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

NCT ID: NCT03612583

Last Updated: 2024-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2022-11-30

Brief 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.

Detailed 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.

Conditions

Diaphragm Injury; Lung Injury; Respiratory Insufficiency; Mechanical Ventilation Complication

Keywords

Diaphragm Dysfunction; Acute Respiratory Failure; Sedation; Mechanical Ventilation; Lung Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Lower PEEP

Lung- and Diaphragm-Protective Ventilation - PEEP will be set at 8 cm H2O

Group Type: EXPERIMENTAL

Lung- and Diaphragm-Protective Ventilation

Intervention Type: 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.

Higher PEEP

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

Group Type: EXPERIMENTAL

Lung- and Diaphragm-Protective Ventilation

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

LDPV

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ewan Goligher, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

University Health Network

Toronto, Ontario, Canada

Countries

Canada

References

Dianti J, Fard S, Wong J, Chan TCY, Del Sorbo L, Fan E, Amato MBP, Granton J, Burry L, Reid WD, Zhang B, Ratano D, Keshavjee S, Slutsky AS, Brochard LJ, Ferguson ND, Goligher EC. Strategies for lung- and diaphragm-protective ventilation in acute hypoxemic respiratory failure: a physiological trial. Crit Care. 2022 Aug 29;26(1):259. doi: 10.1186/s13054-022-04123-9.

Reference Type: DERIVED

PMID: 36038890 (View on PubMed)

Other Identifiers

18-5644

Identifier Type: -

Identifier Source: org_study_id