Cricoid Pressure Versus Paratracheal Pressure

NCT ID: NCT04481854

Last Updated: 2020-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-30

Study Completion Date

2020-11-30

Brief Summary

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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

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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.

Conditions

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Cricoid Pressure During Tracheal Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

patients will be randomized to recieve cricoid pressure or left paratracheal pressure
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cricoid pressure group

Patients of this group will recieve cricoid pressure during direct laryngoscopy.

Group Type EXPERIMENTAL

cricoid pressure

Intervention Type PROCEDURE

cricoid pressure during laryngoscopy

left paratracheal pressure group

Patients of this group will recieve left paratracheal pressure during direct laryngoscopy.

Group Type EXPERIMENTAL

left paratracheal pressure

Intervention Type PROCEDURE

left paratracheal pressure during laryngoscopy

Interventions

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cricoid pressure

cricoid pressure during laryngoscopy

Intervention Type PROCEDURE

left paratracheal pressure

left paratracheal pressure during laryngoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mongi Slim Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mhamed Sami Mebazaa

Professor head of the anesthesia and intensive care department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mongi Slim Hospital

Tunis, , Tunisia

Site Status RECRUITING

Countries

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Tunisia

Central Contacts

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Mhamed Sami Mebazaa, professor

Role: CONTACT

0021622252589

Asma Ben Souissi, Ass Prof

Role: CONTACT

0021698336883

Facility Contacts

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Mhamed Sami Mebazaa, professor

Role: primary

0021622252589

Asma Ben Souissi, Ass Prof

Role: backup

0021698336883

Other Identifiers

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Sellick vs paratracheal

Identifier Type: -

Identifier Source: org_study_id

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