NCT05034666

Brief Summary

Cuff pressure is essential in endotracheal tube management. Guidelines recommend a cuff pressure of 20 to 30 cm H2O. One study, for instance, found that cuff pressure exceeded 40 cm H2O in 40-to-90% of tested patients. This study will investigate the endotracheal ETT cuff inflation pressure applied by the participating anaesthetists, and their response after being informed about the pressure the participants will apply.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 1, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
Last Updated

September 5, 2021

Status Verified

August 1, 2021

Enrollment Period

1 month

First QC Date

August 25, 2021

Last Update Submit

August 29, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • accuracy in inflating the cuff of the endotracheal tubes

    assessment of the Anesthetists' accuracy in inflating the cuff of the endotracheal tubes used to maintain the airway of generally anaesthetized patients the change following feedback.

    immediately after fixation of the endotracheal tube during general anaethesia

Study Arms (2)

Before education

ACTIVE COMPARATOR

Before alarming the participant anaesthetists about the pressure values of their practice in inflating the ETT cuff. This is before applying the intervention which is informing and educating the participant anaesthetists about the proper ETT cuff pressure.

Behavioral: Before the education program

After education

ACTIVE COMPARATOR

After alarming the participant anaesthetists about the pressure values of their practice in inflating the ETT cuff. This is after applying the intervention which is informing and educating the participant anaesthetists about the proper ETT cuff pressure.

Behavioral: After the education program

Interventions

Before applying the education program of the endotracheal cuff pressure inflation to the participating anaesthetists.

Before education

After applying the education program of the endotracheal cuff pressure inflation to the participating anaesthetists.

After education

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • anaesthetists
  • works at Suez canal university hospital
  • resident, registrar, or senior registrar

You may not qualify if:

  • refusal to participate
  • who will not complete the 2 rounds 3 readings each

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suez Canal University

Ismailia, 2685, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
the participants are not informed about the visit, and the investigator is measuring the ETT cuff pressure in the absence of the participant.
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: anaesthetists of anaesthesia department on Suez canal university
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia and intensive care

Study Record Dates

First Submitted

August 25, 2021

First Posted

September 5, 2021

Study Start

January 1, 2018

Primary Completion

February 1, 2018

Study Completion

May 1, 2018

Last Updated

September 5, 2021

Record last verified: 2021-08

Locations