Clinical trial NCT06260826: CPAP on Oxygenation and Pulmonary Function in Elderly Patients After Major Open Abdominal Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Continuous Positive Airway Pressure
Pulmonary Function
Older People
Keywords: Continuous Positive Airway Pressure
Pulmonary Function
Elderly patients
Abdominal open surgery
Lead sponsor: Vietnam Military Medical University
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were randomly assigned in a 1:1 ratio to either the O2-Max Trio or JPAP group through a computer-generated randomization list .
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: The oxygenation-PaO2/FiO2
timeFrame: Three time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAP
Secondary outcomes:
measure: The forced vital capacity (FVC)
timeFrame: Three time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAP
measure: The forced expiratory volume in the first second-FEV1
timeFrame: Three time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAP
measure: The FEV1/FVC ratio
timeFrame: Three time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAP
measure: The peak expiratory flow-PEF
timeFrame: Three time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAP
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: VietXo Friendship Hospital
Study officials:
affiliation: Vietnam Military Medical University
name: Thu Nguyen Dang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.