Monitoring Changes in Endotracheal Tube Cuff Pressure During Laparoscopic Bariatric Surgery

NCT06738875 | Recruiting

• 1 other identifier: HTONER
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational cohort study was designed to assess the relationship between ETT cuff pressures and airway pressures in obese patients undergoing laparoscopic bariatric surgery. We hypothesized that the ETT cuff pressures will rise in direct relationship to increases in the peak and mean airway pressures.

Conditions

Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

• ETT cuff pressure

  ETT cuff pressure

  1-immediately after intubation; 2-after intraperitoneal insufflation; 3-after the position is given 4-after peritoneal exsufflation

Secondary Outcomes (1)

• Peak airway pressures

  1-immediately after intubation; 2-after intraperitoneal insufflation; 3-after the position is given 4-after peritoneal exsufflation

Interventions

manometre DEVICE

Increases in peak and mean airway pressures of ETT cuff pressures will be monitored in patients undergoing laparoscopic bariatric surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

28

You may qualify if:

• American Society of Anesthesiologists (ASA) risk indicators I-III manage to undergo Laparoscopic bariatric surgery between the ages of 18-70

You may not qualify if:

• Patients with drug allergies, chronic pain, long-term opioid use, history of psychiatric illness, and need for emergency surgery were excluded from the study.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital: lead

Study Sites (1)

Health Sciences University Gazi Yaşargil Training and Research Hospital

Kayapınar, Di̇yarbakir, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Prospective Observational Study

Central Study Contacts

Hülya Tosun Söner, doktor

CONTACT

+905352792102; hulyatosunsoner@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 18, 2024
• Study Start: December 10, 2024
• Primary Completion: January 10, 2025
• Study Completion: January 15, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)