Investigation of Endotracheal Cuff Pressure Changes According to Different Positions in Neurosurgery Cases

Not yet recruiting

• Conditions: The Effect of Cuff Pressure on Postoperative Dysphagia
• Interventions: Other: supine position; Other: prone position; Other: semi-fowler position

• Registration Number: NCT05712135
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

We aimed to measure the change in cuff pressure in different positions in neurosurgery cases and to investigate the effect of case length on cuff pressure.

Detailed Description

It is an observational study, the cuffs of the endotracheal tubes of the patients who were intubated under general anesthesia between February 2023 and May 2023 will be inflated at 25 cm H2O pressure, and then the pressure line and the pilot balloon will be connected to the anesthesia monitor. The cuff pressure of the patient will be measured from the pilot balloon throughout the case and recorded at half-hour intervals. Postoperative sore throat will be evaluated on the VAS scale. Postoperative cough, hoarseness, and dysphagia symptoms will be evaluated.

Study Timeline

• Study First Submitted: 2022-11-27
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-25
• Last Update Submitted: 2023-01-25
• Study Start: 2023-02-01
• Study First Posted: 2023-02-03
• Last Update Posted: 2023-02-03
• Primary Completion: 2023-05-02
• Study Completion: 2023-06-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

• Neurosurgery patients between the ages of 18-70 ages
• American Society of Anesthesiologist score I-II-III-IV

Exclusion Criteria

• Patients with previous tracheostomy
• Patients with tracheal stenosis
• Patients considered as difficult intubation
• Patients who have had more than one intubation attempt
• Patients with an ASA score greater than 4
• Patient who has difficulty understanding visual analog scale (VAS) scores
• Language / communication barrier
• Patients younger than 18 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
supine	supine position	The patient group whose cuff pressure was measured in the supine position in neurosurgery
prone	prone position	The patient group whose cuff pressure was measured in the prone position in neurosurgery
semi-fowler	semi-fowler position	The patient group whose cuff pressure was measured in the semi-fowler position in neurosurgery

Primary Outcome Measures

Name	Time	Method
The effect of cuff pressure on postoperative sore throat	24 hours	The primary outcome of the study was intubated under general anesthesia, endotracheal cuff of patients in supine, prone, semi-fowler position is to observe the change of pressures according to the positions.

Secondary Outcome Measures

Name	Time	Method
Comparison of cuff pressure changes with cuff time according to groups	8 hours	Secondary outcome of the study, case length on endotracheal cuff pressure is to observe.