NCT03140215

Brief Summary

The study aimed to compare safety of the 3rd generation Supra-glottic airway device (SAD) "Baska" to the I-Gel , regarding seal pressure, fitting on the larynx (detected by Fiberoptic) \& complications. The study will be done for females undergoing minor gynecological procedures under general anesthesia with spontaneous ventilation.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Status
unknown

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

First Submitted

Initial submission to the registry

January 8, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

6 months

First QC Date

January 8, 2016

Last Update Submit

May 2, 2017

Conditions

Medical Device Complication

Keywords

Baskaseal pressureI-GelSupraglottic airway device

Outcome Measures

Primary Outcomes (1)

  • seal pressure

    Airway Sealing Pressure in cmH2O at 5 mins postplacement.The airway sealing pressure was the pressure at which leak starts. This leak pressure was calculated as the plateau airway pressure reached with fresh gas flow 6 l/min, and pressure adjustment valve set at 70 cmH2O..

    seal pressure will be assessed 3minutes after induction of general anesthesia.

Secondary Outcomes (3)

  • Fiberoptic view of the larynx.

    Fiberoptic view will be assessed 5 minutes after induction of anesthesia.

  • Peak airway pressure in CmH2O

    during the operation the operation

  • incidence of vomiting and regurgitation

    from the start of operation till 10 minutes postoperative

Study Arms (2)

Baska Device ventilation group

ACTIVE COMPARATOR

Device: laryngeal mask insertion (Baska)

Device: laryngeal mask insertion (Baska)Device: laryngeal mask insertion (I-gel )

I-Gel device ventilation group

ACTIVE COMPARATOR

Device: laryngeal mask insertion ( I-gel )

Device: laryngeal mask insertion (Baska)Device: laryngeal mask insertion (I-gel )

Interventions

laryngeal mask insertion (Baska)DEVICE
Also known as: Baska
Baska Device ventilation groupI-Gel device ventilation group
laryngeal mask insertion (I-gel )DEVICE
Also known as: I-gel
Baska Device ventilation groupI-Gel device ventilation group

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female ASA1,2
  • Age 18-55
  • BMI\<35

You may not qualify if:

  • Anticipated upper airway problem
  • GIT disease
  • Pregnancy
  • High risk of aspiration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Nesrine A. El-Refai, M.D

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 8, 2016

First Posted

May 4, 2017

Study Start

June 1, 2016

Primary Completion

December 1, 2016

Study Completion

August 1, 2017

Last Updated

May 4, 2017

Record last verified: 2017-05