- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05814081
How To Prevent Ventilator-Related Lung Damage in Intraoperative Mechanical Ventilation? Pcv or Vcv ?
Introduction: Intraoperative Mechanical Ventilation practices can lead to ventilator-associated lung injury (VILI) and postoperative pulmonary complications in healthy lungs. Mechanical Power has been developed as a new concept in reducing the risk of postoperative pulmonary complications as it takes into account all respiratory mechanics that cause VILI formation. Volume control mode is at the forefront in the old anesthesia devices used in the operating room, and today, together with technology, there are anesthesia devices with many modes and features, as in intensive care units. This causes confusion in the use of mechanical ventilators. In this study, volume and pressure control ventilation modes were compared in terms of respiratory mechanics (including mechanical power) in patients operated in the supine and prone positions.
Aim of study: It has been compared the effects on postoperative pulmonary complications (PPH) in terms of VILI risk by calculating mechanical power from advanced respiratory mechanics of patients ventilated in pressure and volume control modes, which are frequently used in operating room applications.
Conclusion: There was no statistically significant difference between the groups in terms of demographic data, ariscat score, and ariscat risk group values. The supine and prone mechanical power (MPrs) values of the volume control group were statistically significantly lower than the pressure control group. P values were calculated as 0.012 and 0.001, respectively.
Results: Supine and prone MPrs values of the volume control group were calculated significantly lower than the pressure control group. Pressure-controlled intraoperative mechanical ventilation is considered to be disadvantageous in terms of the risk of VILI in the supine and prone position in terms of the current mechanical power concept.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey
- Basaksehir Cam Sakura City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- ASA I - III risk group patients
- Patients between the ages of 18-70
- At least 2 hours of mechanical ventilation time
Exclusion Criteria:
- Patients with COPD or Asthma bronchial
- Patients with a functional capacity of less than 7 METS
- Pregnant and lactating female patients.
- Patients who have had thoracic surgery before
- Patients with BMI above 35
- Patients who had hemodynamic instability or desaturation (SpO2<92%) during the operation
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pressure Control Ventilation Supine Group
20 patients were ventilated in the supine position with pressure control mode.
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Positioning and ventilation mode adjustments were made to the patients.
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Pressure Control Ventilation Prone Group
20 patients were ventilated in the prone position with pressure control mode.
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Positioning and ventilation mode adjustments were made to the patients.
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Volume Control Ventilation Supine Group
20 patients were ventilated in the supine position with volume control mode.
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Positioning and ventilation mode adjustments were made to the patients.
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Volume Control Ventilation Prone Group
20 patients were ventilated in the prone position with volume control mode.
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Positioning and ventilation mode adjustments were made to the patients.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mechanical power
Time Frame: During surgery (2 hours to 4 hours)
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Mechanical power values calculated during surgery were compared.
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During surgery (2 hours to 4 hours)
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Postoperative complications
Time Frame: Postoperative period (up to 10 days)
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Postoperative pulmonary complications were observed.
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Postoperative period (up to 10 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Respiratory parameters other than mechanical power
Time Frame: During surgery (2 hours to 4 hours)
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PEEP(mmHg) value measured during surgery were compared.
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During surgery (2 hours to 4 hours)
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Respiratory parameters other than mechanical power
Time Frame: During surgery (2 hours to 4 hours)
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Tidal volume(ml) value measured during surgery were compared.
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During surgery (2 hours to 4 hours)
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Respiratory parameters other than mechanical power
Time Frame: During surgery (2 hours to 4 hours)
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Peak pressure(mmHg) value measured during surgery were compared.
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During surgery (2 hours to 4 hours)
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Respiratory parameters other than mechanical power
Time Frame: During surgery (2 hours to 4 hours)
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Plato pressure(mmHg) value measured during surgery were compared.
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During surgery (2 hours to 4 hours)
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Respiratory parameters other than mechanical power
Time Frame: During surgery (2 hours to 4 hours)
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Driving pressure(mmHg) value measured during surgery were compared.
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During surgery (2 hours to 4 hours)
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Respiratory parameters other than mechanical power
Time Frame: During surgery (2 hours to 4 hours)
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Inspiratory time(second) value measured during surgery were compared.
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During surgery (2 hours to 4 hours)
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Collaborators and Investigators
Investigators
- Study Director: Furkan Tontu, Basaksehir Cam Sakura City Hospital
Publications and helpful links
General Publications
- Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. No abstract available. Erratum In: N Engl J Med. 2014 Apr 24;370(17):1668-9.
- Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.
- Cressoni M, Gotti M, Chiurazzi C, Massari D, Algieri I, Amini M, Cammaroto A, Brioni M, Montaruli C, Nikolla K, Guanziroli M, Dondossola D, Gatti S, Valerio V, Vergani GL, Pugni P, Cadringher P, Gagliano N, Gattinoni L. Mechanical Power and Development of Ventilator-induced Lung Injury. Anesthesiology. 2016 May;124(5):1100-8. doi: 10.1097/ALN.0000000000001056.
- Tonetti T, Vasques F, Rapetti F, Maiolo G, Collino F, Romitti F, Camporota L, Cressoni M, Cadringher P, Quintel M, Gattinoni L. Driving pressure and mechanical power: new targets for VILI prevention. Ann Transl Med. 2017 Jul;5(14):286. doi: 10.21037/atm.2017.07.08.
- Giosa L, Busana M, Pasticci I, Bonifazi M, Macri MM, Romitti F, Vassalli F, Chiumello D, Quintel M, Marini JJ, Gattinoni L. Mechanical power at a glance: a simple surrogate for volume-controlled ventilation. Intensive Care Med Exp. 2019 Nov 27;7(1):61. doi: 10.1186/s40635-019-0276-8.
- Asar S, Acicbe O, Cukurova Z, Hergunsel GO, Canan E, Cakar N. Bedside dynamic calculation of mechanical power: A validation study. J Crit Care. 2020 Apr;56:167-170. doi: 10.1016/j.jcrc.2019.12.027. Epub 2020 Jan 2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-20-07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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