NCT06089187

Comparing Endotracheal Tube Cuff Pressure in Laparoscopic Abdominal Surgery: Saline vs. Air Inflation

Completed NA Last updated 13 December 2023

What this trial tests

NA trial testing Endotracheal intubation using an endotracheal tube with cuff inflated with air in Endotracheal Intubation in 60 participants. Completed in 12 December 2023.

Timeline

27 September 2023

Primary endpoint
12 December 2023

12 December 2023

Quick facts

Lead sponsor	Cukurova University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	27 September 2023
Primary completion	12 December 2023
Estimated completion	12 December 2023
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Endotracheal intubation using an endotracheal tube with cuff inflated with air
• Endotracheal intubation using an endotracheal tube with cuff inflated with saline

Conditions studied

• Endotracheal Intubation — all drugs for Endotracheal Intubation →

Sponsor

Cukurova University

Who can join

Adults 18 to 65, any sex, with Endotracheal Intubation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In this study, the investigators aim to compare the incidence of cuff pressure increase between endotracheal tubes inflated with air or saline during elective laparoscopic abdominal surgery under general anesthesia with N2O. This prospective observational study will be conducted on 60 patients aged 18-65 with ASA physical status I-II undergoing elective laparoscopic abdominal surgery under general anesthesia. Patients are randomly assigned to two groups: one group has tubes inflated with air (Group H, n=30), while the other group has tubes inflated with saline (Group S, n=30). The cuff pressure is continuously monitored using a pressure transducer attached to the cuff via a three-way tap. Anesthesia maintenance is achieved with sevoflurane and oxygen/N2O (%40/%60) in both groups. The intervention is performed whenever the cuff pressure exceeds 20 mmHg for \>30 seconds during the CO2 insufflation of the abdomen, and the pressure is reduced. The number of interventions is recorded as the primary outcome of the study. The cuff pressure is measured before and after insufflation and after the patients are placed in Trendelenburg and reverse Trendelenburg positions.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.