NCT06375980

Brief Summary

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."

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2024

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

9 months

First QC Date

April 17, 2024

Last Update Submit

July 29, 2024

Conditions

Keywords

Lung injuryVentilators, mechanicalPerioperative careAnesthesiaRisk factorsVentilator-Induced Lung Injury

Outcome Measures

Primary Outcomes (1)

  • Relationship between mechanical power and postoperative 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).

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

Study Arms (2)

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.

Other: Intraoperative Mechanical Ventilation Strategies

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.

Other: Intraoperative Mechanical Ventilation Strategies

Interventions

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 developed postoperative pulmonary complicationspatients who did not develop postoperative pulmonary complications .

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consisted of adult patients (aged 18 years and older) scheduled for elective major abdominal surgery.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Oncology Training and Research Hospital

Ankara, 06200, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 27222707BACKGROUND
  • 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.

    PMID: 16606377BACKGROUND
  • Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.

    PMID: 28186222BACKGROUND
  • 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.

    PMID: 25058504BACKGROUND
  • 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.

    PMID: 37079284BACKGROUND

MeSH Terms

Conditions

Lung InjuryVentilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesThoracic InjuriesWounds and Injuries

Study Officials

  • Arif Timuroğlu

    ankara oncology trainig and research hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lead Researcher

Study Record Dates

First Submitted

April 17, 2024

First Posted

April 19, 2024

Study Start

April 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations