Airway Pressure Changes Using Esophageal Balloon Catheter (OBC) in Laparoscopic Surgery

NCT03411239 | Completed DMC

• 1 other identifier: 2017/00153
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single centre study. The investigators intend to recruit 20 subjects over 4 months. Patients undergoing laparoscopic abdominal surgery for cholecystectomy, laparoscopic gynaecological surgery and laparoscopic urologic procedures either as day surgery, same day admission or in patients, will be included in the study. Patients will be identified at the time of listing for surgery and referred to study team, which in turn will recruit the patients. Informed consent will be obtained at the time of recruitment and a copy of consent with details of principal investigator would be provided to subjects. All data collection will be done intraoperative. Patient would be followed up once at day 3 post op period. If patients have any complications related to the study, they will be followed up weekly until the complication is resolved.

Conditions

Ventilator Lung

Keywords

Airway pressure; Oesophageal pressure; transpulmonary pressure; laparoscopic surgery

Outcome Measures

Primary Outcomes (3)

• Inspiratory and expiratory oesophageal pressure during laparoscopic surgery

  using pressure monitoring line

  1 year

• Inspiratory and expiratory transpulmonary pressure during laparoscopic surgery

  difference between oesophageal pressure and airway pressures

  1 year

• Inspiratory and expiratory transpulmonary pressure during supine, trendelenburg and reverse trendelenburg position

  difference between esophageal pressure and airway pressure in various positions

  1 year

Study Arms (1)

Interventional arm

OTHER

Patients recruited will have OBC inserted under general anaesthesia and various pressure measured

Device: Adult esophageal balloon catheter (obc)

Interventions

Adult esophageal balloon catheter (obc) DEVICE

Using OBC to determine airway pressure changes in patients undergoing general anaesthesia for laparoscopic surgery

Interventional arm

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA grade 1 and 2 patients,
• Age \> 21 yrs.
• Elective intraabdominal laparoscopic surgery

You may not qualify if:

• ASA grade 3 and 4 patients
• Emergency surgery
• Patient with tracheostomy
• Patient with any oropharyngeal pathology
• Patients with co-existing respiratory disease i.e. COPD, restrictive lung disease.
• Patients with oesophageal diseases: varicose, stricture, recent esophageal or gastric surgery.
• Patients with nasopharyngeal diseases: sinusitis, epistaxis, nasopharyngeal carcinoma post radiotherapy or chemotherapy.
• Age \< 21 years
• Pregnant females

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Health System

Singapore, 119074, Singapore

Location

Study Officials

• Rohit V Agrawal, MMed, FANZCA

  Consultant, Department of Anaesthesia, NUH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: January 26, 2018
• Study Start: March 8, 2018
• Primary Completion: April 30, 2022
• Study Completion: September 30, 2022
• Last Updated: July 27, 2023

Record last verified: 2021-10

Locations

SG (1)