Comparison Between McGrath and Macintosh Laryngoscopes fo... | NCT05988736

Studies
Comparison Between McGrath and Macintosh Laryngoscopes for DLT Intubation in Thoracic Surgery Patients.

NCT05988736

Sponsor

Aga Khan University

Status

Unknown status

Last Update Posted

Aug 14, 2023Actual

Enrollment

84Estimated

Phase

Not Applicable

Conditions

Thoracic Diseases
Thoracic Neoplasms
Thoracic Empyema

Interventions

MaCintosh Laryngoscope (DL)
McGrath Laryngoscope (VL)

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2022Actual

Primary Completion Date

Dec 1, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Jul 27, 2023

First Submission Date that Met QC Criteria

Aug 9, 2023

First Posted Date

Aug 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2023

Last Update Posted Date

Aug 14, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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,

Rate of successful intubation at first attempt and
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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

84Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental		Device: MaCintosh Laryngoscope (DL)
Group B	Active Comparator		Device: McGrath Laryngoscope (VL)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MaCintosh Laryngoscope (DL)	Device	A conventional Laryngoscope. It is battery powered, with a detachable MaCintosh blade that contains a light source.	Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
sadique Wadho, MBBS	Contact	+923322792932		sadique.ali@aku.edu
Khalid Samad, MBBS, FCPS	Contact	+923343311603		khalid.samad@aku.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aga Khan University Hospital	Recruiting	Karachi	Sindh		Pakistan

Condition Browse Module

MeSH Terms

ID	Term
D013896	Thoracic Diseases
D013899	Thoracic Neoplasms
D016724	Empyema, Pleural

Ancestor Terms

ID	Term
D012140	Respiratory Tract Diseases
D009371	Neoplasms by Site
D009369	Neoplasms
D012141	Respiratory Tract Infections

Browse Leaves

Not provided

Browse Branches

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