How To Prevent Ventilator-Related Lung Damage in Intraoperative Mechanical Ventilation? Pcv or Vcv ?

Postoperative Complications Clinical Trial

Official title:

How To Prevent Ventilator-Related Lung Damage in Intraoperative Mechanical Ventilation? Pcv or Vcv ?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05814081
• Other study ID #: 21-20-07
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: June 1, 2021

Study information

• Verified date: April 2023
• Source: Basaksehir Cam & Sakura Sehir Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Injury
• Mechanical Ventilation Complication
• Postoperative Complications
• Ventilator Lung
• Ventilator-Induced Lung Injury

Intervention

Procedure:
• Position/Ventilation
Positioning and ventilation mode adjustments were made to the patients.

Locations

Country	Name	City	State
Turkey	Basaksehir Cam Sakura City Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Basaksehir Cam & Sakura Sehir Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View 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 — View 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: — View 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. do — View Citation

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. — View 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.2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mechanical power	Mechanical power values calculated during surgery were compared.	During surgery (2 hours to 4 hours)
Primary	Postoperative complications	Postoperative pulmonary complications were observed.	Postoperative period (up to 10 days)
Secondary	Respiratory parameters other than mechanical power	PEEP(mmHg) value measured during surgery were compared.	During surgery (2 hours to 4 hours)
Secondary	Respiratory parameters other than mechanical power	Tidal volume(ml) value measured during surgery were compared.	During surgery (2 hours to 4 hours)
Secondary	Respiratory parameters other than mechanical power	Peak pressure(mmHg) value measured during surgery were compared.	During surgery (2 hours to 4 hours)
Secondary	Respiratory parameters other than mechanical power	Plato pressure(mmHg) value measured during surgery were compared.	During surgery (2 hours to 4 hours)
Secondary	Respiratory parameters other than mechanical power	Driving pressure(mmHg) value measured during surgery were compared.	During surgery (2 hours to 4 hours)
Secondary	Respiratory parameters other than mechanical power	Inspiratory time(second) value measured during surgery were compared.	During surgery (2 hours to 4 hours)