Airway Management in Children Undergoing Adenotonsillectomies

NCT00570414 | Completed DMC

• 2 other identifiers: s8197.03s-07031b
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction: a) Pain (VAS, use of opioids), b) Nausea and vomiting (score)

  24 hrs

Secondary Outcomes (2)

• Effectivity (judged by reduced time in surgery)

  1 hrs

• Secure airway management measured by desaturations/Sp02<92% and/or use of suxamethonium and bronchiolytic drugs.

  24 hrs

Study Arms (2)

1

ACTIVE COMPARATOR

Laryngeal mask airway (LMA)

Device: Laryngeal mask airway

2

ACTIVE COMPARATOR

Endotracheal tube (ETT)

Device: Endotracheal tube

Interventions

Laryngeal mask airway DEVICE

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

1

Endotracheal tube DEVICE

Airway management by the use of endotracheal tube

2

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• ASA III or higher.
• Weight \< 10 kg or weight \> 60 kg.
• Congenital malformations of the mouth or throat.

Sponsors & Collaborators

• Sykehuset Telemark: lead

Study Sites (1)

Sykehuset Telemark, Clinic of emergency medicin

Porsgrunn, Telemark, 3913, Norway

Location

MeSH Terms

Conditions

Tonsillitis

Interventions

Laryngeal Masks

Condition Hierarchy (Ancestors)

Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Simen Doksrød, MD

  Sykehuset Telemark

  PRINCIPAL INVESTIGATOR

• Peter Heidt, PhD

  Namsos Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: December 10, 2007
• First Posted: December 11, 2007
• Study Start: March 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: January 15, 2009

Record last verified: 2009-01

Locations

NO (1)