Cricoid Pressure Versus Paratracheal Pressure

July 27, 2020 updated by: Mhamed Sami Mebazaa, Mongi Slim Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Tunis, Tunisia, 2046
        • Recruiting
        • Mongi Slim Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cricoid pressure group
Patients of this group will recieve cricoid pressure during direct laryngoscopy.
Procedure: cricoid pressure
cricoid pressure during laryngoscopy
Experimental: left paratracheal pressure group
Patients of this group will recieve left paratracheal pressure during direct laryngoscopy.
Procedure: left paratracheal pressure
left paratracheal pressure during laryngoscopy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mongi Slim Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2020

Primary Completion (Anticipated)

September 30, 2020

Study Completion (Anticipated)

November 30, 2020

Study Registration Dates

First Submitted

July 17, 2020

First Submitted That Met QC Criteria

July 17, 2020

First Posted (Actual)

July 22, 2020

Study Record Updates

Last Update Posted (Actual)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 27, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Sellick vs paratracheal

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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