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

NCT05814081 | Completed

• 1 other identifier: 21-20-07
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

mechanical power; prone; supine; postoperative pulmonary complications

Outcome Measures

Primary Outcomes (2)

• Mechanical power

  Mechanical power values calculated during surgery were compared.

  During surgery (2 hours to 4 hours)

• Postoperative complications

  Postoperative pulmonary complications were observed.

  Postoperative period (up to 10 days)

Secondary Outcomes (6)

• Respiratory parameters other than mechanical power

  During surgery (2 hours to 4 hours)

• Respiratory parameters other than mechanical power

  During surgery (2 hours to 4 hours)

• Respiratory parameters other than mechanical power

  During surgery (2 hours to 4 hours)

• Respiratory parameters other than mechanical power

  During surgery (2 hours to 4 hours)

• Respiratory parameters other than mechanical power

  During surgery (2 hours to 4 hours)

Study Arms (4)

Pressure Control Ventilation Supine Group

20 patients were ventilated in the supine position with pressure control mode.

Procedure: Position/Ventilation

Pressure Control Ventilation Prone Group

20 patients were ventilated in the prone position with pressure control mode.

Procedure: Position/Ventilation

Volume Control Ventilation Supine Group

20 patients were ventilated in the supine position with volume control mode.

Procedure: Position/Ventilation

Volume Control Ventilation Prone Group

20 patients were ventilated in the prone position with volume control mode.

Procedure: Position/Ventilation

Interventions

Position/Ventilation PROCEDURE

Positioning and ventilation mode adjustments were made to the patients.

Pressure Control Ventilation Prone Group; Pressure Control Ventilation Supine Group; Volume Control Ventilation Prone Group; Volume Control Ventilation Supine Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ASA I - III risk group patients
• Patients between the ages of 18-70
• At least 2 hours of mechanical ventilation time

You may not qualify if:

• 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

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Basaksehir Cam Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 24283226 RESULT

• 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.

  PMID: 26872367 RESULT

• 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.

  PMID: 27620287 RESULT

• 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.

  PMID: 28828361 RESULT

• 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.

  PMID: 31773328 RESULT

• 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.

  PMID: 31931417 RESULT

MeSH Terms

Conditions

Ventilator-Induced Lung Injury; Postoperative Complications; Deception

Interventions

Patient Positioning; Ventilation

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Environment, Controlled; Environment; Environment and Public Health

Study Officials

• Furkan Tontu

  Basaksehir Cam & Sakura City Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Anesthesiology and Reanimation Department, Principal Investigator

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 14, 2023
• Study Start: January 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: June 1, 2021
• Last Updated: April 14, 2023

Record last verified: 2023-04

Locations

TU (1)