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

Sponsor
Basaksehir Cam & Sakura Şehir Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05814081
Collaborator
(none)
80
1
5
16.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Position/Ventilation

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.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
80 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
How To Prevent Ventilator-Related Lung Damage in Intraoperative Mechanical Ventilation? Pcv or Vcv ?
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
May 1, 2021
Actual Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Pressure Control Ventilation Supine Group

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

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

Pressure Control Ventilation Prone Group

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

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

Volume Control Ventilation Supine Group

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

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

Volume Control Ventilation Prone Group

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

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

Outcome Measures

Primary Outcome Measures

  1. Mechanical power [During surgery (2 hours to 4 hours)]

    Mechanical power values calculated during surgery were compared.

  2. Postoperative complications [Postoperative period (up to 10 days)]

    Postoperative pulmonary complications were observed.

Secondary Outcome Measures

  1. Respiratory parameters other than mechanical power [During surgery (2 hours to 4 hours)]

    PEEP(mmHg) value measured during surgery were compared.

  2. Respiratory parameters other than mechanical power [During surgery (2 hours to 4 hours)]

    Tidal volume(ml) value measured during surgery were compared.

  3. Respiratory parameters other than mechanical power [During surgery (2 hours to 4 hours)]

    Peak pressure(mmHg) value measured during surgery were compared.

  4. Respiratory parameters other than mechanical power [During surgery (2 hours to 4 hours)]

    Plato pressure(mmHg) value measured during surgery were compared.

  5. Respiratory parameters other than mechanical power [During surgery (2 hours to 4 hours)]

    Driving pressure(mmHg) value measured during surgery were compared.

  6. Respiratory parameters other than mechanical power [During surgery (2 hours to 4 hours)]

    Inspiratory time(second) value measured during surgery were compared.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Basaksehir Cam Sakura City Hospital Istanbul Turkey

Sponsors and Collaborators

  • Basaksehir Cam & Sakura Şehir Hospital

Investigators

  • Study Director: Furkan Tontu, Basaksehir Cam Sakura City Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Furkan Tontu, Anesthesiologist, Anesthesiology and Reanimation Department, Principal Investigator, Basaksehir Cam & Sakura Şehir Hospital
ClinicalTrials.gov Identifier:
NCT05814081
Other Study ID Numbers:
  • 21-20-07
First Posted:
Apr 14, 2023
Last Update Posted:
Apr 14, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Furkan Tontu, Anesthesiologist, Anesthesiology and Reanimation Department, Principal Investigator, Basaksehir Cam & Sakura Şehir Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 14, 2023