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

NCT ID: NCT05013658

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-08
• Study Completion Date: 2021-09-01

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.

Conditions

Endotracheal Tube Cuff Pressure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

junior

their anesthesia experiences are between 1 months and 1 year,

Group Type: ACTIVE_COMPARATOR

pressure measurement

Intervention Type: BEHAVIORAL

pressure measurement with pilot balloon palpation

senior

Their anesthesia experiences are more than 4 years

Group Type: ACTIVE_COMPARATOR

pressure measurement

Intervention Type: BEHAVIORAL

pressure measurement with pilot balloon palpation

Interventions

pressure measurement

pressure measurement with pilot balloon palpation

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kocaeli University

OTHER

Sponsor Role: lead

Responsible Party

Tülay Çardaközü

professor Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

TÜLAY ÇARDAKÖZÜ

Role: PRINCIPAL_INVESTIGATOR

KOCAELİ ÜNİVERSİTESİ

Locations

Kocaeli Üniversitesi

Kocaeli, Kocaeli̇, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

manometer1

Identifier Type: -

Identifier Source: org_study_id