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Mechanical Ventilation ComplicationNCT05127317

Mechanical Power in Pediatric Mechanical Ventilation

An observational study of Mechanical Ventilation Complication and Aediatric Anesthesia, run by Bozok University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 0 to 18 yearsHealthy volunteers can take part
What is being tested?
Mechanical power
How many people
34 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Aug 2021to 10 Jan 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

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

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Bozok Univesity Hospital

    Yozgat, 66001

Other trials in Turkey (Türkiye)

About this study

Official title: 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

Read the 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.

Being tested
Mechanical power
Keywords
mechanical ventilation, pediatric anesthesia, mechanical power

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mechanical powerDiagnostic test

    In our study, mechanical power (MP) will be calculated during mechanical ventilation in patients who will be operated under general anesthesia.

    MP will be calculated with the simplified formula applied by Gattinoni et al. MPvcv: RR x Tv x (PIP-[(Pplat-PEEP)/2]) x 0.098(2) In pressure-controlled ventilation, the simplified MP formula of Becher et al. well be used.

    MPpcv: RR x Tv x (ΔPinsp + PEEP) x 0.098 (11)

    For MP calculated according to the weight of the patients; Indexed MP: MP /kg according to IBW. For the force applied to the lungs in each inspiration; Dynamic power (mJ/min): Vt x RR x [(Pplato+ tPEEP)/2]. For the driver power that provides the gas flow; Driving power (mJ/min): Vt x RR x [ (Pplat - tPEEP) / 2]. Calculating mechanical energy; Mechanical energy (mJ/kg): 0.098 x (V x kg ) x (PIP - [(P plateau- PEEP) / 2]) formulas were used

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. median mechanical power

    mechanical force applied to the lungs during mechanical ventilation, calculated according to the formula

    Measured: Measurements will be taken after half an hour of mechanical ventilation.

Secondary outcomes (1)
  1. indexed mechanical power

    mechanical power and other mechanical ventilator parameters applied according to the weight of the patients

    Measured: Data will be obtained at the beginning of the operation and after half an hour of ventilation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2021
  2. Study start10 Aug 2021
  3. Primary completion10 Dec 2021
  4. Study completion10 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05127317
Sponsor's protocol ID
2017-KAEK-02082021
Status last verified
Jul 2022
First submitted
12 Nov 2021
Last updated
11 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kneyber MCJ. Driving Pressure and Mechanical Power: The Return of Physiology in Pediatric Mechanical Ventilation. Pediatr Crit Care Med. 2021 Oct 1;22(10):927-929. doi: 10.1097/PCC.0000000000002829. No abstract available.

    PubMed 34605787
  • Becher T, van der Staay M. Calculation of mechanical power for pressure-controlled ventilation: author's reply. Intensive Care Med. 2019 Oct;45(10):1498-1499. doi: 10.1007/s00134-019-05742-7. Epub 2019 Aug 20. No abstract available.

    PubMed 31432217

Questions about this trial

What is this clinical trial studying?

An observational study of Mechanical Ventilation Complication and Aediatric Anesthesia, run by Bozok University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

median mechanical power (time frame: Measurements will be taken after half an hour of mechanical ventilation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05127317, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.

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