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Assessing Lung Inhomogeneity During Ventilation for Acute Hypoxemic Respiratory Failure (ALIVE)

Primary Purpose

Acute Respiratory Distress Syndrome, Mechanical Ventilation Pressure High, Hypoxemic Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Electrical Impedance Tomography
ExPRESS-derived PEEP level
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Acute (≤7 days) hypoxemia with PaO2:FiO2 ratio less than or equal to 200 mm Hg
  • Oral endotracheal intubation and mechanical ventilation
  • Bilateral airspace opacities on chest radiograph or CT

Exclusion Criteria:

  • Contraindication to EIT electrode placement (burns, chest wall bandaging limiting electrode placement)
  • Contraindication to esophageal catheter placement (recent upper GI surgery, actively bleeding esophageal varices)
  • Respiratory failure predominantly due to cardiogenic cause or fluid overload
  • Ongoing hemodynamic instability (requiring 2 vasopressor agents by continuous infusion AND rising vasopressor infusion rate requirements in the previous 8 hours)
  • Ongoing ventilatory instability (P/F < 70 mm Hg, pH < 7.2; ventilator driving pressures, PEEP, or FiO2 increasing by more than 25% in previous 30 minutes)
  • Intracranial hypertension (suspected or diagnosed by medical team)
  • Known or suspected pneumothorax recognized within previous 72 hours
  • Bronchopleural fistula
  • Bridge to lung transplant
  • Recent lung transplantation (within previous 6 weeks)
  • Attending physician deems the transient application of high airway pressures (>40 cm H2O) to be unsafe

Sites / Locations

  • University Health Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EIT algorithm

ExPRESS algorithm

Arm Description

Patients randomized to this arm will be ventilated at the PEEP level selected by the EIT algorithm, which selects a PEEP at which both collapse and hyperdistention are minimized.

Patients randomized to this arm will be ventilated at the PEEP level selected by the ExPRESS algorithm, which is a method that targets a tidal volume of 6 ml/kg predicted body weight and then titrates PEEP until plateau airway pressure reaches 28 cm H2O.

Outcomes

Primary Outcome Measures

Intratidal ventilation heterogeneity
A measure of variation in the distribution of ventilation throughout the lung as detected by electrical impedance tomography

Secondary Outcome Measures

Difference in the optimal PEEP levels identified by several different PEEP titration strategies
Compare the relative degree of agreement or disparity between PEEP levels recommended by different PEEP titration strategies
Change in ratio of partial pressure of oxygen (PaO2) to inspired fraction of oxygen (FiO2) ratio following a standardized increased in PEEP
Measurement of changes in oxygenation by PaO2/FiO2 ratio due to PEEP
Respiratory mechanics (transpulmonary driving pressure)
The swing in transpulmonary pressure during inspiration, a measure of dynamic lung stress

