High Frequency Oscillatory Ventilation for Acute Respiratory Distress Syndrome (ARDS)
This study is currently recruiting participants.
Verified January 2013 by University of Athens
Sponsor:
University of Athens
Collaborator:
University of Thessaly
Information provided by (Responsible Party):
Spyros D. Mentzelopoulos, University of Athens
ClinicalTrials.gov Identifier:
NCT01478802
First received: November 21, 2011
Last updated: January 23, 2013
Last verified: January 2013
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Purpose
Based on recent two-center results (Eur Respir J. 2011 Sep 1. [Epub ahead of print] PMID: 21885390) we hypothesized that intermittent High-frequency oscillation (HFO) combined with Recruitment Maneuvers (RMs) may beneficially affect the pathophysiology and survival of patients with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS).
Design: Randomized Controlled Trial. Intervention: Briefly, the HFO-RMs strategy of the intervention (HFO-RMs) group will comprise RMs (3/day) and an initial HFO session of 96 hours (HFO session can be interrupted before the 96-hour time point only if PaO2/FiO2 rises to >200 mmHg for >12 hours), followed by return to lung protective conventional mechanical ventilation (CMV) according to pre-specified oxygenation criteria. Within days 1-10 postrandomization, patients will be returned to HFO upon recurrence of their moderate-to-severe oxygenation disturbance. Patients of the control (CMV) group will receive lung protective CMV.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Respiratory Distress Syndrome |
Device: Lung protective CMV Device: HFO-RMs |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of Intermittent High Frequency Oscillatory Ventilation on the Pathophysiology and Survival of Patients With the Acute Respiratory Distress Syndrome. |
Resource links provided by NLM:
Further study details as provided by University of Athens:
Primary Outcome Measures:
- Survival to hospital discharge [ Time Frame: 60-120 days ] [ Designated as safety issue: No ]Patient discharged home while not requiring any form of ventilatory assistance.
Secondary Outcome Measures:
- The number of ventilator-free days until day 60 post-randomization [ Time Frame: 60 days ] [ Designated as safety issue: No ]"60 minus days on ventilator until day 60 postrandomization"
- The number of organ failure-free days until day 60 post-randomization [ Time Frame: 60 days ] [ Designated as safety issue: No ]"60 minus the days with an organ failure until day 60 postrandomization"
- Complications [ Time Frame: 60-120 days ] [ Designated as safety issue: Yes ]Ventilation-related (e.g. barotrauma); Recruitment Maneuver-related (e.g. hypotension or desaturation); Tracheal Gas Insufflation-related (e.g. tracheal mucosal damage)
- Physiological variables during the study intervention period [ Time Frame: 10 days ] [ Designated as safety issue: No ]Evolution of Physiological variables during the first 10 days post-randomization {comparison of gas-exchange, respiratory mechanics (14), hemodynamics, fluid balance of preceding 24 hours, and blood lactate; all between-group-compared variables to be concurrently determined within 8.30 to 9.00 a.m. of each one of the first 10 days post-randomization}
- Inflammatory response [ Time Frame: 5 days ] [ Designated as safety issue: No ]Determination of markers of inflammation (cytokines and Activin A) in bronchoalveolar lavage fluid and peripheral blood at baseline and on day 5 post-randomization. Additional determination of surfactant activity on the same time points.
| Estimated Enrollment: | 204 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: CMV Arm
Patients with moderate-to-severe Acute Respiratory Distress Syndrome treated solely with lung protective, low volume high positive end-expiratory pressure conventional mechanical ventilation (CMV) and recruitment maneuvers, as specified in detail in the Detailed Description section.
|
Device: Lung protective CMV
Low tidal volume-high positive end-expiratory pressure conventional mechanical ventilation (CMV) and recruitment maneuvers, as specified in detail in the Detailed Description Section.
|
|
Experimental: HFO-RMs Arm
Patients with moderte-to-severe Acute Respiratory Distress Syndrome treated initially with a 96-hour-lasting session (session duration modifiable according to oxygenation criteria) of High-frequency oscillation (HFO)-Recruitment Maneuvers (RMs), and then with lung protective CMV interspersed to additional HFO-RMs sessions (if required according to study protocol). The protocolized use of HFO-RMs may extend until day 10 post-randomization, according to pre-specified oxygenation criteria. Full details are provided in the Detailed Description Section.
