Clinical trial NCT05814081: How To Prevent Ventilator-Related Lung Damage in Intraoperative Mechanical Ventilation? Pcv or Vcv ?
Official title: How To Prevent Ventilator-Related Lung Damage in Intraoperative Mechanical Ventilation? Pcv or Vcv ?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventilator-Induced Lung Injury
Ventilator Lung
Mechanical Ventilation Complication
Postoperative Complications
Keywords: mechanical power
prone
supine
postoperative pulmonary complications
Lead sponsor: Başakşehir Çam & Sakura City Hospital
Sponsor class: OTHER_GOV
First posted: 2023-04-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cervical hernia, lumbar hernia and lumbar stabilization cases who were operated in the neurosurgery operating room of the anesthesia and reanimation clinic were examined.

Brief summary: 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.

Detailed description: Although mechanical ventilation is a life-saving intervention, it can lead to ventilator-induced lung injury (VILI). VILI is the damage caused by positive pressure ventilation that starts with the use of mechanical ventilators. There are many factors that cause VILI such as tidal volume, drive pressure, flow, respiratory rate, and PEEP. Mechanical power, which collects these different variables in a single parameter, offers us new possibilities in predicting VILI at the bedside. The mechanical power being above a certain threshold causes damage ranging from pulmonary parenchymal rupture to severe inflammation and edema. Also, higher mechanical power values are associated with higher mortality. The protective ventilation strategy in intensive care units is also applied in operating rooms (OR) to minimize the risk of postoperative pulmonary complications due to VILI. While the volume control mode was at the forefront in the old anesthesia devices used in the OR, today there are anesthesia devices with many modes and features, as in intensive care units. This causes confusion in the use of mechanical ventilators in the perioperative period. Therefore, in this study, the investigators compared the perioperative mechanical power values in prone and supine positions, and postoperative pulmonary complications of two ventilation modes (volume control-pressure control ventilation). Thus, the investigators aimed to find out which ventilation mode would be advantageous in the perioperative period.

Eligibility criteria: 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

Primary outcomes:
measure: Mechanical power
timeFrame: During surgery (2 hours to 4 hours)
measure: Postoperative complications
timeFrame: Postoperative period (up to 10 days)
Secondary outcomes:
measure: Respiratory parameters other than mechanical power
timeFrame: During surgery (2 hours to 4 hours)
measure: Respiratory parameters other than mechanical power
timeFrame: During surgery (2 hours to 4 hours)
measure: Respiratory parameters other than mechanical power
timeFrame: During surgery (2 hours to 4 hours)
measure: Respiratory parameters other than mechanical power
timeFrame: During surgery (2 hours to 4 hours)
measure: Respiratory parameters other than mechanical power
timeFrame: During surgery (2 hours to 4 hours)
measure: Respiratory parameters other than mechanical power
timeFrame: During surgery (2 hours to 4 hours)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Basaksehir Cam Sakura City Hospital
Study officials:
affiliation: Basaksehir Cam & Sakura City Hospital
name: Furkan Tontu
role: STUDY_DIRECTOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.