Intraoperative Mechanical Power and Ventilation-Associated Lung Injury: Assessing Complications

NCT ID: NCT06375980

Last Updated: 2024-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

207 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study investigates the relationship between intraoperative mechanical power and postoperative pulmonary complications in patients undergoing major abdominal surgery. The investigators record mechanical ventilation parameters and surgical characteristics, assessing the incidence of pulmonary complications within 24 hours postoperatively."

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Postoperative pulmonary complications (PPCs) are often underestimated yet remain a leading cause of perioperative morbidity and mortality. These complications encompass postoperative hypoxia, atelectasis, bronchospasm, pulmonary infections, infiltrations, aspiration pneumonia, acute respiratory distress syndrome (ARDS), pleural effusion, and pulmonary edema. They are prevalent and associated with significant costs, prolonging hospital stays, ventilation duration, and ICU admissions, while also increasing mortality and morbidity risks.

Perioperative mechanical ventilation stands as a primary risk factor for the development of postoperative pulmonary complications. Approximately one in four patients with normal lungs will develop some form of lung injury following mechanical ventilation, although much of this damage can be mitigated through the use of appropriate ventilation strategies. A range of pulmonary complications induced by mechanical ventilation is known as ventilator-induced lung injury (VILI).

A growing understanding of the injury mechanism aids researchers in identifying risk factors for lung injury, including tidal volume, respiratory rate, pressures, and flow. Mechanical power, which combines tidal volume, respiratory rate, and airway pressure, has been identified as a potential contributor to VILI. The greater the power, the higher the likelihood of lung injury occurring.

Mechanical power represents the total energy expended over a specific period and is typically expressed in joules per minute (J/min). The equation for mechanical power can help estimate the contribution of different causes of VILI and their variations. This equation can be easily applied in the software of each ventilator. Recent studies have investigated threshold values for mechanical power in relation to ventilator-associated lung injury using the simplified formula found for mechanical power

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Injury Pulmonary Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

patients who developed postoperative pulmonary complications

This cohort consists of patients who developed postoperative pulmonary complications (PPCs). The cohort of patients developing PPCs includes individuals who experienced postoperative hypoxia, atelectasis, bronchospasm, pulmonary infection, pulmonary infiltration, aspiration pneumonia, acute respiratory distress syndrome, pleural effusion, and pulmonary edema. PPCs were assessed using the European Perioperative Clinical Outcome framework.

Intraoperative Mechanical Ventilation Strategies

Intervention Type OTHER

The intervention involves the management of mechanical ventilation during major abdominal surgery. This includes the adjustment of ventilation parameters such as tidal volume, respiratory rate, peak pressure, positive end-expiratory pressure (PEEP), and inspiratory flow rate. The aim is to optimize ventilation strategies to reduce the risk of postoperative pulmonary complications

patients who did not develop postoperative pulmonary complications .

This cohort comprises patients who did not develop postoperative pulmonary complications (PPCs). The cohort of patients not developing PPCs includes individuals who did not exhibit significant pulmonary complications postoperatively.

Intraoperative Mechanical Ventilation Strategies

Intervention Type OTHER

The intervention involves the management of mechanical ventilation during major abdominal surgery. This includes the adjustment of ventilation parameters such as tidal volume, respiratory rate, peak pressure, positive end-expiratory pressure (PEEP), and inspiratory flow rate. The aim is to optimize ventilation strategies to reduce the risk of postoperative pulmonary complications

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intraoperative Mechanical Ventilation Strategies

The intervention involves the management of mechanical ventilation during major abdominal surgery. This includes the adjustment of ventilation parameters such as tidal volume, respiratory rate, peak pressure, positive end-expiratory pressure (PEEP), and inspiratory flow rate. The aim is to optimize ventilation strategies to reduce the risk of postoperative pulmonary complications

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients aged 18 years and older
* Patients undergoing elective major abdominal surgery
* Patients with ASA (American Society of Anesthesiologists) physical status classification I-IV
* Patients capable of providing voluntary consent

Exclusion Criteria

* Patients under 18 years of age
* Pregnant individuals
* Those who decline to participate in the study
* Patients requiring reoperation due to surgical complications
* Organ transplant recipients
* Patients who were intubated preoperatively
* Day surgery patients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Arif Timuroğlu

Lead Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Arif Timuroğlu

Role: STUDY_DIRECTOR

ankara oncology trainig and research hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ankara Oncology Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Patel K, Hadian F, Ali A, Broadley G, Evans K, Horder C, Johnstone M, Langlands F, Matthews J, Narayan P, Rallon P, Roberts C, Shah S, Vohra R. Postoperative pulmonary complications following major elective abdominal surgery: a cohort study. Perioper Med (Lond). 2016 May 23;5:10. doi: 10.1186/s13741-016-0037-0. eCollection 2016.

Reference Type BACKGROUND
PMID: 27222707 (View on PubMed)

Khan NA, Quan H, Bugar JM, Lemaire JB, Brant R, Ghali WA. Association of postoperative complications with hospital costs and length of stay in a tertiary care center. J Gen Intern Med. 2006 Feb;21(2):177-80. doi: 10.1111/j.1525-1497.2006.00319.x.

Reference Type BACKGROUND
PMID: 16606377 (View on PubMed)

Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.

Reference Type BACKGROUND
PMID: 28186222 (View on PubMed)

Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.

Reference Type BACKGROUND
PMID: 25058504 (View on PubMed)

Senturk E, Ugur S, Celik Y, Cukurova Z, Asar S, Cakar N. The power of mechanical ventilation may predict mortality in critically ill patients. Minerva Anestesiol. 2023 Jul-Aug;89(7-8):663-670. doi: 10.23736/S0375-9393.23.17080-5. Epub 2023 Apr 20.

Reference Type BACKGROUND
PMID: 37079284 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ANKARA_OR_MP

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.