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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06260826
Acronym
CPAP
Enrollment
60
Registered
2024-02-15
Start date
2021-12-01
Completion date
2022-08-30
Last updated
2024-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Continuous Positive Airway Pressure, Older People, Pulmonary Function

Keywords

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

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).

Interventions

DEVICEAuto 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

DEVICEConstant 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

Sponsors

Nguyen Dang Thu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

the treatment allocation was unblinded to both the patient and the staffs

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 .

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The oxygenation-PaO2/FiO2Three time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAPThe 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.

Secondary

MeasureTime frameDescription
The forced vital capacity (FVC)Three time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAPForced vital capacity (FVC) was evaluated by spirometry test. The parameter was measured with Spirobank II Advanced (Medical International Research, Roma, Italia)
The forced expiratory volume in the first second-FEV1Three time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAPThe 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)
The FEV1/FVC ratioThree time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAPThe FEV1/FVC ratio was evaluated by spirometry test. The parameter was measured with Spirobank II Advanced (Medical International Research, Roma, Italia)
The peak expiratory flow-PEFThree time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAPThe peak expiratory flow-PEF was evaluated by spirometry test. The parameter was measured with Spirobank II Advanced (Medical International Research, Roma, Italia)

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026