RECRUITING

Precision Ventilation vs Standard Care for Acute Respiratory Distress Syndrome

Conditions

Acute Respiratory Distress Syndrome Respiratory Failure critical care critical illness esophageal manometry transpulmonary pressure mechanical ventilation lung stress

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this interventional study is to compare standard mechanical ventilation to a lung-stress oriented ventilation strategy in patients with Acute Respiratory Distress Syndrome (ARDS). Participants will be ventilated according to one of two different strategies. The main question the study hopes to answer is whether the personalized ventilation strategy helps improve survival.

Official Title

PREcision VENTilation to Attenuate Ventilator-Induced Lung Injury: A Phase 3 Multicenter Randomized Clinical Trial

Quick Facts

Study Start:2024-06-24

Study Completion:2030-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06066502

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age ≥ 18 years 2. Moderate or severe ARDS, defined as meeting all of the following (a-e): 1. Invasive ventilation with positive end-expiratory pressure (PEEP) ≥ 5 cm H2O 2. Hypoxemia as characterized by: If arterial blood gas (ABG) available: the partial pressure of oxygen in the arterial blood (PaO2)/FiO2 ≤ 200 mm Hg, or, if ABG not available OR overt clinical deterioration in oxygenation since last ABG: SpO2/FiO2 ≤ 235 with SpO2 ≤ 97% (both conditions) on two representative assessments between 1 to 6 hours apart 3. Bilateral lung opacities on chest imaging not fully explained by effusions, lobar collapse, or nodules 4. Respiratory failure not fully explained by heart failure or fluid overload 5. Onset within 1 week of clinical insult or new/worsening symptoms 3. Early in ARDS course * Within 48 hours since meeting last moderate-severe ARDS criterion (#2 above) * Current invasive ventilation episode not more than 4 days duration * Current severe hypoxemic episode (receipt of invasive ventilation, noninvasive ventilation, or high-flow nasal cannula) not more than 10 days duration	1. Esophageal manometry used clinically 2. Severe brain injury: including suspected elevated intracranial pressure, cerebral edema, or Glasgow coma score (GCS) ≤ 8 directly caused by severe brain injury (e.g., ischemia/hemorrhage). 3. Gross barotrauma or chest tube inserted to treat barotrauma 4. Esophageal varix or stricture; recent oropharyngeal or gastroesophageal surgery; or past esophagectomy 5. Severe coagulopathy (platelet \< 5000/µL or international normalized ratio \[INR\] \> 4) 6. Extracorporeal membrane oxygenation or carbon dioxide (CO2) removal 7. Neuromuscular disease that impairs spontaneous breathing (including but not limited to amyotrophic lateral sclerosis, Guillain-Barré syndrome, spinal cord injury at C5 or above) 8. Chronic supplemental oxygen, pulmonary fibrosis, or lung transplant 9. Refractory shock: norepinephrine-equivalent dose ≥ 0.4 µg/kg/min or simultaneous receipt of ≥ 3 vasopressors 10. Severe liver disease, defined as Child-Pugh Class C 11. ICU admission for burn injury 12. Current ICU stay \> 2 weeks or hospital stay (including subacute hospitalization) \> 4 weeks 13. Estimated mortality \> 50% over 6 months due to underlying chronic medical condition as assessed by the study physician 14. Moribund patient not expected to survive 24 hours as assessed by the study physician; if cardiopulmonary resuscitation (CPR) was provided, assessment for moribund status must occur at least 6 hours after CPR was completed 15. Limitation on life-sustaining care, other than do-not-resuscitate, or expectation by treating clinical team that a limitation on life-sustained care will be adopted within next 24 hours. 16. Treating clinician refusal 17. Prisoner

Inclusion Criteria

Exclusion Criteria

1. Age ≥ 18 years
2. Moderate or severe ARDS, defined as meeting all of the following (a-e):
1. Invasive ventilation with positive end-expiratory pressure (PEEP) ≥ 5 cm H2O
2. Hypoxemia as characterized by: If arterial blood gas (ABG) available: the partial pressure of oxygen in the arterial blood (PaO2)/FiO2 ≤ 200 mm Hg, or, if ABG not available OR overt clinical deterioration in oxygenation since last ABG: SpO2/FiO2 ≤ 235 with SpO2 ≤ 97% (both conditions) on two representative assessments between 1 to 6 hours apart
3. Bilateral lung opacities on chest imaging not fully explained by effusions, lobar collapse, or nodules
4. Respiratory failure not fully explained by heart failure or fluid overload
5. Onset within 1 week of clinical insult or new/worsening symptoms
3. Early in ARDS course
* Within 48 hours since meeting last moderate-severe ARDS criterion (#2 above)
* Current invasive ventilation episode not more than 4 days duration
* Current severe hypoxemic episode (receipt of invasive ventilation, noninvasive ventilation, or high-flow nasal cannula) not more than 10 days duration

1. Esophageal manometry used clinically
2. Severe brain injury: including suspected elevated intracranial pressure, cerebral edema, or Glasgow coma score (GCS) ≤ 8 directly caused by severe brain injury (e.g., ischemia/hemorrhage).
3. Gross barotrauma or chest tube inserted to treat barotrauma
4. Esophageal varix or stricture; recent oropharyngeal or gastroesophageal surgery; or past esophagectomy
5. Severe coagulopathy (platelet \< 5000/µL or international normalized ratio \[INR\] \> 4)
6. Extracorporeal membrane oxygenation or carbon dioxide (CO2) removal
7. Neuromuscular disease that impairs spontaneous breathing (including but not limited to amyotrophic lateral sclerosis, Guillain-Barré syndrome, spinal cord injury at C5 or above)
8. Chronic supplemental oxygen, pulmonary fibrosis, or lung transplant
9. Refractory shock: norepinephrine-equivalent dose ≥ 0.4 µg/kg/min or simultaneous receipt of ≥ 3 vasopressors
10. Severe liver disease, defined as Child-Pugh Class C
11. ICU admission for burn injury
12. Current ICU stay \> 2 weeks or hospital stay (including subacute hospitalization) \> 4 weeks
13. Estimated mortality \> 50% over 6 months due to underlying chronic medical condition as assessed by the study physician
14. Moribund patient not expected to survive 24 hours as assessed by the study physician; if cardiopulmonary resuscitation (CPR) was provided, assessment for moribund status must occur at least 6 hours after CPR was completed
15. Limitation on life-sustaining care, other than do-not-resuscitate, or expectation by treating clinical team that a limitation on life-sustained care will be adopted within next 24 hours.
16. Treating clinician refusal
17. Prisoner

Contacts and Locations

Study Contact

Valerie Goodspeed, MPH

CONTACT

6176328055

vgoodspe@bidmc.harvad.edu

Nancy Ringwood, RN

CONTACT

617-724-9836

nringwood@mgh.harvard.edu

Principal Investigator

Daniel Talmor, MD MPH

PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Study Locations (Sites)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

Columbia University Medical Center

New York, New York, 10032

United States

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

Daniel Talmor, MD MPH, PRINCIPAL_INVESTIGATOR, Beth Israel Deaconess Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-24

Study Completion Date2030-08-31

Study Record Updates

Study Start Date2024-06-24

Study Completion Date2030-08-31

Terms related to this study

Keywords Provided by Researchers

critical care
critical illness
esophageal manometry
transpulmonary pressure
mechanical ventilation
lung stress

Additional Relevant MeSH Terms

Acute Respiratory Distress Syndrome
Respiratory Failure