Cricoid Pressure Versus Paratracheal Pressure

Cricoid Pressure During Tracheal Intubation Clinical Trial

Official title:

Cricoid Pressure Versus Paratracheal Pressure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04481854
• Other study ID #: Sellick vs paratracheal
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: July 2020
• Source: Mongi Slim Hospital
• Contact: Mhamed Sami Mebazaa, professor
• Phone: 0021622252589
• Email: msmebazaa[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cricoid Pressure During Tracheal Intubation

Intervention

Procedure:
• cricoid pressure
cricoid pressure during laryngoscopy
• left paratracheal pressure
left paratracheal pressure during laryngoscopy

Locations

Country	Name	City	State
Tunisia	Mongi Slim Hospital	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Mongi Slim Hospital

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modification of Cormack and Lehane grade	Cormack and Lehane grade before and after the procedure	3 minutes after induction of general anesthesia
Secondary	Effectiveness of the pressure	Possibility to introduce a gastric tube through the oesophagus	5 minutes after induction of general anesthesia