NCT05127317

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 19, 2021

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2022

Completed
Last Updated

July 11, 2022

Status Verified

July 1, 2022

Enrollment Period

4 months

First QC Date

November 12, 2021

Last Update Submit

July 8, 2022

Conditions

Keywords

mechanical ventilationpediatric anesthesiamechanical power

Outcome Measures

Primary Outcomes (1)

  • median mechanical power

    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 Outcomes (1)

  • indexed mechanical power

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

Interventions

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

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bozok Univesity Hospital

Yozgat, 66001, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

  • 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.

Study Officials

  • Ahmet YUKSEK, asst.prof

    Yozgat Bozok Universitesi

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst.Prof.Dr.

Study Record Dates

First Submitted

November 12, 2021

First Posted

November 19, 2021

Study Start

August 10, 2021

Primary Completion

December 10, 2021

Study Completion

January 10, 2022

Last Updated

July 11, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations