Lung InjuryNCT06375980
Intraoperative Mechanical Power and Ventilation-Associated Lung Injury: Assessing Complications
An observational study of Lung Injury and Pulmonary Complication, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Injury, Pulmonary Complication
- What is being tested?
- Intraoperative Mechanical Ventilation Strategies
- How many people
- 207 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 31 Dec 2022
- How long will I take part?
- 1 Day
- 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: The study population consisted of adult patients (aged 18 years and older) scheduled for elective major abdominal surgery.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Oncology Training and Research Hospital
Ankara, 06200
About this study
Official title: The Relationship Between Intraoperative Mechanical Power Applied to The Lung and Postoperative Pulmonary Complications in Patients Undergoing Major Abdominal Surgery
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."
Read the detailed description
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
- Lung Injury, Pulmonary Complication
- Being tested
- Intraoperative Mechanical Ventilation Strategies
- Keywords
- Lung injury, Ventilators, mechanical, Perioperative care, Anesthesia, Risk factors, Ventilator-Induced Lung Injury
- Medical subject headings
- Lung Injury, Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Mechanical Ventilation StrategiesOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Intraoperative Mechanical Ventilation Strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Patients were followed for 24 hours postoperatively to evaluate the occurrence of pulmonary complications.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start1 Apr 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lung InjuryStudies 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
- 207 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arif Timuroğlu, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Investigators
- Arif Timuroğlu, Study director, ankara oncology trainig and research hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375980
- Sponsor's protocol ID
- ANKARA_OR_MP
- Status last verified
- Jul 2024
- First submitted
- 17 Apr 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27222707Khan 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.
PubMed 16606377Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.
PubMed 28186222Jammer 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.
PubMed 25058504Senturk 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.
PubMed 37079284
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Intraoperative Mechanical Power Applied to The Lung and Postoperative Pulmonary Complications in Patients Undergoing Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06375980
- Acronym / sponsor ID
- ANKARA_OR_MP
- Conditions
- Lung Injury, Pulmonary Complication
- Keywords
- Lung injury, Ventilators, mechanical, Perioperative care, Anesthesia, Risk factors, Ventilator-Induced Lung Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 Apr 2024 (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.
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
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients who developed postoperative pulmonary complications | – | Other: Intraoperative Mechanical Ventilation StrategiesThis 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. |
| patients who did not develop postoperative pulmonary complications . | – | Other: Intraoperative Mechanical Ventilation StrategiesThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of adult patients (aged 18 years and older) scheduled for elective major abdominal surgery.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Intraoperative Mechanical Ventilation StrategiesThe 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 | Other | patients who developed postoperative pulmonary complications, patients who did not develop postoperative pulmonary complications . |
Primary outcome
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).
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 30 Jul 2024.
- Background: PubMed 27222707Patel 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.
- Background: PubMed 16606377Khan 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.
- Background: PubMed 28186222Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.
- Background: PubMed 25058504Jammer 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.
- Background: PubMed 37079284Senturk 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.
- Individual participant dataSharing planned: No
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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.
Arif Timuroğlu study director
ankara oncology trainig and research hospital
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 Lung Injury and Pulmonary Complication, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 7 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 30 Jul 2024. 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 Turkey (Türkiye). 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?
Relationship between mechanical power and postoperative pulmonary complications (time frame: Patients were followed for 24 hours postoperatively to evaluate the occurrence of pulmonary complications.). 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 NCT06375980, which also lists 5 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 30 Jul 2024.