Timing of Withdrawal of the Laryngeal Mask Airway (LMA) in Children

Timing of Withdrawal of the Laryngeal Mask Airway (LMA) in Children: Early or Late Removal?

The purpose of this prospective, randomized study was to compare the incidence of adverse events associated with removal of the LMA either in deeply anesthetised or awake patients.

Study Overview

• Status: Completed
• Conditions: Respiratory Complication; Laryngeal Mask Airway Removal
• Intervention / Treatment: Other: LMA removal

Detailed Description

Written informed consent was obtained from parents for this prospective, randomized study conducted on children scheduled for minor surgery. Anesthesia was induced with sevoflurane, supplemented with propofol (3mg/kg) then maintained with nitrous oxide and sevoflurane 2-4% in oxygen. Analgesia was insured by peripheral nerve blocks. Included children were randomized into 2 groups:

• Awake: the LMA was left in place until the patient fully regained consciousness
• Deeply anesthetised: the LMA was immediately removed once the halogenated anesthetic turned off, and ventilation using facial mask was carried until spontaneous ventilation recovery.

Respiratory complications that occurred during LMA removal until 20 minutes afterwards were recorded. Children with respiratory history and those for whom peripheral nerve blocks failed, were excluded.

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • Tunis
    • Bab Saadoun, Tunis, Tunisia, 1029
      • Hopital d'Enfants Bechir Hamza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children scheduled for minor surgery

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anesthetised; LMA removal once the halogenated anesthetic turned off	Other: LMA removal; According to randomization, LMA device was removed at the end of surgery, either in deeply anesthetised patients or after consciousness recovery.
Active Comparator: Awake; LMA removal once the patient fully regained consciousness	Other: LMA removal; According to randomization, LMA device was removed at the end of surgery, either in deeply anesthetised patients or after consciousness recovery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurence of respiratory adverse events	from LMA removal to 20 minutes afterwards

Collaborators and Investigators

• Sponsor: Hôpital d'enfants Béchir-Hamza
• Investigators: Principal Investigator: Sonia Ben Khalifa, PhD

Study record dates

Study Major Dates

• Study Start: October 5, 2016
• Primary Completion (Actual): March 29, 2017
• Study Completion (Actual): March 30, 2017

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: April 3, 2017
• First Posted (Actual): April 10, 2017

Study Record Updates

• Last Update Posted (Actual): April 10, 2017
• Last Update Submitted That Met QC Criteria: April 3, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: LMA-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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