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NCT Number: NCT06375980

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

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."

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Oncology Training and Research Hospital

Ankara, 06200, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraoperative Mechanical Ventilation Strategies

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

Primary outcomes

  1. Relationship between mechanical power and postoperative pulmonary complications

    Time frame: Patients were followed for 24 hours postoperatively to evaluate the occurrence of pulmonary complications.

    This study aimed to assess the association between mechanical power and postoperative pulmonary complications. Mechanical power is a crucial parameter for predicting the risk of lung injury related to mechanical ventilation.

    Measurement Tool: Mechanical power calculation based on ventilator parameters. Unit of Measure: Mechanical power expressed in joules per minute (J/min).

Sponsors and collaborators

Lead sponsor

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Other

Registry information

Official study title

The Relationship Between Intraoperative Mechanical Power Applied to The Lung and Postoperative Pulmonary Complications in Patients Undergoing Major Abdominal Surgery

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 19, 2024
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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