Specific Mechanical Power Assessment in Patients With Acute Respiratory Distress Syndrome

NCT05410262 | Completed

• 1 other identifier: El Cruce
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

In ARDS patients, mechanical ventilation should minimize ventilator-induced lung injury. The mechanical power which is the energy per unit time released to the respiratory system according to the applied tidal volume, PEEP, respiratory rate, and flow should reflect the ventilator-induced lung injury

Conditions

Ventilation, Mechanical

Keywords

ARDS; Mechanical power

Outcome Measures

Primary Outcomes (5)

• specific mechanical power

  Specific mechanical power was calculated as the ratio of mechanical power to ventilable lung volume.

  "immediately after the intervention/procedure/surgery"

• relationship between lung load and severity of ARDS

  relationship between specific mechanical power and severity of ARDS

  "immediately after the intervention/procedure/surgery"

• relationship between lung load and elastance of ARDS

  relationship between specific mechanical power and elastance of ARDS

  "immediately after the intervention/procedure/surgery"

• relationship between lung load and strain

  relationship between specific mechanical power and strain

  "immediately after the intervention/procedure/surgery"

• relationship between lung load and atelectrauma

  relationship between specific mechanical power and atelectrauma

  "immediately after the intervention/procedure/surgery"

Study Arms (1)

Mechanical power and risk of ventilator-induced lung injury in patients with ARDS

This study will prospectively evaluate patients consecutively admitted with ARDS, as defined according to the Berlin expert consensus

Other: Evaluation of CT images

Interventions

Evaluation of CT images OTHER

A helicoidal CT scanner will be used (Aquilion CXL, Toshiba, Japan), with AIDR 3D technique (Adaptive Iterative Dose Reduction 3D) in order to minimize exposure to X-rays. Two complete thorax CT scans will be performed, one of them in expiratory pause (PEEP) and the other in inspiratory pause (PPlat). Esophageal pressure shall be measured (FluxMed GrT, Argentina) and transpulmonary pressure will be calculated at the end of inspiration (Ppl-insp) and expiration (Ppl-exp).

Also known as: Evaluation of transpulmonary pressures

Mechanical power and risk of ventilator-induced lung injury in patients with ARDS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients consecutively admitted with ARDS, as defined according to the Berlin expert consensus

Sponsors & Collaborators

• Hospital El Cruce: lead

Study Sites (1)

Hospital de Alta Complejidad en Red El Cruce Nestor C. Kirchner

San Juan Bautista, Buenos Aires, 1888, Argentina

Location

Related Publications (5)

• Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.

  PMID: 27620287 BACKGROUND

• Cressoni M, Gotti M, Chiurazzi C, Massari D, Algieri I, Amini M, Cammaroto A, Brioni M, Montaruli C, Nikolla K, Guanziroli M, Dondossola D, Gatti S, Valerio V, Vergani GL, Pugni P, Cadringher P, Gagliano N, Gattinoni L. Mechanical Power and Development of Ventilator-induced Lung Injury. Anesthesiology. 2016 May;124(5):1100-8. doi: 10.1097/ALN.0000000000001056.

  PMID: 26872367 BACKGROUND

• Costa ELV, Slutsky AS, Brochard LJ, Brower R, Serpa-Neto A, Cavalcanti AB, Mercat A, Meade M, Morais CCA, Goligher E, Carvalho CRR, Amato MBP. Ventilatory Variables and Mechanical Power in Patients with Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2021 Aug 1;204(3):303-311. doi: 10.1164/rccm.202009-3467OC.

  PMID: 33784486 BACKGROUND

• Coppola S, Caccioppola A, Froio S, Formenti P, De Giorgis V, Galanti V, Consonni D, Chiumello D. Effect of mechanical power on intensive care mortality in ARDS patients. Crit Care. 2020 May 24;24(1):246. doi: 10.1186/s13054-020-02963-x.

  PMID: 32448389 BACKGROUND

• Gattinoni L, Marini JJ, Collino F, Maiolo G, Rapetti F, Tonetti T, Vasques F, Quintel M. The future of mechanical ventilation: lessons from the present and the past. Crit Care. 2017 Jul 12;21(1):183. doi: 10.1186/s13054-017-1750-x.

  PMID: 28701178 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nestor Pistillo

  Hospital El Cruce

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Intensive Care Unit al Hospital El Cruce

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 8, 2022
• Study Start: July 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: December 30, 2022
• Last Updated: March 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)