CPAP on Oxygenation and Pulmonary Function in Elderly Patients After Major Open Abdominal Surgery (CPAP)

February 12, 2024 updated by: Nguyen Dang Thu

Comparison of Continuous Positive Airway Pressure Modes (Constant Via Facial Mask vs. Auto Via Nasal Mask) on Oxygenation and Pulmonary Function in Elderly Patients After Major Open Abdominal Surgery

Postoperative continuous positive airway pressure (CPAP) can improve lung function. The risk of pulmonary complications is high after major abdominal surgery but may be reduced by prophylactic postoperative noninvasive ventilation using CPAP. This study compared the effects of auto-CPAP via a nasal mask (JPAP) and constant-CPAP via a facial mask (O2-Max Trio) on oxygenation and pulmonary function in elderly patients after major open abdominal surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After being informed about the study and potential risks, all patients giving written informed consent will undergo screening period to determine eligibility for study entry.

Patients aged over 60 years, scheduled for major open abdominal surgery (i.e., gastrectomy, colectomy, proctocolectomy, or abdominal aortic aneurysm repair).

All patients received standardized anesthetic management following the established protocols of our hospital. Before induction, an epidural catheter was placed in the epidural space at thoracic T7-9 level for upper abdominal surgery and at lumbaric L1-3 level for lower abdominal surgery. A 0.2% bupivacaine solution was administered with a 5 ml bolus dosage, maintained at 5 ml/h during surgery, and the infusion rate was adjusted for pain management until postoperative day 3. General anesthesia was induced using propofol, fentanyl, and rocuronium, with maintenance using sevoflurane. Neuromuscular blockade was monitored using the train-of-four (TOF) stimulation. Fentanyl and epidural infusion rates were adjusted to maintain the Surgical Pleth Index (SPI) in the range of 40-70. Extubation was only performed when the TOF ratio was > 90%.

In the PACU, after extubation, all patients lay on their backs with a backrest tilted to 45 degrees. Postoperative pain was assessed using a numeric rating scale (NRS; 0-10) and treated with epidural boluses or IV opioids if pain exceeded NRS 3 at rest or NRS 5 during movement. Acute pain, nausea, or circulatory problems were managed and ruled out. CPAP was administered when patients were conscious and had the ability to cough and expectorate phlegm.

Patients were randomly assigned in a 1:1 ratio to either the O2-Max Trio or JPAP group through a computer-generated randomization list.

Patients in the O2-Max Trio group received CPAP via the O2-Max Trio CPAP system (Pulmodyne, Indianapolis, USA) with a facial mask that was adjusted to maintain a CPAP at 7.5 cm H2O and FiO2 30% continuously for the following 1 h.

JPAP group patients connected to the JPAP system (Metran, Saitama, Japan) via a nasal mask with the initial CPAP 2 cmH2O, then reach CPAP 7.5 cmH2O after a ramping time of 5 minutes.

Discharge from the PACU was according to a modified Aldrete discharge score. The criteria for discharge from the PACU were hemodynamic stability, SpO2 .90% with FIO2,0.4, absence of clinical signs of respiratory distress, full consciousness, and sufficient diuresis (>0.3 ml/kg/h).

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Hanoi, Vietnam, 12108
        • VietXo Friendship Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient agrees to participate in the study
  • Age 60 or older
  • ASA I, II, III
  • Patients underwent open abdominal surgery under general anesthesia, and extubation without complications

Exclusion Criteria:

  • Upper airway deformities
  • Significant bullous emphysema
  • Bronchopleural fistula
  • Facial deformation
  • Non-epidural anesthesia
  • Hemodynamic unstable
  • Inability to provide consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Auto-CPAP via nasal mask
Patients connected to the JPAP system (Metran, Saitama, Japan) via a nasal mask with the initial CPAP 2 cmH2O, then reach CPAP 7.5 cmH2O after a ramping time of 5 minutes.
Device: Auto CPAP via nasal mask (JPAP machine)
Auto Continuous Positive Airway Pressure via nasal mask using the JPAP system (Metran, Saitama, Japan) which can provide CPAP with a range of 2-10 cmH2O, the initial CPAP 2 cmH2O, then reach 7.5 cmH2O after a ramping time. CPAP values may vary with each breath until the obstruction is resolved
Active Comparator: Constant-CPAP via facial mask
Patients connected to the O2-Max Trio CPAP system (Pulmodyne, Indianapolis, USA) with a facial mask and maintained a CPAP at 7.5 cm H2O
Device: Constant CPAP via facial mask (O2-Max Trio system)
Patients connected to the O2-Max Trio CPAP system (Pulmodyne, Indianapolis, USA) with a facial mask that was adjusted to maintain a CPAP at 7.5 cm H2O and FiO2 30% continuously for the following 1 hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The oxygenation-PaO2/FiO2
Time Frame: Three time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAP
The partial pressure of oxygen in arterial blood (PaO2)/fraction of inspired oxygen (FIO2) ratio. PaO2 was measured by drawing 2 mL of blood from the radial artery and using a Cobas B221 blood gas analyzer (Roche, Basel, Switzerland), whereas the FIO2 was read from the CPAP apparatus.
Three time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAP

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The forced vital capacity (FVC)
Time Frame: Three time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAP
Forced vital capacity (FVC) was evaluated by spirometry test. The parameter was measured with Spirobank II Advanced (Medical International Research, Roma, Italia)
Three time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAP
The forced expiratory volume in the first second-FEV1
Time Frame: Three time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAP

The forced expiratory volume in the first second-FEV1 was evaluated by spirometry test.

The parameter was measured with Spirobank II Advanced (Medical International Research, Roma, Italia)
Three time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAP
The FEV1/FVC ratio
Time Frame: Three time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAP
The FEV1/FVC ratio was evaluated by spirometry test. The parameter was measured with Spirobank II Advanced (Medical International Research, Roma, Italia)
Three time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAP
The peak expiratory flow-PEF
Time Frame: Three time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAP
The peak expiratory flow-PEF was evaluated by spirometry test. The parameter was measured with Spirobank II Advanced (Medical International Research, Roma, Italia)
Three time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nguyen Dang Thu

Investigators

  • Principal Investigator: Thu Nguyen Dang, Vietnam Military Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

August 20, 2022

Study Completion (Actual)

August 30, 2022

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Estimated)

February 15, 2024

Study Record Updates

Last Update Posted (Estimated)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3977/QĐ-HVQY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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