Airway Management in Children Undergoing Adenotonsillectomies

NCT00570414 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2009-01-15

No results posted yet for this study

Summary

Secure airway management is the basis of all anesthesiological practice. Of particular importance is the securing of patients' airway passages when the surgical procedure itself poses a threat to a patient's airway, as is the case in all procedures involving the upper respiratory pathways. When adenoidectomies, tonsillectomies and combined adenotonsillectomies are performed, blood from the surgical area will present a respiratory threat to unsecured airways. The traditional opinion has been that endotracheal intubation is the safest method of preventing aspiration.

The laryngeal mask was introduced in 1983 as an alternative to the endotracheal tube. In 1990, the flexible, reinforced laryngeal mask airway was introduced, intended for use during surgical procedures involving the mouth and throat. The laryngeal mask airway has several potential advantages over the endotracheal tube. It is inserted blindly, without laryngoscopy. This leads to reduced oropharyngeal or laryngeal stimulation and injury, and therefore minimal activation of respiratory and circulatory reflexes. The laryngeal mask airway can be placed without the use of muscle relaxants, avoiding potential side effects such as apnea, hyperkalemia and anaphylaxis. In addition the laryngeal mask airway can remain in the throat until the patient awakes, virtually eliminating the danger of postoperative aspiration.

Several international studies have described the advantages of the laryngeal mask airway over endotracheal intubation during ear, nose and throat surgery in children. The general impression is that there is a widespread routine implementation of the laryngeal mask airway. In Norway, however, this practice has been limited. As far as we know, only Namsos Hospital uses this procedure as its first choice. At Telemark Hospital we tested the use of laryngeal mask airway on 150 patients between May and December 2006. The results so far have been promising, and we have had no serious complications.

Hypothesis:

In children undergoing adenotonsillectomies, a laryngeal mask airway provides greater patient satisfaction (judged by reduced pain, nausea and vomiting) and greater effectivity (judged by reduced time in surgery), compared with the endotracheal tube. The laryngeal mask provides as much as or greater secure airway management measured by desaturations/Sp02\<92% and/or use of suxamethonium and bronchiolytic drugs.

Conditions

  • Tonsillitis

Interventions

DEVICE

Laryngeal mask airway

Airway management by the use of the flexible, reinforced laryngeal mask airway

DEVICE

Endotracheal tube

Airway management by the use of endotracheal tube

Sponsors & Collaborators

  • Sykehuset Telemark

    lead OTHER_GOV

Principal Investigators

  • Simen Doksrød, MD · Sykehuset Telemark

  • Peter Heidt, PhD · Namsos Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00570414 on ClinicalTrials.gov