Leak Pressure of Uncuffed Pediatric Endotracheal Tubes

NCT00968058 | Completed

• 1 other identifier: IRB00005347
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intubation, Endotracheal; Leak Pressure

Keywords

Leak Pressure; Intubation, Endotracheal; Pediatric; Temporal Variation

Outcome Measures

Primary Outcomes (1)

• Changes in leak pressure following endotracheal tube placement

  Thirty minutes after tube placement

Interventions

Leak Test Recording PROCEDURE

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

Eligibility Criteria

• Age: Up to 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Study Officials

• Kirk Lalwani, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor Anesthesiology and Pediatrics

Study Record Dates

• First Submitted: August 27, 2009
• First Posted: August 28, 2009
• Study Start: June 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: May 4, 2012

Record last verified: 2012-05

Locations

US (1)