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Comparison of the Predictions of ETTcP With Pilot Balloon Palpation Among Anaesthesia Residents in Different Years

Comparison of the Predictions of Endotracheal Tube Cuff Pressure With Pilot Balloon Palpation and the Value Measured by Manometer Among Anaesthesia Residents in Different Education Years in the Department of Anesthesiology and Reanimation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05013658
Acronym
ETTcP
Enrollment
75
Registered
2021-08-19
Start date
2021-01-08
Completion date
2021-09-01
Last updated
2025-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endotracheal Tube Cuff Pressure

Brief 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.

Detailed 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.

Interventions

pressure measurement with pilot balloon palpation

Sponsors

Kocaeli University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. Patients undergo elective operations with general anesthesia. 2. Ages between 18-75 3. ASA I-II-III patients

Exclusion criteria

1. Patient refusal 2. Patients with anticipated difficult airway \- Tempero-mandibular and atlanto-occipitac joint limitation 3. Having ejection fraction less than 35% 4. Peroperative nasogastric tube inserted patients 5. Patients with a history of sore throat, hoarseness, difficulty swallowing before the operation

Design outcomes

Primary

MeasureTime frameDescription
experience differencefour monthsAfter intubation, first the assistant doctor with 0-1 year training period and then the assistant doctor with 4-5 years training period will be asked to inflate the cuff to approximately 25 cm H2O cuff pressure by palpation, and the pressure will be measured with a manometer and recorded.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026