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.