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

NCT06260826 | Completed DMC

• 1 other identifier: 3977/QĐ-HVQY
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Continuous Positive Airway Pressure; Pulmonary Function; Older People

Keywords

Continuous Positive Airway Pressure; Pulmonary Function; Elderly patients; Abdominal open surgery

Outcome Measures

Primary Outcomes (1)

• The oxygenation-PaO2/FiO2

  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 Outcomes (4)

• The forced vital capacity (FVC)

  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

  Three time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAP

• The FEV1/FVC ratio

  Three time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAP

• The peak expiratory flow-PEF

  Three time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAP

Study Arms (2)

Auto-CPAP via nasal mask

EXPERIMENTAL

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)

Constant-CPAP via facial mask

ACTIVE COMPARATOR

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)

Interventions

Auto CPAP via nasal mask (JPAP machine) DEVICE

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

Auto-CPAP via nasal mask

Constant CPAP via facial mask (O2-Max Trio system) DEVICE

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

Constant-CPAP via facial mask

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Nguyen Dang Thu: lead

Study Sites (1)

VietXo Friendship Hospital

Hanoi, 12108, Vietnam

Location

Related Publications (7)

• Osterkamp JTF, Strandby RB, Henningsen L, Marcussen KV, Thomsen T, Mortensen CR, Achiam MP, Jans O. Comparing the effects of continuous positive airway pressure via mask or helmet interface on oxygenation and pulmonary complications after major abdominal surgery: a randomized trial. J Clin Monit Comput. 2023 Feb;37(1):63-70. doi: 10.1007/s10877-022-00857-7. Epub 2022 Apr 16.

  PMID: 35429325 BACKGROUND

• Garutti I, Puente-Maestu L, Laso J, Sevilla R, Ferrando A, Frias I, Reyes A, Ojeda E, Gonzalez-Aragoneses F. Comparison of gas exchange after lung resection with a Boussignac CPAP or Venturi mask. Br J Anaesth. 2014 May;112(5):929-35. doi: 10.1093/bja/aet477. Epub 2014 Feb 3.

  PMID: 24496783 BACKGROUND

• Ireland CJ, Chapman TM, Mathew SF, Herbison GP, Zacharias M. Continuous positive airway pressure (CPAP) during the postoperative period for prevention of postoperative morbidity and mortality following major abdominal surgery. Cochrane Database Syst Rev. 2014 Aug 1;2014(8):CD008930. doi: 10.1002/14651858.CD008930.pub2.

  PMID: 25081420 BACKGROUND

• Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.

  PMID: 28186222 BACKGROUND

• Abbott TEF, Fowler AJ, Pelosi P, Gama de Abreu M, Moller AM, Canet J, Creagh-Brown B, Mythen M, Gin T, Lalu MM, Futier E, Grocott MP, Schultz MJ, Pearse RM; StEP-COMPAC Group. A systematic review and consensus definitions for standardised end-points in perioperative medicine: pulmonary complications. Br J Anaesth. 2018 May;120(5):1066-1079. doi: 10.1016/j.bja.2018.02.007. Epub 2018 Mar 27.

  PMID: 29661384 BACKGROUND

• Ferreyra GP, Baussano I, Squadrone V, Richiardi L, Marchiaro G, Del Sorbo L, Mascia L, Merletti F, Ranieri VM. Continuous positive airway pressure for treatment of respiratory complications after abdominal surgery: a systematic review and meta-analysis. Ann Surg. 2008 Apr;247(4):617-26. doi: 10.1097/SLA.0b013e3181675829.

  PMID: 18362624 BACKGROUND

• Hulzebos E. Continuous positive airway pressure reduces respiratory complications following abdominal surgery. Aust J Physiother. 2008;54(3):217. doi: 10.1016/s0004-9514(08)70031-x. No abstract available.

  PMID: 18833685 BACKGROUND

Study Officials

• Thu Nguyen Dang

  Vietnam Military Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: the treatment allocation was unblinded to both the patient and the staffs
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 15, 2024
• Study Start: December 1, 2021
• Primary Completion: August 20, 2022
• Study Completion: August 30, 2022
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)