Factors Affecting Endotracheal Cuff Pressure in Gynecological Cases

NCT04466995 | Completed DMC

• 1 other identifier: 2020/92
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative airway complications associated with endotracheal intubation can be seen. While some of these complications are predictable, some may occur urgently. If the endotracheal cuff is over-inflated and its pressure is high, mucosal damage resulting from mucosal pressure is one of the main factors for tracheal morbidity. Endotracheal tube cuff pressure is not routinely measured. It was confirmed that the palpation of the pilot balloon was insufficient to detect high cuff pressures. In laparoscopic cases, the investigators aimed to investigate whether the increase in intra-abdominal pressure as a result of carbon dioxide insufflation, and the change of respiratory functions after trendelenburg position are effective on cuff pressure and whether there is a difference compared to laparotomic cases.

Conditions

Intubation Complication

Outcome Measures

Primary Outcomes (1)

• cuff pressure

  cuff pressure to be measured with manometer

  1 hour

Study Arms (2)

laparoscopic gynecologic surgery

EXPERIMENTAL

25 laparoscopic surgery to endotracheal cuff pressure 5., 15., 30., 45. min will be measured, values will be recorded

Device: manometer

laparotomic gynecologic surgery

OTHER

25 laparotomic surgery to endotracheal cuff pressure 5., 15., 30., 45. min will be measured, values will be recorded

Device: manometer

Interventions

manometer DEVICE

cuff pressure to be measured with manometer

laparoscopic gynecologic surgery; laparotomic gynecologic surgery

Eligibility Criteria

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

You may qualify if:

• Female patients between 18-70 years old who will undergo gynecological abdominal surgery
• Patients with American Society of Anesthesiologists physical status 1-3
• Patients who will undergo elective surgery

You may not qualify if:

• Patients with tracheotomy
• Patients with detected tracheal stenosis
• Patients with laryngeal disease or laryngeal surgery
• Patients with difficult airway (intubated after 2 or more attempts)
• Patients with BMI\> 35
• Patients receiving chronic obstructive pulmonary disease treatment
• Patients with ASA ≥4

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Istanbul, Bakirkoy, Turkey (Türkiye)

Location

Study Officials

• gunes o yildiz

  Bakırkoy Dr. Sadi Konuk Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Endotracheal tube pressure will be measured in the surgical technique using 2 different methods.(laparoscopic and laprotomic)

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: July 10, 2020
• Study Start: February 5, 2020
• Primary Completion: January 1, 2021
• Study Completion: June 1, 2021
• Last Updated: February 1, 2022

Record last verified: 2022-01

Locations

TU (1)