Full Information

First Posted
April 6, 2018
Last Updated
September 27, 2021
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03589482
Brief Title
Assessing Lung Inhomogeneity During Ventilation for Acute Hypoxemic Respiratory Failure
Acronym
ALIVE
Official Title
Assessing Lung Inhomogeneity During Ventilation for Acute Hypoxemic Respiratory Failure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Mechanical ventilation can cause damage by overstretching the lungs, especially when the lungs are collapsed or edematous. Raising ventilator pressures can reduce lung collapse and this can prevent overstretching from mechanical ventilation. It remains uncertain how much pressure (PEEP - positive end-expiratory pressure) should be used on the ventilator and how to identify patients who will benefit from higher ventilator pressures vs. lower ventilator pressures. The investigators are using a unique new imaging technology, electrical impedance tomography (EIT), to study this problem and to determine the safest and most effective ventilator pressure level. The results of this study will inform future trials of higher vs. lower PEEP strategies in mechanically ventilated patients.
Detailed Description
Patients participating in this physiological cross-over randomized trial will undergo a series of PEEP maneuvers designed to assess lung recruitability, PEEP responsiveness, and optimal PEEP. EIT imaging and esophageal manometry will be employed throughout the protocol to quantify the effect of PEEP on lung function. Patients will be randomized to be ventilated at PEEP levels supplied by the ExPRESS strategy or by the EIT hyperdistention/collapse algorithm. The biological response will be assessed by measuring serum cytokines.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome, Mechanical Ventilation Pressure High, Hypoxemic Respiratory Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EIT algorithm
Arm Type
Experimental
Arm Description
Patients randomized to this arm will be ventilated at the PEEP level selected by the EIT algorithm, which selects a PEEP at which both collapse and hyperdistention are minimized.
Arm Title
ExPRESS algorithm
Arm Type
Active Comparator
Arm Description
Patients randomized to this arm will be ventilated at the PEEP level selected by the ExPRESS algorithm, which is a method that targets a tidal volume of 6 ml/kg predicted body weight and then titrates PEEP until plateau airway pressure reaches 28 cm H2O.
Intervention Type
Device
Intervention Name(s)
Electrical Impedance Tomography
Intervention Description
Electrical impedance tomography (EIT) is a new technique that enables real-time visualization of the distribution of ventilation at the bedside. This technique allows clinicians and investigators to immediately determine how applying higher or lower PEEP levels affect stress and strain in the lung. The investigators propose to apply this new technique to test a strategy for finding the optimal level of PEEP that prevents lung injury and improves outcomes in critically ill patients.
Intervention Type
Other
Intervention Name(s)
ExPRESS-derived PEEP level
Intervention Description
The ExPRESS algorithm is a traditional approach to selecting PEEP based on respiratory mechanics.
Primary Outcome Measure Information:
Title
Intratidal ventilation heterogeneity
Description
A measure of variation in the distribution of ventilation throughout the lung as detected by electrical impedance tomography
Time Frame
Assessed after completion of 3 hours on randomized strategy (EIT vs ExPRESS)
Secondary Outcome Measure Information:
Title
Difference in the optimal PEEP levels identified by several different PEEP titration strategies
Description
Compare the relative degree of agreement or disparity between PEEP levels recommended by different PEEP titration strategies
Time Frame
Assessed immediately after completion of decremental PEEP titration procedure
Title
Change in ratio of partial pressure of oxygen (PaO2) to inspired fraction of oxygen (FiO2) ratio following a standardized increased in PEEP
Description
Measurement of changes in oxygenation by PaO2/FiO2 ratio due to PEEP
Time Frame
Assessed 10 minutes after step PEEP increase from 6-8 to 16-18 cm H2O
Title
Respiratory mechanics (transpulmonary driving pressure)
Description
The swing in transpulmonary pressure during inspiration, a measure of dynamic lung stress
Time Frame
Assessed after completing 3 hours on the randomized PEEP strategy (EIT vs ExPRESS)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute (≤7 days) hypoxemia with PaO2:FiO2 ratio less than or equal to 200 mm Hg Oral endotracheal intubation and mechanical ventilation Bilateral airspace opacities on chest radiograph or CT Exclusion Criteria: Contraindication to EIT electrode placement (burns, chest wall bandaging limiting electrode placement) Contraindication to esophageal catheter placement (recent upper GI surgery, actively bleeding esophageal varices) Respiratory failure predominantly due to cardiogenic cause or fluid overload Ongoing hemodynamic instability (requiring 2 vasopressor agents by continuous infusion AND rising vasopressor infusion rate requirements in the previous 8 hours) Ongoing ventilatory instability (P/F < 70 mm Hg, pH < 7.2; ventilator driving pressures, PEEP, or FiO2 increasing by more than 25% in previous 30 minutes) Intracranial hypertension (suspected or diagnosed by medical team) Known or suspected pneumothorax recognized within previous 72 hours Bronchopleural fistula Bridge to lung transplant Recent lung transplantation (within previous 6 weeks) Attending physician deems the transient application of high airway pressures (>40 cm H2O) to be unsafe
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ewan Goligher, MD, PhD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33784416
Citation
Santa Cruz R, Villarejo F, Irrazabal C, Ciapponi A. High versus low positive end-expiratory pressure (PEEP) levels for mechanically ventilated adult patients with acute lung injury and acute respiratory distress syndrome. Cochrane Database Syst Rev. 2021 Mar 30;3(3):CD009098. doi: 10.1002/14651858.CD009098.pub3.
Results Reference
derived

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Assessing Lung Inhomogeneity During Ventilation for Acute Hypoxemic Respiratory Failure

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