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

NCT03612583 | Completed Phase 1

• 1 other identifier: 18-5644
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Rate of patients achieving and maintaining LDPV targets

  Assessed after achievement of LDPV targets for 24 hours

Secondary Outcomes (6)

• Inspiratory effort at lower and higher PEEP levels

  Assessed 10 minutes after PEEP and sedation are adjusted

• Expiratory diaphragmatic effort at lower and higher PEEP levels

  Assessed 10 minutes after PEEP and sedation are adjusted

• Lung stress and strain at low and high sweep gas flow rates

  Assessed 10 minutes after PEEP and sedation are adjusted

• Inspiratory effort at low and high sweep gas flow rates

  Assessed 10 minutes after PEEP and sedation are adjusted

• Sedative infusion rate at low and high sweep gas flow rates

  Assessed 10 minutes after PEEP and sedation are adjusted

Study Arms (2)

Lower PEEP

EXPERIMENTAL

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

Procedure: Lung- and Diaphragm-Protective Ventilation

Higher PEEP

EXPERIMENTAL

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

Procedure: Lung- and Diaphragm-Protective Ventilation

Interventions

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.

Also known as: LDPV

Higher PEEP; Lower PEEP

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2N2, Canada

Location

Related Publications (1)

• 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.

  PMID: 36038890 DERIVED

MeSH Terms

Conditions

Lung Injury; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries; Respiration Disorders

Study Officials

• Ewan Goligher, MD, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: August 2, 2018
• Study Start: February 1, 2019
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)