Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 16 of 576 for:    CARBON DIOXIDE AND anesthesia

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02725164
Recruitment Status : Completed
First Posted : March 31, 2016
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
Jerrold Lerman, State University of New York at Buffalo

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Exposure to Environmental Pollution Adverse Effect of Unspecified General Anesthetic Drug: oxygen concentration Drug: nitrous oxide concentration Drug: carbon dioxide concentration Drug: sevoflurane concentration Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Anesthetic Gas Leakage in Children During Tonsillectomy: a Comparison of Cuffed and Uncuffed Tracheal Tubes
Actual Study Start Date : April 12, 2016
Actual Primary Completion Date : June 1, 2016
Actual Study Completion Date : June 1, 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: difference in the sevoflurane concentration




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02725164


Sponsors and Collaborators
State University of New York at Buffalo
Investigators
Layout table for investigator information
Principal Investigator: Jerrold Lerman, MD, FRCPC Women & Children's Hospital of Buffalo

Publications:
Layout table for additonal information
Responsible Party: Jerrold Lerman, Clinical Professor of Anesthesia, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT02725164     History of Changes
Other Study ID Numbers: Gas leak during tonsillectomy
First Posted: March 31, 2016    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Jerrold Lerman, State University of New York at Buffalo:
oxygen
nitrous oxide
sevoflurane
carbon dioxide
endotracheal tube
respiration
Additional relevant MeSH terms:
Layout table for MeSH terms
Anesthetics
Anesthetics, Inhalation
Anesthetics, General
Nitrous Oxide
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents