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

Assessment of Airway Pressure Changes Using Esophageal Balloon Catheter (OBC) in Patients Undergoing Laparoscopic Surgery Under General Anaesthesia

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.

Study Overview

• Status: Completed
• Conditions: Ventilator Lung
• Intervention / Treatment: Device: Adult esophageal balloon catheter (obc)

Detailed Description

General anaesthesia: Patients will be induced and intubated as per the choice of consultant anaesthetist. Anaesthesia will be maintained with inhalational agent and paralysis maintained with atracurium infusion or bolus so as to keep train of four counts <2 twitches using peripheral nerve stimulator throughout surgery. Conventional ventilation was standardised with mode as pressure control ventilation, pressure inspired targeted to either tidal ventilation of 6-8 ml/kg or end tidal carbon di oxide concentration of 40-50 mmHg and positive end expiratory pressure limited to 5 cm of water. Fraction of inspiratory oxygen was adjusted to keep oxygen saturation > 95%. No recruitment manoeuvres were permitted unless, patient is desaturating actively, and in which case patient will be excluded from the study. Abdominal cavity was insufflated with carbon dioxide with initial high flow and pressure, but later the pressure was maintained at 15cm water.

Esophageal balloon catheter insertion, placement and removal: After applying topical anaesthetic (10% lidocaine spray) to patient's nasopharynx and water-soluble lubricant jelly to distal end of esophageal catheter, it is inserted into patient's esophagus via nasal cavity or oropharyngeal cavity. Estimated depth of catheter insertion is calculated as: patient's height (in cm) X 0.288. Once the esophageal balloon catheter is inserted to estimated depth, balloon is inflated with 4 ml of air and pressure on the stomach is applied to look for positive deflection of oesophageal pressure reading. Once convinced, 2 ml air was taken out and catheter was slowly withdrawn till cardiac oscillations are visible. Occlusion test is performed to confirm the placement of catheter in lower thoracic region. In occlusion test, patient is briefly disconnected from ventilator, endotracheal tube is blocked and pressure is applied on to chest wall. Simultaneous increase in oesophageal balloon pressure and airway pressure is noted. (Change is oesophageal pressure/ change in airway pressure on application of external pressure should be close to 1). Stylet is removed and Oesophageal balloon catheter is secured at this position on nostril or angle of mouth similar to nasogastric tube and connected to pressure transducer to do necessary measurements. Catheter is removed at the end of surgery before extubation after complete deflation of cuff.

Measurements: Soon after confirmation of position, patient is subjected to end inspiratory hold to record the end inspiratory pleural pressure and plateau airway pressure. Patient is then subjected to end expiratory hold to record end expiratory pleural pressure and positive end expiratory pressure. Similar steps are repeated once pneumoperitoneum is achieved and patient is placed in trendelenburg or reverse trendelenburg position and once pneumoperitoneum deflated. Problems encountered during insertion and measurement of esophageal balloon catheter will be resolved using manufacturer's recommendation.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ROHIT V AGRAWAL, MMed, FANZCA; Phone Number: 67744208; Email: rohit_agrawal@nuhs.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore, 119074
    • National University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Interventional arm; Patients recruited will have OBC inserted under general anaesthesia and various pressure measured	Device: Adult esophageal balloon catheter (obc); Using OBC to determine airway pressure changes in patients undergoing general anaesthesia for laparoscopic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National University Hospital, Singapore
• Investigators: Principal Investigator: Rohit V Agrawal, MMed, FANZCA, Consultant, Department of Anaesthesia, NUH

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2018
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: September 19, 2017
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (Actual): January 26, 2018

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: laparoscopic surgery; Airway pressure; Oesophageal pressure; transpulmonary pressure
• Other Study ID Numbers: 2017/00153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Study protocol, results, analysis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No