Mechanical Power in Pediatric Mechanical Ventilation

July 8, 2022 updated by: Ahmet YUKSEK, Bozok University

Can Mechanical Power be Used as a Safety Precaution in Pediatric Patients?

Mechanical power is the amount of energy transferred to the respiratory system of patients during each breath period. After overcoming the resistances required for respiration, the remaining energy may end up by damaging the lung parenchyma. Promising studies are showing that this amount of energy, which can be calculated mathematically, can be used as a single indicator instead of the limits used for barotrauma, volu-trauma, or atelecto-trauma in adult patients. However, the MP limit that should not be exceeded in pediatric patients is not yet clear. In this study, we present our MP calculations in pediatric anesthesia

Study Overview

Detailed Description

Mechanical ventilation is applied to millions of healthy and sick lungs every year in perioperative conditions and intensive care units. Meanwhile, the energy applied to the lungs by the ventilator during mechanical ventilation is usually used to overcome resistance in the chest wall and airways. Leftover energy is consumed by temperature, inflammation, and potentially lung tissue damage (1). The risk of ventilation-related damage increases in lungs with impaired homogeneity and ventilation-perfusion imbalance (1). As demonstrated by experimental and clinical studies, mechanical ventilation-induced lung injury (VILI) is associated with tidal volume, peak pressure, respiratory rate, and airflow. The physical force applied during ventilation TV increases exponentially with driving pressures (ΔPaw), flow (exponent = 2), and respiration rate (RR) (exponent = 1.4), and linearly with positive end-expiratory pressure (PEEP) (2). When the effects of these parameters are formulated, the energy applied to the lungs is revealed. This energy has been formulated as Joule/minute and has now taken its place as mechanical power (MP) in the literature. (2). A benefit of the MP calculation is that it is a single, easily calculated indicator parameter that can be used for the risks of barotrauma, volutrauma, or atelectotrauma associated with VILI. As shown in different publications, high MP values were associated with negative outcomes such as increased 30-day mortality in intensive care patients, increased length of stay in hospital and intensive care unit, and decreased number of ventilator-free days(3)(4). Cressoni et al. showed in their experimental study that MP values above 12 J/min in healthy pigs are associated with MV-related complications and this value can also be used as an alarm limit in humans(5). In addition, Costa et al found that 0.32 ± 0.14 J / min/ kg indexed MP(MP/Kg) was associated with increased mortality in ARDS patients(6). Some recent studies also support the conclusion that Mp calculation is beneficial(7)(8). For this reason, Gattinoni et al. suggests that MP limits and formula should be added to the mechanical ventilator software(2). However, studies on MP have often focused on ARDS and have been performed on intensive care patients or experimental animal models(9). Although MP is a promising safety limit with its easy computability, there are still questions about the formula and its usefulness. The success of the MP formula in perioperative situations and especially in pediatric patients has not been adequately tested. As far as we know, our study is one of the first publications to question the MP threshold in healthy pediatric cases.

In this study, our primary aim is to calculate the MP applied in pediatric cases who will undergo inguinal hernia surgery under general anesthesia.

Our other aims are the calculation of the mechanical power applied per kilogram and the other transferred energies, their comparison with the literature, and questioning the possible contribution of a mechanical power formula to safe mechanical ventilation in pediatric cases.

Study Type

Observational

Enrollment (Actual)

34

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

      • Yozgat, Turkey, 66001
        • Bozok Univesity 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

1 second to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients under the age of 18 who will undergo laparoscopic lower abdomen surgery under general anesthesia under elective conditions.

Description

Inclusion Criteria:

- To undergo laparoscopic lower abdomen surgery under general anesthesia under elective conditions under the age of 18

Exclusion Criteria:

- Patients in both groups weill be excluded if they had uncorrected congenital heart disease, pre-existing lung or airway disease, conditions that may decrease chest wall compliance, chronic respiratory failure requiring long-term MV, and tracheostomy.

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
median mechanical power
Time Frame: Measurements will be taken after half an hour of mechanical ventilation.
mechanical force applied to the lungs during mechanical ventilation, calculated according to the formula
Measurements will be taken after half an hour of mechanical ventilation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
indexed mechanical power
Time Frame: Data will be obtained at the beginning of the operation and after half an hour of ventilation
mechanical power and other mechanical ventilator parameters applied according to the weight of the patients
Data will be obtained at the beginning of the operation and after half an hour of ventilation

Collaborators and Investigators

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

Investigators

  • Study Chair: Ahmet YUKSEK, asst.prof, Yozgat Bozok Universitesi

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.

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)

August 10, 2021

Primary Completion (Actual)

December 10, 2021

Study Completion (Actual)

January 10, 2022

Study Registration Dates

First Submitted

November 12, 2021

First Submitted That Met QC Criteria

November 18, 2021

First Posted (Actual)

November 19, 2021

Study Record Updates

Last Update Posted (Actual)

July 11, 2022

Last Update Submitted That Met QC Criteria

July 8, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2017-KAEK-02082021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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