NCT03045835

Brief Summary

Baska mask is a new novel supraglottic airway device with many salient features. The investigators aim to determine the benefit of BASKA mask as an effective airway device for laparoscopic surgery, and whether it can even substitute endotracheal intubation, in order to smoothen the surgery and anaesthesia process as well as reduce perioperative complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

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

First Submitted

Initial submission to the registry

January 25, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 8, 2017

Completed
21 days until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

1.5 years

First QC Date

January 25, 2017

Last Update Submit

July 5, 2020

Conditions

Laparoscopic Surgery

Keywords

laparoscopic cholecystectomy BASKA mask Endotracheal tube

Outcome Measures

Primary Outcomes (1)

  • Time to effective airway insertion

    defined as time from picking up the airway device (either BASKA mask or Endotracheal tube), insertion and until occurrence of the first square-waveform capnogram

    1 hour

Secondary Outcomes (4)

  • Numbers of attempt of airway device insertion and Ease of insertion

    1 hour

  • Gastric distension scoring by surgeon

    during operative duration

  • Post operation incidence of complications

    from the induction of anaesthesia, until at the postanaesthetic care unit (PACU), assessed up to 24 hours

  • Hemodynamic changes

    after induction of anaesthesia at 1, 2, 3,4,5,10,20,30 minutes; then post extubation at 1 ,2,3,4,5 minutes

Other Outcomes (2)

  • oropharyngeal leak pressure (OPL) of the device during operation

    during operative duration

  • peak airway pressure of the device during operation

    during operative duration

Study Arms (2)

BASKA mask

EXPERIMENTAL

Selection of size : size 3 (30-50kg), size 4 (50-70kg), size 5 (70-100kg)

Device: BASKA mask

Endotracheal intubation

ACTIVE COMPARATOR

Selection of size : ID 7.0-7.5mm (women), ID 7.5-8.0mm (men)

Device: Endotracheal intubation

Interventions

BASKA maskDEVICE

Baska mask will be inserted during induction of anaesthesia and once patient is in an adequate anaesthetic depth

BASKA mask
Endotracheal intubationDEVICE

Endotracheal intubation will be carried out during induction of anaesthesia and once patient is in an adequate anaesthetic depth

Endotracheal intubation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 75 years old
  • American Society of Anesthesiologists (ASA) physical status I and II BMI ≤ 35
  • Laparoscopic cholecystectomy only

You may not qualify if:

  • Known gastroesophageal reflux
  • History of difficult intubation or difficult anaesthesia
  • Features of facial, laryngeal and pharyngeal anatomy problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Malaya Medical Centre

Petaling Jaya, Selangor, 59100, Malaysia

Location

Related Publications (1)

  • Ng CC, Sybil Shah MHB, Chaw SH, Mansor MB, Tan WK, Koong JK, Wang CY. Baska mask versus endotracheal tube in laparoscopic cholecystectomy surgery: a prospective randomized trial. Expert Rev Med Devices. 2021 Feb;18(2):203-210. doi: 10.1080/17434440.2021.1865796. Epub 2020 Dec 31.

    PMID: 33322949DERIVED

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsIntubationInvestigative Techniques

Study Officials

  • CHING CHOE NG, MMED(ANAES)

    UNIVERSITY OF MALAYA MEDICAL CENTRE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MMED (Anaes)

Study Record Dates

First Submitted

January 25, 2017

First Posted

February 8, 2017

Study Start

March 1, 2017

Primary Completion

August 31, 2018

Study Completion

March 31, 2019

Last Updated

July 7, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)