Cricoid Pressure Versus Paratracheal Pressure

Not Applicable

• Conditions: Cricoid Pressure During Tracheal Intubation
• Interventions: Procedure: left paratracheal pressure; Procedure: cricoid pressure

• Registration Number: NCT04481854
• Lead Sponsor: Mongi Slim Hospital

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

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 Timeline

• Study Start: 2020-01-30
• Status Verified: 2020-07
• Study First Submitted: 2020-07-17
• Study First Submitted QC: 2020-07-17
• Study First Posted: 2020-07-22
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-29
• Primary Completion: 2020-09-30
• Study Completion: 2020-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
left paratracheal pressure group	left paratracheal pressure	Patients of this group will recieve left paratracheal pressure during direct laryngoscopy.
Cricoid pressure group	cricoid pressure	Patients of this group will recieve cricoid pressure during direct laryngoscopy.

Primary Outcome Measures

Name	Time	Method
Modification of Cormack and Lehane grade	3 minutes after induction of general anesthesia	Cormack and Lehane grade before and after the procedure

Secondary Outcome Measures

Name	Time	Method
Effectiveness of the pressure	5 minutes after induction of general anesthesia	Possibility to introduce a gastric tube through the oesophagus

Trial Locations

Locations (1)

Mongi Slim Hospital; 🇹🇳 Tunis, Tunisia