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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05034666
Other study ID # ETT cuff pressure
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date May 1, 2018

Study information

Verified date August 2021
Source Suez Canal University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Although the increasing uses of different supraglottic devices as an alternative, the traditional endotracheal intubation is still considered the commonly used method for managing the airway of a generally anaesthetized patient. After passing the endotracheal tube through the larynx, the anaesthetist inflates the cuff or asks the anaesthesia technician to inflate it. How much air is injected into the cuff is not a major concern for almost all anaesthetists and they usually depend on palpating the external cuff tense to judge is it too much, accurate or not enough? Cuff pressure is essential in endotracheal tube management. Guidelines recommend a cuff pressure of 20 to 30 cm H2O. Inflation of the cuff of pressure more than 30 cm H2O can damage the tracheal mucosa by compromising capillary perfusion. When pressures are greater than 50 cm H2O, total obstruction of tracheal blood flow occurs. For long times, without any evidence-based data, it has been believed that well-trained anaesthetists are capable of determining proper ETT cuff pressures. It is presumed that anaesthetists can detect appropriate inflation pressure and overinflated ETT cuff by palpating the ETT pilot balloon. Adequacy of cuff inflation is conventionally determined by palpation of the external balloon. Previous studies suggest that this approach is unreliable. One study, for instance, found that cuff pressure exceeded 40 cm H2O in 40-to-90% of tested patients. However, increased awareness of over-inflation risks may have improved recent clinical practice. The aim of the work: This study will investigate the endotracheal cuff inflation pressure applied by the participating anaesthetists, and their response after being informed about the pressure the participants will apply. Material and Methods: Type of the study: Prospective controlled single-blind study. Settings: After obtaining approval by the Ethics Committee of the Suez Canal University Hospital, and written informed consent with an explanation regarding the purpose, effects, technique, and complications, all anaesthetists, working currently in the facility, are included.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date May 1, 2018
Est. primary completion date February 1, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - anaesthetists - works at Suez canal university hospital - resident, registrar, or senior registrar Exclusion Criteria: - refusal to participate - who will not complete the 2 rounds 3 readings each

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Suez Canal University Ismailia

Sponsors (1)

Lead Sponsor Collaborator
Suez Canal University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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