Timing of Withdrawal of the Laryngeal Mask Airway (LMA) i... | NCT03105739

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

NCT03105739

Sponsor

Hôpital d'enfants Béchir-Hamza

Status

Completed

Last Update Posted

Apr 10, 2017Actual

Enrollment

148Actual

Phase

Not Applicable

Conditions

Laryngeal Mask Airway Removal
Respiratory Complication

Interventions

LMA removal

Countries

Tunisia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 5, 2016

Primary Completion Date

Mar 29, 2017Actual

Completion Date

Mar 30, 2017Actual

First Submitted Date

Mar 29, 2017

First Submission Date that Met QC Criteria

Apr 3, 2017

First Posted Date

Apr 10, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2017

Last Update Posted Date

Apr 10, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Sonia ben khalifa (PhD), Head of Anesthesia and Intensive Care Department, Hôpital d'enfants Béchir-HamzaPrincipal Investigator

Lead Sponsor

Hôpital d'enfants Béchir-HamzaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

148Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anesthetised	Experimental	LMA removal once the halogenated anesthetic turned off	Other: LMA removal
Awake	Active Comparator	LMA removal once the patient fully regained consciousness	Other: LMA removal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LMA removal	Other	According to randomization, LMA device was removed at the end of surgery, either in deeply anesthetised patients or after consciousness recovery.	Anesthetised

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children scheduled for minor surgery

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sonia Ben Khalifa, PhD		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital d'Enfants Béchir Hamza		Bab Saadoun	Tunis Governorate	1029	Tunisia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided