NCT04481854

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

8 months

First QC Date

July 17, 2020

Last Update Submit

July 27, 2020

Conditions

Cricoid Pressure During Tracheal Intubation

Keywords

cricoid pressureparatracheal pressure

Outcome Measures

Primary Outcomes (1)

  • Modification of Cormack and Lehane grade

    Cormack and Lehane grade before and after the procedure

    3 minutes after induction of general anesthesia

Secondary Outcomes (1)

  • Effectiveness of the pressure

    5 minutes after induction of general anesthesia

Study Arms (2)

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

cricoid pressurePROCEDURE

cricoid pressure during laryngoscopy

Cricoid pressure group
left paratracheal pressurePROCEDURE

left paratracheal pressure during laryngoscopy

left paratracheal pressure group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Unexpected difficult laryngoscopy or mask ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mongi Slim Hospital

Tunis, 2046, Tunisia

RECRUITING

Central Study Contacts

Mhamed Sami Mebazaa, professor

CONTACT

0021622252589msmebazaa@gmail.com

Asma Ben Souissi, Ass Prof

CONTACT

0021698336883bsouissiasma@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: patients will be randomized to recieve cricoid pressure or left paratracheal pressure
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor head of the anesthesia and intensive care department

Study Record Dates

First Submitted

July 17, 2020

First Posted

July 22, 2020

Study Start

January 30, 2020

Primary Completion

September 30, 2020

Study Completion

November 30, 2020

Last Updated

July 29, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)