

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

Primary outcomes

Changes in leak pressure following endotracheal tube placement

Time frame: Thirty minutes after tube placement

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Aug 28, 2009
Registry last updated: May 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed