Ambu AuraGain vs LMA Supreme in Laparoscopic Surgery | NCT02511652

Studies
Ambu AuraGain vs LMA Supreme in Laparoscopic Surgery

NCT02511652

Sponsor

Hospital Clinic of Barcelona

Status

Completed

Last Update Posted

Feb 22, 2016Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Laparoscopy
Airway Management
Supraglottic Airway Devices

Interventions

Ambu AuraGain evaluation
LMA Supreme evaluation
Laparoscopic surgery

Countries

Spain

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

Feb 2016

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

Jun 2015

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Jul 20, 2015

First Submission Date that Met QC Criteria

Jul 28, 2015

First Posted Date

Jul 30, 2015Estimated

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

Feb 19, 2016

Last Update Posted Date

Feb 22, 2016Estimated

Name	Class
Ambu A/S	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 aim of the study is to compare the performance of two supraglottic airway devices (SGA), the new Ambu AuraGain and the LMA Supreme, in sixty female patients undergoing gynaecologic laparoscopy in the trendelemburg position.

Primary outcome is the airway seal pressure. Secondary outcomes are ease of insertion, quality of ventilation, endoscopic view of the glottis, gastric tube passage and complications.

Detailed Description

The patients are randomly assigned to 2 groups:

Group 1: Ambu AuraGain.
Group 2: LMA Supreme, Teleflex

Procedure:

The investigation protocol contains the following sections:

Induction of anaesthesia. Intravenous infusion of remifentanil and propofol targeting the effect site (2-4 ng/ml and 4-6 µg/ml respectively). No muscle relaxant will be used for insertion of the SGA. Rocuronium 0.2 mg/Kg will be administered before initiation of pneumoperitoneum.
Insertion of the SGAs. The size of the SGA device used is based on the manufacturers' recommendations. All devices are deflated a lubricated prior to use. Once inserted, the cuff is be inflated with a manometer up to 60 cm H20 Position of the device is adjusted if needed. Data recorded: size of SGA, time an number of attempts.
Fibreoptic evaluation of the SGAs anatomical position: complete view of the vocal cords (I), epiglottis visible inside, but not causing obstruction (II), epiglottis visible and obstructing the glottic inlet (III), or glottic structures not identified (IV).
Functionality of the gastric drainage channel of the SGAs: passage of a 16 G size tube.
Measurement of airway seal pressure (oropharyngeal leak pressure (OLP): at baseline, and at 15, 30 and 60 minutes. The maximum pressure allowed is 40 cm H2O.
Ventilatory mechanics and parameters are measured at baseline, and at 15, 30 and 60 minutes.

Perioperative complications: Hiccup, gastric distension, regurgitation / Aspiration, airway obstruction, laryngospasm, dental, mucosal or tongue injury, hypoxia (SpO2 < 92%)
Removal of the SGAs: Presence of blood - 3 level grading (+/++/+++) Postoperative complications: sore throat, hoarseness, dysphonia, dysphagia, dysphagia: 3-point scale

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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ambu AuraGain	Active Comparator	Insertion of the supraglottic device and evaluation of its clinical performance	Device: Ambu AuraGain evaluation Procedure: Laparoscopic surgery
LMA Supreme	Active Comparator	Insertion of the supraglottic device and evaluation of its clinical performance	Device: LMA Supreme evaluation Procedure: Laparoscopic surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ambu AuraGain evaluation	Device	Evaluation of clinical performance in terms of Insertion, ventilation, position and complications	Ambu AuraGain

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Airway seal pressure	Maximum airway pressure that the device can achieve without oropharyngeal leak of gas.	At 15 minutes

Secondary Outcomes

Measure	Description	Time Frame
Ease of insertion of the device	Time needed to insert the device	Baseline
Change in Quality of ventilation	number of manoeuvres/corrections required

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients evaluated as eligible for a SGA
ASA I-III
Without criteria for difficult airway
Body Mass Index ≤ 35 kg/m2
The patient has signed the Informed Consent
The patient understands his or hers rights and consequences related to this investigation

Exclusion Criteria:

Planned operation time > 2 hours
High risk of regurgitation
Respiratory tract pathology
Preoperative sore throat
Patients with a known or predicted difficult airway
Patients diagnosed with dementia or any mental handicaps
Patient who has a guardian.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ana M Lopez, MD	Hospital Clinic of Barcelona	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ambulatory Surgery, Hospital Clinic de Barcelona		Barcelona	Barcelona	08036	Spain

Intervention Browse Module

MeSH Terms

ID	Term
D010535	Laparoscopy

Ancestor Terms

ID	Term
D004724	Endoscopy
D003949	Diagnostic Techniques, Surgical
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

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