Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03612583
Other study ID # 18-5644
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05904652 - High Flow Nasal Oxygen at Extubation for Adults Requiring a Breathing Tube for Treating Severe Breathing Difficulties N/A
Completed NCT04030208 - Evaluating Safety and Efficacy of Umbulizer in Patients Requiring Intermittent Positive Pressure Ventilation N/A
Recruiting NCT03697785 - Weaning Algorithm for Mechanical VEntilation N/A
Recruiting NCT02989051 - Fluid Restriction Keeps Children Dry Phase 2/Phase 3
Completed NCT02930525 - Effect of High Flow Nasal Cannula vs. Standard Care on Respiratory Stability in Pediatric Procedural Sedation N/A
Recruiting NCT02539732 - Prediction of Outcome of Weaning From Mechanical Ventilation Using the Electrical Activity of the Diaphragm
Enrolling by invitation NCT02290236 - Monitored Saturation Post-ICU N/A
Completed NCT02056119 - RCT of Mesh Versus Jet Nebulizers on Clinical Outcomes During Mechanical Ventilation in the Intensive Care Unit N/A
Terminated NCT01583088 - Early Stage Amyotrophic Lateral Sclerosis Phrenic Stimulation Phase 3
Withdrawn NCT00990119 - High Flow Therapy (HFT) to Treat Respiratory Insufficiency in Chronic Obstructive Pulmonary Disease (COPD) N/A
Completed NCT00741949 - Broncho-alveolar Lavage Under Noninvasive Ventilation With Propofol TCI in Patient With AHRF Phase 3
Completed NCT01411722 - Electrical Activity of the Diaphragm During the Weaning Period Phase 2
Recruiting NCT00339053 - Immunonutrition and Thoracoabdominal Aorta Aneurysm Repair Phase 4
Recruiting NCT00187434 - Comparison of Two Methods of Continuous Positive Airway Pressure (CPAP) to Support Successful Extubation of Infants of Birth Weights ≤ 1500 Grams (C2CPAP) N/A
Completed NCT02687802 - Respiratory Mechanics and Patient-ventilator Asynchrony Index in Patients With Invasive Mechanical Ventilation
Not yet recruiting NCT05906030 - Diaphragm Dysfunction and Ultrasound Perioperatively
Completed NCT03850977 - Is There an Association Between Chronic Pancreatitis and Pulmonary Function
Completed NCT02845375 - Effect of Neuromuscular Blockade and Reversal on Breathing Phase 4
Recruiting NCT03309423 - Is Venous to Arterial Conversion (v-TAC) of Blood Gas Reliable in Critical Ill Patients in the ICU? N/A
Completed NCT04115969 - Outcome After Non-invasive Ventilation.