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

NCT05712135 | Unknown

• 1 other identifier: E2-22-1369
• Study Type: observational
• Target: 165
• Locations: 0 countries
• Sites: N/A

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.

Conditions

The Effect of Cuff Pressure on Postoperative Dysphagia

Keywords

cuff pressure; postoperative dysphagia; different positions in neurosurgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comparison of cuff pressure changes with cuff time according to groups

  8 hours

Study Arms (3)

supine

The patient group whose cuff pressure was measured in the supine position in neurosurgery

Other: supine position

prone

The patient group whose cuff pressure was measured in the prone position in neurosurgery

Other: prone position

semi-fowler

The patient group whose cuff pressure was measured in the semi-fowler position in neurosurgery

Other: semi-fowler position

Interventions

supine position OTHER

The patient group whose cuff pressure was measured in the supine position

supine

prone position OTHER

The patient group whose cuff pressure was measured in the prone position

prone

semi-fowler position OTHER

The patient group whose cuff pressure was measured in the semi-fowler position

semi-fowler

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

MeSH Terms

Interventions

Supine Position; Prone Position

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Sena Sarıcaoglu Oktem, Resident

CONTACT

+90 538 600 2190; senasaricaoglu@gmail.com

Mehmet Sahap, Specialist

CONTACT

+90 533 682 6254; drsahap@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant doctor

Study Record Dates

• First Submitted: November 27, 2022
• First Posted: February 3, 2023
• Study Start: February 1, 2023
• Primary Completion: May 2, 2023
• Study Completion: June 2, 2023
• Last Updated: February 3, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share