Airway Management in Children Undergoing Adenotonsillectomies

This study has been completed.
Sponsor:
Information provided by:
Sykehuset Telemark
ClinicalTrials.gov Identifier:
NCT00570414
First received: December 10, 2007
Last updated: January 14, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention
Tonsillitis
Device: Laryngeal mask airway
Device: Endotracheal tube

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Airway Management in Children Undergoing Adenotonsillectomies Under General Anesthesia; a Comparison of the Endotracheal Tube and the Laryngeal Mask Airway

Resource links provided by NLM:


Further study details as provided by Sykehuset Telemark:

Primary Outcome Measures:
  • Patient satisfaction: a) Pain (VAS, use of opioids), b) Nausea and vomiting (score) [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effectivity (judged by reduced time in surgery) [ Time Frame: 1 hrs ] [ Designated as safety issue: No ]
  • Secure airway management measured by desaturations/Sp02<92% and/or use of suxamethonium and bronchiolytic drugs. [ Time Frame: 24 hrs ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 128
Study Start Date: March 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Laryngeal mask airway (LMA)
Device: Laryngeal mask airway
Airway management by the use of the flexible, reinforced laryngeal mask airway
Active Comparator: 2
Endotracheal tube (ETT)
Device: Endotracheal tube
Airway management by the use of endotracheal tube

Detailed Description:

Registration:

Preoperative: Age, height, weight, medication, asthma/allergy, possible current respiratory infection

Peroperative: Type of procedure, tube size/laryngeal mask, type of tongue blade, highest/lowest SpO2, highest/lowest ET CO2, highest/lowest pulse, length of surgery, total operating room time, operator, medication. Reason must be given if converting from laryngeal mask to tube; lack of visibility for operator, laryngeal mask not possible to place, unacceptable leakage before placing tongue blade, occlusion after placement of tongue blade.

Postoperative: Pain judged by need for opiates (VAS, crying, agitation, tachycardia), nausea judged by gagging/vomiting, total time in recovery, rebleeding judged by reoperation.

Anesthesia:

Induction: Alfentanil 20 microg/kg body weight Propofol 3-4 mg/kg body weight Or: Sevoflurane/N2O mask induction with MAC 1-2

Maintenance: Alfentanil 5-10 microg/kg body weight every 8-10 minutes Sevoflurane/N2O equivalent to 1-1.5 MAC Acetaminophen supp 40 mg/kg body weight, max 2 g. Dexamethasone 0.15mg/kg body weight Xylocaine 1mg/kg body weight

Emergence: Morphine 100-200 mikrog/kg body weight

Postoperative: Morphine 50-100 microg/kg body weight

Post-discharge: Acetaminophen tbl 15 mg/kg body weight x 3 Or: Acetaminophen supp 20 mg/kg body weight x 3

Patient booklet:

A patient booklet will be produced for each patient. The booklet will contain only the patient's initials, age and research number. After the booklets are filled out, they will be stored in a locked facility by one of the examining physicians, and the code to the patient's name will be stored and locked separately by one of the researchers. The code will be destroyed at the end of the research study.

  Eligibility

Ages Eligible for Study:   3 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children 10-60 kg
  • Elective adenotomy, tonsillectomy or combined adenotonsillectomy under general anesthesia.
  • Written and oral informed parental consent.

Exclusion Criteria:

  • ASA III or higher.
  • Weight < 10 kg or weight > 60 kg.
  • Congenital malformations of the mouth or throat.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570414

Locations
Norway
Sykehuset Telemark, Clinic of emergency medicin
Porsgrunn, Telemark, Norway, 3913
Sponsors and Collaborators
Sykehuset Telemark
Investigators
Principal Investigator: Simen Doksrød, MD Sykehuset Telemark
Study Director: Peter Heidt, PhD Namsos Hospital
  More Information

No publications provided

Responsible Party: Simen Doksrød, Sykehuset Telemark
ClinicalTrials.gov Identifier: NCT00570414     History of Changes
Other Study ID Numbers: s8197.03, s-07031b
Study First Received: December 10, 2007
Last Updated: January 14, 2009
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services
Norway: Directorate of Health

Additional relevant MeSH terms:
Tonsillitis
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on April 22, 2014