Macintosh Versus Macgrath for Laryngoscopy in COVID 19 Hy... | NCT04956913

Studies
Macintosh Versus Macgrath for Laryngoscopy in COVID 19 Hypoxemic ICU Patients

NCT04956913

Sponsor

Mongi Slim Hospital

Status

Unknown status

Last Update Posted

Jul 9, 2021Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

COVID-19 Acute Respiratory Distress Syndrome

Interventions

Mac Grath
Macintosh

Countries

Not provided

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

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2021Estimated

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Jan 31, 2022Estimated

First Submitted Date

Jul 8, 2021

First Submission Date that Met QC Criteria

Jul 8, 2021

First Posted Date

Jul 9, 2021Actual

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

Jul 8, 2021

Last Update Posted Date

Jul 9, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mhamed Sami Mebazaa, Professor head of anesthesia and intensive care department, Mongi Slim HospitalPrincipal Investigator

Lead Sponsor

Mongi Slim HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

In this comparative prospective study, we aim to compare the classic Macintosh laryngoscope and the Mac Grath videolaryncoscope in ICU covid 19 patients recruiting intubation and invasive mechanical ventilation.

patients meeting inclusion criteria were randomized in 2 groups: MacGrath and Macintosh.

we collected anthropometric and intubation data among all patients, and the 2 groups were compared regarding the time for intubation, the need of alternative techniques to intubate and the impact on the oxygenation by recording the lowest SPO2.

Detailed Description

All hypoxemic COVID19 patients requiring intubation were enrolled in this trial.

all patients had a preoxygenation with non invasive ventilation with 100% oxygen.

patients meeting inclusion criteria were randomized in 2 groups: MacGrath and Macintosh.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mac Grath		Patients of this group were intubated using Mac Gath videolaryngoscope	Device: Mac Grath
Machintosh		Patients of this group were intubated using the classic Macintosh laryngscoscope	Device: Macintosh

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mac Grath	Device	Patients of this group were intubated using Mac Gath videolaryngoscope	Mac Grath

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time for tracheal intubation	Time from the blade pass the lips until the first breath was administred	10 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All COVID 19 hypoxemic patients requiring tracheal intubation

Exclusion Criteria:

hypoxemic cardiac arrest before intubation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

ICU covid 19 patients requiring tracheal intubation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mhamed Mebazaa, Professor	Contact	0021622252589		msmebazaa@gmail.com
Asma Ben Souissi, asso prof	Contact	0021698336883		bsouissiasma@gmail.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided