NCT01656967

Brief Summary

The purpose of this study is to compare two types of supraglottic airways (SGA), the Ambu® Aura-I and the Intubating Laryngeal Mask Airway (ILMA), regarding time to intubate, ease of insertion, sealing properties, optical view upon fiberoptic examination regarding the Ambu Aura-I, ease and success rate of intubation, airway morbidity, and patient comfort in patients undergoing general anesthesia for elective surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 3, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

April 22, 2016

Completed
Last Updated

November 8, 2018

Status Verified

October 1, 2018

Enrollment Period

2.5 years

First QC Date

July 30, 2012

Results QC Date

March 22, 2016

Last Update Submit

October 10, 2018

Conditions

Supraglottic Airway

Keywords

Laryngeal Mask AirwayLMAIntubationAMBUAScopeAura-IFastrachFiberopticDisposable FiberopticBlind IntubationFiberoptic Intubation

Outcome Measures

Primary Outcomes (1)

  • Total Intubation Time

    Total Intubation Time includes time for SGA insertion and for ETT insertion. The total time to intubation was measured from the beginning of SGA insertion to successful endotracheal tube intubation verified by detection of CO2 on the capnogram.

    Duration of Intubation, including supraglottic airway (SGA) insertion and endotracheal tube (ETT) insertion

Secondary Outcomes (8)

  • Time for Supraglottic Airway (SGA) Insertion

    At SGA insertion

  • Time for Endotracheal Tube (ETT) Insertion

    At ETT insertion

  • Number of Participants in Whom SGA Insertion Was Successful on the First Attempt

    At SGA insertion

  • Number of Participants in Whom ETT Insertion Was Successful on the First Attempt

    At ETT insertion

  • Number of Participants With Overall Success for SGA Placement

    At SGA insertion

  • +3 more secondary outcomes

Other Outcomes (1)

  • Orolaryngeal Pressure

    Following SGA Insertion

Study Arms (2)

AMBU Aura-I/aScope 2

EXPERIMENTAL

First, the AMBU Aura-I LMA will be inserted. Then, the patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.

Device: AMBU Aura-I/aScope 2

LMA Fastrach

EXPERIMENTAL

The LMA Fastrach Single Use Laryngeal Mask Airway will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.

Device: LMA Fastrach Single Use

Interventions

AMBU Aura-I/aScope 2DEVICE

Once ventilation is achieved, the patients in group A will be intubated through the shaft of Aura-I via the the Ambu aScope.

AMBU Aura-I/aScope 2
LMA Fastrach Single UseDEVICE

The patients in group B will be intubated by ETT via the Intubating LMA as is standard procedure.

LMA Fastrach

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult surgical Candidates Aged 18-80 years
  • ASA I-III
  • Mallampati Score of I or II
  • BMI ≤ 35 kg/m2
  • Presenting for elective surgery
  • Require General Endotracheal Anesthesia.

You may not qualify if:

  • Previously known difficult airway,
  • Emergency status
  • Require prone positioning
  • Interincisor distance \< 2.5cm
  • Thyromental distance \< 5cm
  • Clinically suspected difficult airway
  • Contraindications to LMA Insertion, such as Reflux disease
  • Patients who do not require endotracheal intubation
  • Indications for Rapid Sequence Induction (RSI)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Hermann Hospital - Texas Medical Center

Houston, Texas, 77030, United States

Location

Limitations and Caveats

Experience of the residents, some only had 6 months experience When using AScope, there were secretions and no suctioning capability Sample size ILMA is a straightforward attempt; whereas, AScope needs to maneuver and go all the way to carina

Results Point of Contact

Title
Dr. Carin A. Hagberg
Organization
The University of Texas Health Science Center at Houston
Carin.A.Hagberg@uth.tmc.edu
(713) 500-6240

Study Officials

  • Carin A Hagberg, MD

    The University of Texas Medical School at Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair, Department of Anesthesiology

Study Record Dates

First Submitted

July 30, 2012

First Posted

August 3, 2012

Study Start

July 1, 2010

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

November 8, 2018

Results First Posted

April 22, 2016

Record last verified: 2018-10

Locations

US(1)