Continuous Positive Airway PressureCPAPNCT06260826
CPAP on Oxygenation and Pulmonary Function in Elderly Patients After Major Open Abdominal Surgery
A study testing Auto CPAP via nasal mask (JPAP machine) and Constant CPAP via facial mask (O2-Max Trio system) in people with Continuous Positive Airway Pressure and Pulmonary Function, run by Nguyen Dang Thu at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Continuous Positive Airway Pressure, Pulmonary Function, Older People
- What is being tested?
- Auto CPAP via nasal mask (JPAP machine) and Constant CPAP via facial mask (O2-Max Trio system)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Dec 2021to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Upper airway deformities
- Significant bullous emphysema
- Bronchopleural fistula
- Facial deformation
- Non-epidural anesthesia
- Hemodynamic unstable
- Inability to provide consent.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Being tested
- Auto CPAP via nasal mask (JPAP machine), Constant CPAP via facial mask (O2-Max Trio system)
- Keywords
- Continuous Positive Airway Pressure, Pulmonary Function, Elderly patients, Abdominal open surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: Constant CPAP via facial mask (O2-Max Trio system) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Forced vital capacity (FVC) was evaluated by spirometry test. The parameter was measured with Spirobank II Advanced (Medical International Research, Roma, Italia)
Measured: 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
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)
Measured: Three time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAP
The FEV1/FVC ratio
The FEV1/FVC ratio was evaluated by spirometry test. The parameter was measured with Spirobank II Advanced (Medical International Research, Roma, Italia)
Measured: Three time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAP
The peak expiratory flow-PEF
The peak expiratory flow-PEF was evaluated by spirometry test. The parameter was measured with Spirobank II Advanced (Medical International Research, Roma, Italia)
Measured: Three time points: Before surgery, arrival at the post-anesthesia care unit (before CPAP), and 1 hour after CPAP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start1 Dec 2021
- Primary completion20 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Continuous Positive Airway PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 .
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nguyen Dang Thu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nguyen Dang Thu, Vietnam Military Medical University
- Investigators
- Thu Nguyen Dang, Principal investigator, Vietnam Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260826
- Sponsor's protocol ID
- 3977/QĐ-HVQY
- Acronym
- CPAP
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35429325Garutti 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.
PubMed 24496783Ireland 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.
PubMed 25081420Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.
PubMed 28186222Abbott 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.
PubMed 29661384Ferreyra 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.
PubMed 18362624Hulzebos 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.
PubMed 18833685Thu ND, Thuy NT, Nguyen LS, Thang CQ, Thach NN, Kien NT. Comparison of automatic versus constant CPAP in elderly patients after major abdominal surgery: a randomized noninferiority trial. Braz J Anesthesiol. 2025 Sep-Oct;75(5):844642. doi: 10.1016/j.bjane.2025.844642. Epub 2025 May 17.
PubMed 40389032
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06260826
- Acronym / sponsor ID
- CPAP / 3977/QĐ-HVQY
- Keywords
- Continuous Positive Airway Pressure, Pulmonary Function, Elderly patients, Abdominal open surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nguyen Dang ThuUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 20 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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 .
| Arm | Type | Receives |
|---|---|---|
| Auto-CPAP via nasal mask | Experimental | Device: Auto CPAP via nasal mask (JPAP machine)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. |
| Constant-CPAP via facial mask | Active comparator | 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 and maintained a CPAP at 7.5 cm H2O |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Upper airway deformities
- Significant bullous emphysema
- Bronchopleural fistula
- Facial deformation
- Non-epidural anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Auto-CPAP via nasal mask |
| 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 | Device | Constant-CPAP via facial mask |
Primary outcome
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.
4 secondary outcomes
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
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 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 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Background: PubMed 35429325Osterkamp 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.
- Background: PubMed 24496783Garutti 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.
- Background: PubMed 25081420Ireland 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.
- Background: PubMed 28186222Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.
- Background: PubMed 29661384Abbott 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.
- Background: PubMed 18362624Ferreyra 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.
- Background: PubMed 18833685Hulzebos 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.
- Derived from this study: PubMed 40389032Thu ND, Thuy NT, Nguyen LS, Thang CQ, Thach NN, Kien NT. Comparison of automatic versus constant CPAP in elderly patients after major abdominal surgery: a randomized noninferiority trial. Braz J Anesthesiol. 2025 Sep-Oct;75(5):844642. doi: 10.1016/j.bjane.2025.844642. Epub 2025 May 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thu Nguyen Dang principal investigator
Vietnam Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auto CPAP via nasal mask (JPAP machine) and Constant CPAP via facial mask (O2-Max Trio system) in people with Continuous Positive Airway Pressure and Pulmonary Function, run by Nguyen Dang Thu at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06260826, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.