|
Device: HFO-RMs
Initial, 96-hour-lasting session (session duration modifiable according to oxygenation criteria) of High-frequency oscillation (HFO) combined with recruitment Maneuvers (RMs), followed by additional HFO-RMs sessions (if required according to the study protocol oxygenation criteria)during days 1-10. During the rest of the intervention period, patients will be treated with the same lung protective CMV strategy of the CMV arm. Additional details are provided in the Detailed Description Section.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- early ARDS (establishment of the diagnosis within the preceding 72 hours) according to the criteria of the American-European Consensus Conference (5),
- Moderate-to-severe oxygenation disturbance [defined as ratio of partial pressure of arterial oxygen (PaO2) to inspired oxygen fraction (FiO2)<200 mmHg, while being ventilated with positive end-expiratory pressure (PEEP) set at ≥10 cmH2O for at least 12 hours,
- age 18-75 years, body weight >40 Kg,
Exclusion Criteria:
- severe air leak (more than one chest tubes per hemithorax with persistent air leak for more than 72 hours),
- systolic blood pressure lower than 90 mmHg and/or mean blood pressure lower than 65 mmHg, despite maximum support with fluids and vasopressor drugs (i.e., norepinephrine infusion rate exceeding 0.5 μg/kg/min,
- significant heart disease (e.g. ejection fraction lower than 40%, history of pulmonary edema and active ischemic disease or myocardial infarction),
- severe chronic obstructive pulmonary disease (COPD) or asthma (e.g. previous admission for COPD/asthma, chronic treatment with corticosteroids for COPD/asthma, and chronic CO2 retention more than 50 mmHg),
- intracranial pathology with intracranial pressure >20 mmHg, not responsive to maximum conservative treatment (e.g. hemorrhage, head injury, tumor, infection or acute ischemic stroke),
- chronic interstitial lung disease with bilateral lung infiltrates,
- lung biopsy or incision during the current admission,
- previous lung transplantation or bone marrow transplantation, i) pregnancy,
- immunosuppression, and
- participation in another clinical study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01478802
Contacts
| Contact: Spyros D Mentzelopoulos, A. Professor | 00306975304909 | sdmentzelopoulos@yahoo.com |
| Contact: Spyros G Zakynthinos, Professor | 00306977673885 | szakynthinos@yahoo.com |
Locations
| Greece | |
| Evaggelismos General Hospital | Recruiting |
| Athens, Attica, Greece, GR-10675 | |
| Contact: Spyros D Mentzelopoulos, A. Professor 00306975304909 sdmentzelopoulos@yahoo.com | |
| Contact: Spyros G Zakynthinos, Professor 00306977673885 szakynthinos@yahoo.com | |
| Sub-Investigator: Sotiris Malachias, MD | |
| Sub-Investigator: Klio Vrettou, MD | |
| Sub-Investigator: Sotiris Sourlas, MD | |
| Larisa University General Hospital | Recruiting |
| Larisa, Thessaly, Greece, GR-41110 | |
| Contact: Epaminondas G Zakynthinos, A. Professor 00306977217034 ezakynth@yahoo.com | |
| Contact: Dimosthenis Makris, Lecturer 6943706079 appollon7@hotmail.com | |
| Principal Investigator: Epaminondas G Zakynthinos, A. Professor | |
| Sub-Investigator: Dimosthenis Mekris, Lecturer | |
| Sub-Investigator: Constantinos Mantzarlis, MD | |
| Sub-Investigator: Apostolos Triantaris, MD | |
Sponsors and Collaborators
University of Athens
University of Thessaly
Investigators
| Principal Investigator: | Spyros D Mentzelopoulos, A. Professor | Evaggelismos Hospital, Dept. of Intensive Care Medicine, University of Athens Medical School |
| Study Chair: | Spyros G Zakynthinos, Professor | Evaggelismos Hospital, Dept. of Intensive Care Medicine, University of Athens Medical School |
| Study Chair: | Paschalis Sideras, PHD | Institute of Biomedical Research of the Athens Academy of Sciences |
More Information
Publications:
| Responsible Party: | Spyros D. Mentzelopoulos, Assistant Professor in Intensive Care Medicine, University of Athens |
| ClinicalTrials.gov Identifier: | NCT01478802 History of Changes |
| Other Study ID Numbers: | 282-13475 |
| Study First Received: | November 21, 2011 |
| Last Updated: | January 23, 2013 |
| Health Authority: | Greece: Ministry of Health and Welfare |
Keywords provided by University of Athens:
|
Mechanical Ventilation High frequency oscillation Acute Respiratory Distress syndrome |
Additional relevant MeSH terms:
|
Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Diseases Respiratory Tract Diseases |
Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Lung Injury |
ClinicalTrials.gov processed this record on May 23, 2013