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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: The Effect of Cuff Pressure on Postoperative Dysphagia
• Intervention / Treatment: Other: supine position; Other: prone position; Other: semi-fowler position

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 Type: Observational
• Enrollment (Anticipated): 165

Contacts and Locations

• Study Contact: Name: Sena Sarıcaoglu Oktem, Resident; Phone Number: +90 538 600 2190; Email: senasaricaoglu@gmail.com
• Study Contact Backup: Name: Mehmet Sahap, Specialist; Phone Number: +90 533 682 6254; Email: drsahap@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Neurosurgery patients between the ages of 18-70 under general anesthesia in the operating room between February 2022 and April 2022.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
supine; The patient group whose cuff pressure was measured in the supine position in neurosurgery	Other: supine position; The patient group whose cuff pressure was measured in the supine position
prone; The patient group whose cuff pressure was measured in the prone position in neurosurgery	Other: prone position; The patient group whose cuff pressure was measured in the prone position
semi-fowler; The patient group whose cuff pressure was measured in the semi-fowler position in neurosurgery	Other: semi-fowler position; The patient group whose cuff pressure was measured in the semi-fowler position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of cuff pressure on postoperative sore throat	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.	24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2023
• Primary Completion (ANTICIPATED): May 2, 2023
• Study Completion (ANTICIPATED): June 2, 2023

Study Registration Dates

• First Submitted: November 27, 2022
• First Submitted That Met QC Criteria: January 25, 2023
• First Posted (ACTUAL): February 3, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 3, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: cuff pressure; postoperative dysphagia; different positions in neurosurgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: E2-22-1369

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No