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

April 3, 2023 updated by: Furkan Tontu, Basaksehir Cam & Sakura Şehir Hospital

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

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 Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey
        • Basaksehir Cam Sakura City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
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.
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.
Positioning and ventilation mode adjustments were made to the patients.

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)
Mechanical power values calculated during surgery were compared.
During surgery (2 hours to 4 hours)
Postoperative complications
Time Frame: Postoperative period (up to 10 days)
Postoperative pulmonary complications were observed.
Postoperative period (up to 10 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory parameters other than mechanical power
Time Frame: During surgery (2 hours to 4 hours)
PEEP(mmHg) value measured during surgery were compared.
During surgery (2 hours to 4 hours)
Respiratory parameters other than mechanical power
Time Frame: During surgery (2 hours to 4 hours)
Tidal volume(ml) value measured during surgery were compared.
During surgery (2 hours to 4 hours)
Respiratory parameters other than mechanical power
Time Frame: During surgery (2 hours to 4 hours)
Peak pressure(mmHg) value measured during surgery were compared.
During surgery (2 hours to 4 hours)
Respiratory parameters other than mechanical power
Time Frame: During surgery (2 hours to 4 hours)
Plato pressure(mmHg) value measured during surgery were compared.
During surgery (2 hours to 4 hours)
Respiratory parameters other than mechanical power
Time Frame: During surgery (2 hours to 4 hours)
Driving pressure(mmHg) value measured during surgery were compared.
During surgery (2 hours to 4 hours)
Respiratory parameters other than mechanical power
Time Frame: During surgery (2 hours to 4 hours)
Inspiratory time(second) value measured during surgery were compared.
During surgery (2 hours to 4 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

May 1, 2021

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

March 16, 2023

First Submitted That Met QC Criteria

April 3, 2023

First Posted (Actual)

April 14, 2023

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 3, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Not decided yet.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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