Postoperative Pulmonary Complications (PPC)NCT07788313
Mechanical Power-Integrated Oxygenation Indices for Predicting Postoperative Pulmonary Complications After Major Abdominal Surgery
An observational study of Postoperative Pulmonary Complications (PPC), run by Hadeer Yasser Abd El-aliem at 1 site in Egypt.
Trial summary
The goal of this prospective observational study is to determine whether novel oxygenation and oxygen saturation indices that incorporate total or dynamic mechanical power can predict postoperative pulmonary complications (PPCs) in adults undergoing major abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pulmonary Complications (PPC)
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2025to 12 Jul 2026
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective open major abdominal surgeries (abdominal exploration, hepatectomy, gastrectomy) under general anaesthesia and mechanical ventilation at least 2 hours
Who may be able to join
- Age 18-60 years old.
- Both sexes.
- Patients undergoing elective open major abdominal surgeries (abdominal exploration, hepatectomy, gastrectomy) under general anaesthesia and mechanical ventilation at least 2 hours.
- ASA- physical status I/II
- without any known history of respiratory disease
Who cannot join
- Obstructive sleep apnea.
- Patients with chronic pulmonary diseases like COPD, asthma, or pulmonary fibrosis.
- Patients who have undergone major lung surgery.
- Patients dependent on mechanical ventilation or CPAP prior to surgery.
- Neurological disorders affecting respiratory function: Conditions like myasthenia gravis or Guillain-Barré syndrome.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrating the Ventilator Mechanical Power Into the Oxygenation and Saturation Indices for Prediction of Postoperative Pulmonary Complications After Major Abdominal Surgeries; a Prospective Observational Study
The goal of this prospective observational study is to determine whether novel oxygenation and oxygen saturation indices that incorporate total or dynamic mechanical power can predict postoperative pulmonary complications (PPCs) in adults undergoing major abdominal surgery. The main questions it aims to answer are:
- How well do OI-MPtot, OI-MPdyn, OSI-MPtot, and OSI-MPdyn predict PPCs within the first 7 days after surgery?
- Do these novel indices predict PPCs better than mechanical power (MPtot and MPdyn), conventional oxygenation and saturation indices (OI and OSI), and the preoperative ARISCAT score?
- What cutoff values and diagnostic accuracy of the novel indices can be used to identify patients at increased risk of PPCs?
Read more
Participants will:
- Undergo elective open major abdominal surgery under general anesthesia and mechanical ventilation.
- Have intraoperative mechanical ventilation parameters recorded hourly during surgery.
- Have mechanical power, oxygenation, and oxygen saturation indices calculated from the collected data.
- Be followed during their hospital stay and for 7 days after discharge for the occurrence of PPCs, including respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonitis.
- Have their clinical, surgical, and ventilatory characteristics recorded and compared according to whether PPCs occur.
- Being tested
- No Interventions
- Keywords
- ventilator mechanical power, composite indices, oxygenation and saturation indices, Postoperative pulmonary complications (PPC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
The study does not include interventions.
| Study group | Role | What they receive |
|---|---|---|
| Elective open major abdominal surgeries group | Patients undergoing elective open major abdominal surgeries (abdominal exploration, hepatectomy, gastrectomy) under general anaesthesia and mechanical ventilation at least 2 hours. Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative pulmonary complications (PPC)
Evaluate and compare the predictive capabilities of newly developed oxygenation and saturation indices, which incorporate MPtot and MPdyn instead of Pmean (OSI-MPtot, OI-MPtot, OSI-MPdyn, OI-MPdyn), for the occurrence of postoperative pulmonary complications (PPCs) within the first seven days following major abdominal surgeries.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Jul 2025
- Primary completion6 Jun 2026
- Study completion12 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pulmonary Complications (PPC)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadeer Yasser Abd El-aliem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hadeer Yasser Abd El-aliem, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788313
- Sponsor's protocol ID
- 472024
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Asar S, Rahim F, Rahimi P, Acicbe O, Tontu F, Cukurova Z. Novel Oxygenation and Saturation Indices for Mortality Prediction in COVID-19 ARDS Patients: The Impact of Driving Pressure and Mechanical Power. J Intensive Care Med. 2024 Jun;39(6):595-608. doi: 10.1177/08850666231223498. Epub 2024 Jan 5.
PubMed 38179691Scala R, Renda T, Bambina S, Guidelli L, Arniani S, Carrassa L, Oczkowski S. Oxygenation indices and early prediction of outcome in hypoxemic patients with COVID-19 pneumonia requiring noninvasive respiratory support in pulmonary intermediate care unit. Pneumonia (Nathan). 2024 Nov 25;16(1):22. doi: 10.1186/s41479-024-00145-9.
