ClinicalTrials.Veeva

Menu

Lung and Diaphragm-Protective Ventilation by Means of Assessing Respiratory Work (LANDMARK)

University Health Network, Toronto logo

University Health Network, Toronto

Status

Completed

Conditions

Lung Injury
Mechanical Ventilation Complication
Respiratory Insufficiency
Diaphragm Injury

Treatments

Procedure: Lung- and Diaphragm-Protective Ventilation

Study type

Interventional

Funder types

Other

Identifiers

NCT03612583
18-5644

Details and patient eligibility

About

This study is designed to test a proposed strategy for lung- and diaphragm-protective ventilation (LDPV) in patients with acute hypoxemic respiratory failure. Ventilation and sedation will be titrated to evaluate whether it is feasible and safe within this patient population.

Full description

Lung injury and diaphragm injury incurred by mechanical ventilation have very serious adverse effects on patients with acute respiratory failure. Lung injury results from excessive mechanical stress and strain applied to the lung by the ventilator and/or respiratory muscles, while diaphragm injury results from either insufficient or excessive inspiratory effort.

The objective of this study is to investigate a new LDPV strategy designed to prevent both disuse-mediated and load-induced diaphragm injury, while also preventing excess global and regional mechanical stress and strain in the injured lung. To achieve these goals, the following specific targets to be met are: (1) respiratory muscle effort similar to that of healthy subjects breathing at rest, (2) lung stress within safe limits, and (3) clinically acceptable gas exchange.

Targets are assessed through measurements of global lung stress, tidal recruitment, inspiratory effort, diaphragm contractile effort and adequacy of respiratory muscle and systemic tissue perfusion. Measurements commence at enrollment and continue for 24 hours consecutively.

Enrollment

23 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosed with acute hypoxemic respiratory failure
  • PaO2:FiO2 ratio less than or equal to 300 mm Hg at time of screening
  • Oral endotracheal intubation and mechanical ventilation
  • Bilateral airspace opacities on chest radiograph or chest CT scan

Exclusion criteria

  • Liberation from mechanical ventilation is anticipated within 24 hours
  • Intubated for traumatic brain injury or stroke
  • Contraindication to esophageal catheterization
  • Intracranial hypertension

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

23 participants in 2 patient groups

Lower PEEP
Experimental group
Description:
Lung- and Diaphragm-Protective Ventilation - PEEP will be set at 8 cm H2O
Treatment:
Procedure: Lung- and Diaphragm-Protective Ventilation
Higher PEEP
Experimental group
Description:
Lung- and Diaphragm-Protective Ventilation - PEEP will be titrated to achieve end-expiratory PL = 2-3 cm H20 and at least 5 cm H2O greater than the level applied in the lower PEEP arm
Treatment:
Procedure: Lung- and Diaphragm-Protective Ventilation

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems