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

NCT06089187 | Completed

• 1 other identifier: ETTSVA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endotracheal Intubation

Outcome Measures

Primary Outcomes (1)

• The number of intervention

  The number of interventions required to correct intracuff pressure

  15 minutes

Secondary Outcomes (1)

• Peak Airway pressure

  15 minutes

Study Arms (2)

Saline Group

ACTIVE COMPARATOR

Anesthesia machine's APL valve will be adjusted to a pressure of 20 cmH20, and during ventilation with a balloon, the endotracheal tube cuffs will be inflated with saline in such a way that there will be no leakage sound from the patient's mouth.

Procedure: Endotracheal intubation using an endotracheal tube with cuff inflated with saline

Air Group

PLACEBO COMPARATOR

Anesthesia machine's APL valve will be adjusted to a pressure of 20 cmH20, and during ventilation with a balloon, the endotracheal tube cuffs will be inflated with air in such a way that there will be no leakage sound from the patient's mouth.

Procedure: Endotracheal intubation using an endotracheal tube with cuff inflated with air

Interventions

Endotracheal intubation using an endotracheal tube with cuff inflated with air PROCEDURE

After endotracheal intubation, the endotracheal tube cuff is inflated with air

Air Group

Endotracheal intubation using an endotracheal tube with cuff inflated with saline PROCEDURE

After endotracheal intubation, the endotracheal tube cuff is inflated with saline

Saline Group

Eligibility Criteria

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

You may qualify if:

• aged 18-65,
• American Society of Anesthesiologists physical status 1 or 2
• Expected surgery time of 30-120 minutes,
• Scheduled for elective laparoscopic abdominal surgery

You may not qualify if:

• neuropsychiatric disease
• muscle disease
• serious cardiovascular and respiratory system disease
• upper respiratory tract infection in the last 14 days
• morbid obesity
• alcohol or substance addiction
• history of bronchospasm
• expectation of difficult intubation
• history of tracheostomy
• history of laryngeal disease or surgery.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Department of Anesthesiology, Cukurova University Faculty of Medicine

Adana, 01130, Turkey (Türkiye)

Location

Related Publications (1)

• Armstrong J, Jenner P, Poulose S, Moppett IK. The effect of saline versus air for cuff inflation on the incidence of high intra-cuff pressure in paediatric MicroCuff(R) tracheal tubes: a randomised controlled trial. Anaesthesia. 2021 Nov;76(11):1504-1510. doi: 10.1111/anae.15493. Epub 2021 Apr 23.

  PMID: 33891328 BACKGROUND

MeSH Terms

Interventions

Air; Sodium Chloride

Intervention Hierarchy (Ancestors)

Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Prospective randomized controlled study

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 18, 2023
• Study Start: September 27, 2023
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)