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Airway Management in Children Undergoing Adenotonsillectomies

Primary Purpose

Tonsillitis

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Laryngeal mask airway
Endotracheal tube
Sponsored by
Sykehuset Telemark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tonsillitis

Eligibility Criteria

3 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sykehuset Telemark, Clinic of emergency medicin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Laryngeal mask airway (LMA)

Endotracheal tube (ETT)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Effectivity (judged by reduced time in surgery)
Secure airway management measured by desaturations/Sp02<92% and/or use of suxamethonium and bronchiolytic drugs.

Full Information

First Posted
December 10, 2007
Last Updated
January 14, 2009
Sponsor
Sykehuset Telemark
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1. Study Identification

Unique Protocol Identification Number
NCT00570414
Brief Title
Airway Management in Children Undergoing Adenotonsillectomies
Official Title
Airway Management in Children Undergoing Adenotonsillectomies Under General Anesthesia; a Comparison of the Endotracheal Tube and the Laryngeal Mask Airway
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sykehuset Telemark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tonsillitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Laryngeal mask airway (LMA)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Endotracheal tube (ETT)
Intervention Type
Device
Intervention Name(s)
Laryngeal mask airway
Intervention Description
Airway management by the use of the flexible, reinforced laryngeal mask airway
Intervention Type
Device
Intervention Name(s)
Endotracheal tube
Intervention Description
Airway management by the use of endotracheal tube
Primary Outcome Measure Information:
Title
Patient satisfaction: a) Pain (VAS, use of opioids), b) Nausea and vomiting (score)
Time Frame
24 hrs
Secondary Outcome Measure Information:
Title
Effectivity (judged by reduced time in surgery)
Time Frame
1 hrs
Title
Secure airway management measured by desaturations/Sp02<92% and/or use of suxamethonium and bronchiolytic drugs.
Time Frame
24 hrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simen Doksrød, MD
Organizational Affiliation
Sykehuset Telemark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Heidt, PhD
Organizational Affiliation
Namsos Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Sykehuset Telemark, Clinic of emergency medicin
City
Porsgrunn
State/Province
Telemark
ZIP/Postal Code
3913
Country
Norway

12. IPD Sharing Statement

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Airway Management in Children Undergoing Adenotonsillectomies

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