NCT05988736

Brief Summary

The goal of this RCT is to compare outcome with McGrath vs Macintosh laryngoscopes among patients undergoing thoracic surgery. The main questions it aims to answer are,

  1. 1.Rate of successful intubation at first attempt and
  2. 2.Time for intubation required with each device. Participants are required to sign the informed consent for, they will be placed in two groups, Group A: Macintosh (DL) Group B: McGrath (VL) Researchers will compare in Group A: Macintosh (DL) and Group B: McGrath (VL) the differences in rate of successful intubation at first attempt and time for intubation required with each device.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

June 15, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

1.5 years

First QC Date

July 27, 2023

Last Update Submit

August 9, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Time required for correct placement of the Double Lumen Tube (DLT).

    Time will be measured in seconds during laryngoscopy while placement of Double Lumen Tube (DLT) until appearance of end tidal carbon dioxide on capnograph.

    During intervention time period

  • Successful Intubation at first attempt.

    The number of times the laryngoscope will be inserted.

    immediately after Intervention.

Study Arms (2)

Group A

EXPERIMENTAL
Device: MaCintosh Laryngoscope (DL)

Group B

ACTIVE COMPARATOR
Device: McGrath Laryngoscope (VL)

Interventions

A conventional Laryngoscope. It is battery powered, with a detachable MaCintosh blade that contains a light source.

Group A

A video Laryngoscope that has a high-resolution video camera, and a light source at the cone end of the blade allowing for direct and indirect viewing of the glottis

Group B

Eligibility Criteria

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

You may qualify if:

  • Age 18-65 years
  • American Society of Anaesthesiologists physical status (ASA) I, II, III
  • Elective thoracic surgery patients, requiring one lung ventilation.

You may not qualify if:

  • Patients requiring rapid sequence induction
  • Patients with a structural problem in the airway on chest radiography
  • History of difficult intubation
  • Planned tracheostomy \\ the presence of a tracheostomy
  • Patients with a BMI \>35 kg\\m2. Who at risk of regurgitation\\ Aspiration
  • Anticipated Difficult Airway (Mallampati IV)
  • Pre-existing sore throat or hoarseness, or recent respiratory infection (\<15 days)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, Pakistan

RECRUITING

MeSH Terms

Conditions

Thoracic DiseasesThoracic NeoplasmsEmpyema, Pleural

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesNeoplasms by SiteNeoplasmsRespiratory Tract InfectionsInfectionsEmpyemaSuppurationPleural DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

sadique Wadho, MBBS

CONTACT

Khalid Samad, MBBS, FCPS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 27, 2023

First Posted

August 14, 2023

Study Start

June 15, 2022

Primary Completion

December 1, 2023

Study Completion

December 31, 2023

Last Updated

August 14, 2023

Record last verified: 2023-08

Locations