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

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ClinicalTrials.gov Identifier: NCT03411239
Recruitment Status : Recruiting
First Posted : January 26, 2018
Last Update Posted : October 12, 2021
Sponsor:
Information provided by (Responsible Party):
National University Hospital, Singapore

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ventilator Lung Device: Adult esophageal balloon catheter (obc) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Airway Pressure Changes Using Esophageal Balloon Catheter (OBC) in Patients Undergoing Laparoscopic Surgery Under General Anaesthesia
Actual Study Start Date : March 8, 2018
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Inspiratory and expiratory oesophageal pressure during laparoscopic surgery [ Time Frame: 1 year ]
    using pressure monitoring line

  2. Inspiratory and expiratory transpulmonary pressure during laparoscopic surgery [ Time Frame: 1 year ]
    difference between oesophageal pressure and airway pressures

  3. Inspiratory and expiratory transpulmonary pressure during supine, trendelenburg and reverse trendelenburg position [ Time Frame: 1 year ]
    difference between esophageal pressure and airway pressure in various positions


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03411239


Contacts
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Contact: ROHIT V AGRAWAL, MMed, FANZCA 67744208 rohit_agrawal@nuhs.edu.sg

Locations
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Singapore
National University Health System Recruiting
Singapore, Singapore, 119074
Contact: Lian K Ti, MBBS, MMed    +65 67723134    lian_kah_ti@nuhs.edu.sg   
Principal Investigator: Lian K Ti, MBBS, MMed         
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
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Principal Investigator: Rohit V Agrawal, MMed, FANZCA Consultant, Department of Anaesthesia, NUH
More Information
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Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT03411239    
Other Study ID Numbers: 2017/00153
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: October 12, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Study protocol, results, analysis

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National University Hospital, Singapore:
Airway pressure
Oesophageal pressure
transpulmonary pressure
laparoscopic surgery