PubMed 39582005
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating the Ventilator Mechanical Power Into the Oxygenation and Saturation Indices for Prediction of Postoperative Pulmonary Complications After Major Abdominal Surgeries; a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07788313
- Acronym / sponsor ID
- 472024
- Keywords
- ventilator mechanical power, composite indices, oxygenation and saturation indices, Postoperative pulmonary complications (PPC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hadeer Yasser Abd El-aliemUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 6 Jun 2026 (actual)
- Study completion
- 12 Jul 2026 (actual)
- First posted
- 26 Aug 2026 (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.
The goal of this prospective observational study is to determine whether novel oxygenation and oxygen saturation indices that incorporate total or dynamic mechanical power can predict postoperative pulmonary complications (PPCs) in adults undergoing major abdominal surgery. The main questions it aims to answer are:
- How well do OI-MPtot, OI-MPdyn, OSI-MPtot, and OSI-MPdyn predict PPCs within the first 7 days after surgery?
- Do these novel indices predict PPCs better than mechanical power (MPtot and MPdyn), conventional oxygenation and saturation indices (OI and OSI), and the preoperative ARISCAT score?
- What cutoff values and diagnostic accuracy of the novel indices can be used to identify patients at increased risk of PPCs?
Participants will:
- Undergo elective open major abdominal surgery under general anesthesia and mechanical ventilation.
- Have intraoperative mechanical ventilation parameters recorded hourly during surgery.
- Have mechanical power, oxygenation, and oxygen saturation indices calculated from the collected data.
- Be followed during their hospital stay and for 7 days after discharge for the occurrence of PPCs, including respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonitis.
- Have their clinical, surgical, and ventilatory characteristics recorded and compared according to whether PPCs occur.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective open major abdominal surgeries group | – | Other: No InterventionsPatients undergoing elective open major abdominal surgeries (abdominal exploration, hepatectomy, gastrectomy) under general anaesthesia and mechanical ventilation at least 2 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective open major abdominal surgeries (abdominal exploration, hepatectomy, gastrectomy) under general anaesthesia and mechanical ventilation at least 2 hours
Key inclusion criteria (5 listed)
- Age 18-60 years old.
- Both sexes.
- Patients undergoing elective open major abdominal surgeries (abdominal exploration, hepatectomy, gastrectomy) under general anaesthesia and mechanical ventilation at least 2 hours.
- ASA- physical status I/II
- without any known history of respiratory disease
Key exclusion criteria (6 listed)
- Obstructive sleep apnea.
- Patients with chronic pulmonary diseases like COPD, asthma, or pulmonary fibrosis.
- Patients who have undergone major lung surgery.
- Patients dependent on mechanical ventilation or CPAP prior to surgery.
- Neurological disorders affecting respiratory function: Conditions like myasthenia gravis or Guillain-Barré syndrome.
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 |
|---|---|---|
| No InterventionsThe study does not include interventions. | Other | Elective open major abdominal surgeries group |
Primary outcome
Incidence of Postoperative pulmonary complications (PPC)
Time frame: one year
Evaluate and compare the predictive capabilities of newly developed oxygenation and saturation indices, which incorporate MPtot and MPdyn instead of Pmean (OSI-MPtot, OI-MPtot, OSI-MPdyn, OI-MPdyn), for the occurrence of postoperative pulmonary complications (PPCs) within the first seven days following major abdominal surgeries.
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 26 Aug 2026.
- Background: PubMed 38179691Asar S, Rahim F, Rahimi P, Acicbe O, Tontu F, Cukurova Z. Novel Oxygenation and Saturation Indices for Mortality Prediction in COVID-19 ARDS Patients: The Impact of Driving Pressure and Mechanical Power. J Intensive Care Med. 2024 Jun;39(6):595-608. doi: 10.1177/08850666231223498. Epub 2024 Jan 5.
- Background: PubMed 39582005Scala R, Renda T, Bambina S, Guidelli L, Arniani S, Carrassa L, Oczkowski S. Oxygenation indices and early prediction of outcome in hypoxemic patients with COVID-19 pneumonia requiring noninvasive respiratory support in pulmonary intermediate care unit. Pneumonia (Nathan). 2024 Nov 25;16(1):22. doi: 10.1186/s41479-024-00145-9.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pulmonary Complications (PPC), run by Hadeer Yasser Abd El-aliem at 1 site in Egypt.
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 5 inclusion and 6 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 26 Aug 2026. 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 Egypt. 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?
Incidence of Postoperative pulmonary complications (PPC) (time frame: one year). 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 NCT07788313, which also lists 2 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 26 Aug 2026.