Supreme Versus Proseal Laryngeal Mask Airways in Infants | NCT03251105

Studies
Supreme Versus Proseal Laryngeal Mask Airways in Infants

NCT03251105

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Status

Completed

Last Update Posted

Aug 16, 2017Actual

Enrollment

120Actual

Phase

Not Applicable

Conditions

Surgery
Infant Conditions
Anesthesia

Interventions

supraglottic airway intubation

Countries

Not provided

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

Aug 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

Apr 27, 2016Actual

Primary Completion Date

Dec 31, 2016Actual

Completion Date

Jan 31, 2017Actual

First Submitted Date

Aug 7, 2017

First Submission Date that Met QC Criteria

Aug 11, 2017

First Posted Date

Aug 16, 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

Aug 11, 2017

Last Update Posted Date

Aug 16, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Canan Tulay ISIL, Specialist, M.D., Sisli Hamidiye Etfal Training and Research HospitalPrincipal Investigator

Lead Sponsor

Sisli Hamidiye Etfal Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

In this study, the Supreme and ProSeal LMAs in infants were compared by measuring their performance characteristics, including insertion features, ventilation parameters, induced changes in hemodynamics and rates of postoperative complications.

Detailed Description

Both the Supreme™ and ProSeal™ laryngeal mask airways (LMAs) are widely used for paediatric anaesthesia; however, LMA use in infants is limited, as many anaesthesiologists prefer to use tracheal intubation in infants.

Infants of ASA physical status I who were scheduled for elective, minor, lower abdominal surgery were divided into two groups: the Supreme LMA group and the ProSeal LMA group. Heart rate (HR), oxygen saturation and end tidal carbon dioxide values were recorded both before and after LMA insertion, as well as both before and after extubation. After extubation, complications and adverse effects were noted.

Demographics and surgical data were similar between the two groups. LMA insertion times for the ProSeal group were shorter, the leakage pressure for the ProSeal group was statistically higher. The ProSeal LMA is superior to the Supreme LMA for use in infants, due to its ease of insertion, high oropharyngeal leakage pressure and fewer induced changes in hemodynamics.

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

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ProSeal group	Active Comparator	This group received the ProSeal LMA for supraglottic airway intubation and ventilation during anaesthesia.	Device: supraglottic airway intubation
Supreme group	Active Comparator	This group received the Supreme LMA for supraglottic airway intubation and ventilation during anaesthesia.	Device: supraglottic airway intubation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
supraglottic airway intubation	Device		ProSeal group Supreme group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
performance characteristics	insertion time in minutes	operation duration

Secondary Outcomes

Measure	Description	Time Frame
haemodynamics	end tidal CO2 (EtCO2) in mmHg	operation duration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

scheduled for elective, minor (<1 hour duration), lower abdominal surgery, including unilateral herniorrhaphy and unilateral orchidopexy

Exclusion Criteria:

premature birth, potentially difficult airway, clinically significant upper respiratory tract infection and risk of aspiration, such as gastro-oesophageal reflux disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

12 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sibel Oba, MD	Sisli Hamidiye Etfal Training and Research Hospital	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25074619	Background	Luce V, Harkouk H, Brasher C, Michelet D, Hilly J, Maesani M, Diallo T, Mangalsuren N, Nivoche Y, Dahmani S. Supraglottic airway devices vs tracheal intubation in children: a quantitative meta-analysis of respiratory complications. Paediatr Anaesth. 2014 Oct;24(10):1088-98. doi: 10.1111/pan.12495. Epub 2014 Jul 30.
28870163	Derived