Skip to main content
OpenTrials
Completed

NCT Number: NCT03612583

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Health Network

Toronto, Ontario, M5G 2N2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lung- and Diaphragm-Protective Ventilation

Procedure

Ventilation and sedation will be progressively modified according to the LDPV algorithm to achieve targets. Patients will be crossed-over to the opposite PEEP strategy. LDPV titration will then be repeated to achieve LDPV targets. After establishing a combination of ventilation and sedation settings at which LDPV targets are achieved, the targets will be maintained over a 24-hour period.

Other names: LDPV

Primary outcomes

  1. Rate of patients achieving and maintaining LDPV targets

    Time frame: Assessed after achievement of LDPV targets for 24 hours

Secondary outcomes

  1. Inspiratory effort at lower and higher PEEP levels

    Time frame: Assessed 10 minutes after PEEP and sedation are adjusted

  2. Expiratory diaphragmatic effort at lower and higher PEEP levels

    Time frame: Assessed 10 minutes after PEEP and sedation are adjusted

  3. Lung stress and strain at low and high sweep gas flow rates

    Time frame: Assessed 10 minutes after PEEP and sedation are adjusted

  4. Inspiratory effort at low and high sweep gas flow rates

    Time frame: Assessed 10 minutes after PEEP and sedation are adjusted

  5. Sedative infusion rate at low and high sweep gas flow rates

    Time frame: Assessed 10 minutes after PEEP and sedation are adjusted

  6. Accuracy of artificial intelligence model in predicting patient outcomes

    Time frame: Assessed after completing the 24-hour maintenance period

    We will compare the model's prediction of patient's esophageal pressure, pH and transpulmonary pressure to the actual observed values

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Acronym: LANDMARK

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 2, 2018
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.