Anesthetic Gas Leakage in Children During Tonsillectomy: a Comparison of Cuffed and Uncuffed Tracheal Tubes

February 10, 2017 updated by: Jerrold Lerman, State University of New York at Buffalo
Fires and operating room pollution may occur when anesthesia gases leak into the oropharynx during airway surgery. Investigators sought to measure the concentrations of anesthetic gases that leak into the mouth of children undergoing adenotonsillectomy using cuffed and uncuffed tracheal tubes during spontaneous and controlled ventilation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

For the past 6 decades, uncuffed tubes have been used for the children less than 8 years of age out of a fear that cuffed tubes would cause damage to the subglottic region. The correct size uncuffed tube creates a seal in the subglottis that has minimal pressure on the mucosa. However, cuffed tubes have become more widely used in children recently without causing damage to the mucosa. There is very little literature comparing the magnitude of the gas leaks with cuffed and uncuffed tracheal tubes particularly in children. Several authors suggest that the leak of nitrous oxide and sevoflurane with uncuffed tubes was much greater than with cuffed tubes. One important but poorly studied issue is the risk of an airway fire when cautery is used for tonsillectomy because a large leak of oxygen in the mouth could ignite a fire. It also remains unclear whether the mode of ventilation, spontaneous or controlled, affects the leak of gases into the mouth. One might expect that the gas leak with spontaneous ventilation is less than with controlled ventilation, but it may not matter in the context of the small concentrations of oxygen and sevoflurane that investigators use. To address all of these concerns, investigators designed this study to compare the concentrations of gases (oxygen, carbon dioxide, nitrous oxide and sevoflurane) in the oral cavity of children undergoing T&A with either cuffed or uncuffed tubes, during spontaneous and controlled ventilation.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

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

1 year to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. American society of anesthesiologists physical status 1 and 2;
  2. fasted
  3. scheduled for elective adenotonsillectomy

Exclusion Criteria:

  1. refusal of consent by parents
  2. difficult tracheal intubation
  3. craniofacial anomalies
  4. gastroesophageal reflux
  5. malignant hyperthermia
  6. randomization to a tracheal tube is unacceptable.

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Uncuffed tracheal tubes
After tracheal intubation with an uncuffed tube, the interventions will be the oxygen concentration, nitrous oxide concentration, carbon dioxide concentration and sevoflurane concentration measured in the tracheal tube compared with those in the oropharynx during spontaneous and controlled ventilation.
Drug: oxygen concentration
oxygen concentration will be measured in the tracheal tube and oropharynx during spontaneous or controlled ventilation
Other Names:
  • difference in the oxygen concentration
Drug: nitrous oxide concentration
nitrous oxide concentration will be measured in the tracheal tube and oropharynx during spontaneous or controlled ventilation
Other Names:
  • difference in the nitrous oxide concentration
Drug: carbon dioxide concentration
carbon dioxide concentration will be measured from the tracheal tube and in the oropharynx during spontaneous or controlled ventilation
Other Names:
  • difference in the carbon dioxide concentration
Drug: sevoflurane concentration
sevoflurane concentration will be measured in the tracheal tube and oropharynx during spontaneous or controlled ventilation
Other Names:
  • difference in the sevoflurane concentration
Active Comparator: Cuffed tracheal tubes
After tracheal intubation with a cuffed tube, the interventions will be the oxygen concentration, nitrous oxide concentration, carbon dioxide concentration and sevoflurane concentration measured in the tracheal tube compared with those in the oropharynx during spontaneous and controlled ventilation.
Drug: oxygen concentration
oxygen concentration will be measured in the tracheal tube and oropharynx during spontaneous or controlled ventilation
Other Names:
  • difference in the oxygen concentration
Drug: nitrous oxide concentration
nitrous oxide concentration will be measured in the tracheal tube and oropharynx during spontaneous or controlled ventilation
Other Names:
  • difference in the nitrous oxide concentration
Drug: carbon dioxide concentration
carbon dioxide concentration will be measured from the tracheal tube and in the oropharynx during spontaneous or controlled ventilation
Other Names:
  • difference in the carbon dioxide concentration
Drug: sevoflurane concentration
sevoflurane concentration will be measured in the tracheal tube and oropharynx during spontaneous or controlled ventilation
Other Names:
  • difference in the sevoflurane concentration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in the oxygen concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation
Time Frame: 8 months
The differences in the oxygen concentration measured in the trachea and the oropharynx with uncuffed and cuffed tubes during spontaneous or controlled ventilation
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in the nitrous oxide concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation
Time Frame: 8 months
The differences in the nitrous oxide concentration measured in the trachea and the oropharynx with uncuffed and cuffed tubes during spontaneous or controlled ventilation
8 months
Difference in the carbon dioxide concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation
Time Frame: 8 months
The differences in the carbon dioxide concentration measured in the trachea and the oropharynx with uncuffed and cuffed tubes during spontaneous or controlled ventilation
8 months
Difference in the sevoflurane concentration with uncuffed and cuffed tubes during spontaneous or controlled ventilation
Time Frame: 8 months
The differences in the sevoflurane concentration measured in the trachea and the oropharynx with uncuffed and cuffed tubes during spontaneous or controlled ventilation
8 months

Collaborators and Investigators

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

Sponsor

State University of New York at Buffalo

Investigators

  • Principal Investigator: Jerrold Lerman, MD, FRCPC, Women & Children's Hospital of Buffalo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

April 12, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

March 25, 2016

First Submitted That Met QC Criteria

March 30, 2016

First Posted (Estimate)

March 31, 2016

Study Record Updates

Last Update Posted (Actual)

February 13, 2017

Last Update Submitted That Met QC Criteria

February 10, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gas leak during tonsillectomy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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