NCT06058481

Brief Summary

Patients aged 19 to 78 years with ASA status I-II scheduled for elective surgery under general anesthesia, were recruited and randomized into two groups, Group A (BlockBuster) and Group B (Proseal-LMA). Anesthesia induction for both groups was standardized with no paralysis given. Supraglottic airway (SGA) insertion (either Blockbuster or Proseal-LMA) was executed by a single experienced investigator. The investigator inserted the BlockBuster in Group A patients and the Proseal-LMA in Group B patients. These parameters were compared between the groups; the number of attempts, time taken to achieve successful insertion, oropharyngeal leak pressure (OLP), fiberoptic view of SGA position, hemodynamics changes and complications from the insertion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

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 31, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

September 12, 2023

Last Update Submit

September 21, 2023

Conditions

Supraglottic Airway Device

Outcome Measures

Primary Outcomes (1)

  • Oropharyngeal leak pressure measurement to assess efficacy of airway seal by the supraglottic airway device

    Oropharyngeal leak pressure (OLP) was assessed by setting the adjustable pressure-limiting (APL) valve of the circle system at 30 cmH2O with a fresh gas flow of 3L/min. The OLP was determined by observing the airway pressure at equilibrium until an audible noise was heard over the mouth with a stethoscope. The measurement unit is cmH2O. For safety reasons, the OLP was kept below 40 cmH2O.

    1 year

Secondary Outcomes (3)

  • First pass success rate

    1 year

  • Number of supraglottic airway insertion attempt

    1 year

  • Supraglottic airway insertion time

    1 year

Other Outcomes (4)

  • Position of supraglottic airway device after insertion

    1 year

  • Mean arterial pressure during supraglottic airway insertion

    1 year

  • Heart rate during supraglottic airway insertion

    1 year

  • +1 more other outcomes

Study Arms (2)

Group A

EXPERIMENTAL

The investigator inserted the BlockBuster (supraglottic airway device) in Group A patients after induction of anaesthesia.

Device: Blockbuster

Group B

ACTIVE COMPARATOR

The investigator inserted the Proseal-LMA (supraglottic airway device) in Group B patients after induction of anaesthesia.

Device: Proseal-LMA

Interventions

BlockbusterDEVICE

The investigator inserted the BlockBuster in Group A patients.

Group A
Proseal-LMADEVICE

The investigator inserted the Proseal-LMA in Group B patients.

Group B

Eligibility Criteria

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

You may qualify if:

  • age range of 19 to 78 years
  • classified as American Society of Anesthesiologists Physical Status (ASA) class I or II
  • underwent elective surgery under general anesthesia that required supraglottic airway insertion.

You may not qualify if:

  • patients with a body mass index (BMI) over 35 kg/m2.
  • patients with limited mouth opening of less than two finger breath of inter-dental gap, edentulous, loose teeth and airway abnormalities.
  • patients who at risk of aspiration.
  • patients with known allergies to fentanyl and propofol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Study Officials

  • Maryam Budiman, M.D.

    Faculty of Medicine, Universiti Kebangsaan Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2023

First Posted

September 28, 2023

Study Start

July 31, 2019

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)