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

Respiratory Insufficiency Clinical Trial

— LANDMARK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03612583
• Other study ID #: 18-5644
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: November 30, 2022

Study information

• Verified date: April 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diaphragm Injury
• Lung Injury
• Mechanical Ventilation Complication
• Respiratory Insufficiency
• Wounds and Injuries

Intervention

Procedure:
• Lung- and Diaphragm-Protective Ventilation
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.

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients achieving and maintaining LDPV targets		Assessed after achievement of LDPV targets for 24 hours
Secondary	Inspiratory effort at lower and higher PEEP levels		Assessed 10 minutes after PEEP and sedation are adjusted
Secondary	Expiratory diaphragmatic effort at lower and higher PEEP levels		Assessed 10 minutes after PEEP and sedation are adjusted
Secondary	Lung stress and strain at low and high sweep gas flow rates		Assessed 10 minutes after PEEP and sedation are adjusted
Secondary	Inspiratory effort at low and high sweep gas flow rates		Assessed 10 minutes after PEEP and sedation are adjusted
Secondary	Sedative infusion rate at low and high sweep gas flow rates		Assessed 10 minutes after PEEP and sedation are adjusted
Secondary	Accuracy of artificial intelligence model in predicting patient outcomes	We will compare the model's prediction of patient's esophageal pressure, pH and transpulmonary pressure to the actual observed values	Assessed after completing the 24-hour maintenance period