Mechanical Power-Integrated Oxygenation Indices for Predicting Postoperative Pulmonary Complications After Major Abdominal Surgery

NCT07788313 | Completed DMC

• 1 other identifier: 472024
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Postoperative Pulmonary Complications (PPC)

Keywords

ventilator mechanical power; composite indices; oxygenation and saturation indices; Postoperative pulmonary complications (PPC)

Outcome Measures

Primary Outcomes (1)

• 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.

  one year

Study Arms (1)

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.

Other: No Interventions

Interventions

No Interventions OTHER

The study does not include interventions.

Elective open major abdominal surgeries group

Eligibility Criteria

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

Study Population

Patients undergoing elective open major abdominal surgeries (abdominal exploration, hepatectomy, gastrectomy) under general anaesthesia and mechanical ventilation at least 2 hours

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hadeer Yasser Abd El-aliem: lead

Study Sites (1)

Benha University, Faculty of Medicine

Banhā, 13511, Egypt

Location

Related Publications (2)

• 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.

  PMID: 38179691 BACKGROUND

• Scala 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.

  PMID: 39582005 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology and Intensive Care

Study Record Dates

• First Submitted: August 23, 2026
• First Posted: August 26, 2026
• Study Start: July 1, 2025
• Primary Completion: June 6, 2026
• Study Completion: July 12, 2026
• Last Updated: August 26, 2026

Record last verified: 2026-08

Locations

EG (1)