Cricoid Pressure Versus Paratracheal Pressure | NCT04481854

Studies
Cricoid Pressure Versus Paratracheal Pressure

NCT04481854

Sponsor

Mongi Slim Hospital

Status

Unknown status

Last Update Posted

Jul 29, 2020Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Cricoid Pressure During Tracheal Intubation

Interventions

cricoid pressure
left paratracheal pressure

Countries

Tunisia

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 2020

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

Jan 30, 2020Actual

Primary Completion Date

Sep 30, 2020Estimated

Completion Date

Nov 30, 2020Estimated

First Submitted Date

Jul 17, 2020

First Submission Date that Met QC Criteria

Jul 17, 2020

First Posted Date

Jul 22, 2020Actual

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 27, 2020

Last Update Posted Date

Jul 29, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mhamed Sami Mebazaa, Professor head of the 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

Prospective randomized trial, including adult patients scheduled for orthopedic or abdominal surgery under general anesthesia and tracheal intubation. in this study the investigators will compare the classic cricoid pressure and the left paratracheal pressure regarding their impact on the intubation condition and the effectiveness.

Detailed Description

During the laryngoscopy, the modification of the Cormack and Lehane grade before and after the application of the cricoid or paratracheal pressure will be noticed.

concerning the effectiveness of the procedure, a gastric tube will be introduced through the oesophagus during the procedure, under direct vision.

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cricoid pressure group	Experimental	Patients of this group will recieve cricoid pressure during direct laryngoscopy.	Procedure: cricoid pressure
left paratracheal pressure group	Experimental	Patients of this group will recieve left paratracheal pressure during direct laryngoscopy.	Procedure: left paratracheal pressure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cricoid pressure	Procedure	cricoid pressure during laryngoscopy	Cricoid pressure group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Modification of Cormack and Lehane grade	Cormack and Lehane grade before and after the procedure	3 minutes after induction of general anesthesia

Secondary Outcomes

Measure	Description	Time Frame
Effectiveness of the pressure	Possibility to introduce a gastric tube through the oesophagus	5 minutes after induction of general anesthesia

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult patients with no criteria of difficult intubation or mask ventilation
no criteria of full stomach requiring crush induction

Exclusion Criteria:

Unexpected difficult laryngoscopy or mask ventilation

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mhamed Sami Mebazaa, professor	Contact	0021622252589		msmebazaa@gmail.com
Asma Ben Souissi, Ass Prof	Contact	0021698336883		bsouissiasma@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mongi Slim Hospital	Recruiting	Tunis		2046	Tunisia

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