Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05013658 |
| Other study ID # |
manometer1 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 8, 2021 |
| Est. completion date |
September 1, 2021 |
Study information
| Verified date |
August 2021 |
| Source |
Kocaeli University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In routine practice, pressure is often attempted to be adjusted by palpation of the cuff
pilot balloon of the endotracheal tube. The aim of our study is to investigate the variation
of the reliability of the palpation method, which is widely used in cuff pressure measurement
in the absence of a manometer, with clinical experience. Our recommendation is to use an
accessible manometer if available.
Description:
After the patients were premedicated with an appropriate dose of midazolam, anesthesia was
induced with propofol, fentanyl and rocuronium. Endotracheal intubation was performed after
ensuring appropriate anaesthesia depth for intubation, by relaxation of the jaw and loss of
eyelash reflex. We used 7.5 and 8.0 sizes of sterile ETTs are made of polyvinyl chloride and
have a high-volume low-pressure cuffed design that conforms to the shape of the trachea. ETTs
for female and male patients and before intubation Tracheal tubes (Tyco Healthcare©, Wollerau
Switzerland) cuffs were tested for leakage. The researchers were divided into two groups of
20, with anaesthesia residents (anesthesia experience between 1 months and 1 year, Group J)
and those with more than 4 years (Group S). The ETT was placed using the conventional
intubation technique with a Macintosh laryngoscope after ensuring appropriate anaesthesia
depth for intubation, by relaxation of the jaw and loss of eyelash reflex.. It was asked to
swell with air up to cmH2O and a 10 ml injector was used for this. Then Direct pressure
measurement was achieved by a cuff manometer calibrated in cmH2O, which was attached to the
ETT pilot balloon. The participant was not informed about the actual pressure of cuff. Then
the air in the cuff was completely evacuated and the same procedure was repeated with the
participant from the other group, the agreement of the two groups to the target value of 25
cmH2O was compared. The order of priority among the groups was randomized according to the
closed-envelope method. Controlled positive pressure ventilation was started after the
measurement.
In cases in which the cuff pressure was above 30 cmH2O or below 20 cmH2O, the pressure was
regulated back to normal limits. During the study, patients were in a supine, head and neck
neutral position. Anesthesia was maintained as in our routine clinical practice.
