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Study of a Novel Technique of Mechanical Ventilation in Patients With Severe Acute Respiratory Failure (HFO-TGI-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00637507
Recruitment Status : Completed
First Posted : March 18, 2008
Last Update Posted : November 21, 2016
University of Thessaly
Information provided by (Responsible Party):
Spyros D. Mentzelopoulos, University of Athens

Brief Summary:
The investigators have recently demonstrated the beneficial effects of combined high-frequency oscillation (HFO) and tracheal gas insufflation (TGI) on the respiratory physiology [1,2] of patients with severe acute respiratory distress syndrome (ARDS) (NCT00416260). Preliminary short-term survival results were also encouraging. Consequently, in the present clinical trial, the investigators intend to increase the size of the studied population, in order to evaluate the effect of HFO-TGI on survival with adequate statistical power. Furthermore, the investigators intend to elucidate the mechanism of the HFO-TGI-related physiological benefit.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome Other: High-frequency Oscillation and Tracheal Gas Insufflation Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II/Phase III Study of the Effect of Combined High-frequency Oscillation and Tracheal Gas Insufflation on the Survival to Hospital Discharge of Patients With Severe Acute Respiratory Distress Syndrome
Study Start Date : March 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Arm Intervention/treatment
No Intervention: 2
Patients treated solely with a pressure- and volume-limited ventilatory strategy (target plateau pressure of 30 cm H2O) aimed at minimizing lung stress and strain, and thus, ventilator-induced lung injury.
Experimental: 1
Intermittent application of High-frequency Oscillation (HFO) and Tracheal Gas Insufflation (TGI) according to pre-specified criteria described in the Detailed Description. HFO-TGI sessions are interspersed with lung protective conventional mechanical ventilation until the PaO2/FiO2 ratio stabilizes at >150 mm Hg.
Other: High-frequency Oscillation and Tracheal Gas Insufflation
Patients will receive daily sessions of High-frequency Oscillation and Tracheal Gas Insufflation (HFO-TGI), which will last at least 6 hours. These sessions will comprise a recruitment period of at least 90 min, a stabilization period of at least 4 hours, and a weaning period of at least 60 min. The HFO-TGI strategy will be aimed at initially maximizing PaO2/FiO2 without causing hemodynamic compromise (e.g., >10% reduction in cardiac output/index), and subsequently maintaining PaO2/FiO2 >150 mm Hg, while gradually reducing mPaw to 4-6 cm H2O below its initial setting. The weaning from TGI and HFO will be according to the reversal of the oxygenation criterion that mandated their use (see also Detailed Description).
Other Name: HFO-TGI

Primary Outcome Measures :
  1. Survival to days 28 and 60 post-randomization, and to Hospital Discharge [ Time Frame: 28 days to more than 60 days post-randomization ]

Secondary Outcome Measures :
  1. Lung recruitment during the study-intervention period [ Time Frame: 8 days post-randomization ]
  2. Evolution of Gas-exchange, Hemodynamics, and Respiratory Mechanics during the Study Intervention Period [ Time Frame: 8-10 days post-randomization ]
  3. Ventilator Free Days [ Time Frame: 60 days post-randomization ]
  4. Organ or System Failure Free Days [ Time Frame: 60 days post-randomization ]
  5. Occurrence of barotrauma (i.e., any new pneumothorax, pneumomediastinum, or subcutaneous emphysema, or pneumatocele > 2 cm) [ Time Frame: 60 days post-randomization ]
  6. Occurence of Tracheal Mucosal Injury due to use of Tracheal Gas Insufflation [ Time Frame: 8-10 days post-randomization ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18-75 years
  • Body weight > 40 kg
  • Endotracheal intubation and mechanical ventilation
  • Diagnosis of ARDS established within preceding 72 h
  • Severe oxygenation disturbances: PaO2/FiO2 <150 mm Hg sustained for 12 h, despite being ventilated with PEEP ≥8 cm H2O

Exclusion Criteria:

  • Active air leak or recent severe air leak (severe air leak: > 1 chest tube per hemithorax with persistent gas leak for > 72 h)
  • Severe hemodynamic instability (i.e., systolic arterial pressure < 90 mm Hg despite volume loading and norepinephrine infusion at ≥ 0.5 μg/kg/min)
  • Significant heart disease (i.e., ejection fraction <40 %, and/or history of pulmonary edema, and/or active coronary ischemia or myocardial infarction)
  • Significant chronic obstructive pulmonary disease (COPD) or asthma {i.e., previous admissions for COPD/asthma, chronic corticosteroid therapy for COPD/asthma, and documented chronic CO2 retention leading to a baseline PaCO2 of > 50 mm Hg (for COPD)}
  • Uncontrollable intracranial hypertension (i.e., intracranial pressure >20 mm Hg despite deep sedation, analgesia, hyperosmolar therapy, and minute ventilation titrated to PaCO2 = 35 mm Hg)
  • Chronic Interstitial Lung Disease associated with bilateral pulmonary infiltrates
  • Lung biopsy or resection on current admission
  • Immunosuppression caused by

    • neutropenia [i.e., polymorphonuclear leukocyte count < 1,000/μL (1 x 1012/L)] after chemotherapy or bone marrow transplantation for hematologic cancers
    • corticosteroid or cytotoxic therapy for a nonmalignant disease
    • the acquired immunodeficiency syndrome
  • Inability to wean from prone positioning or inhaled nitric oxide
  • Pregnancy or morbid obesity (body mass index >40 kg/m2)
  • Enrollment in another interventional study
  • Crossover from the CMV-group to the HFO-TGI-group at > 72 h after the onset of the severe oxygenation disturbances

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00637507

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Department of Intensive Care Medicine, Evaggelismos Hospital
Athens, Attica, Greece, GR-10675
University General Hospital of Larissa
Larissa, Thessaly, Greece, GR-41110
Sponsors and Collaborators
University of Athens
University of Thessaly
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Principal Investigator: Spyros D Mentzelopoulos, MD, PhD University of Athens Medical School, Athens, Greece
Principal Investigator: Sotiris Malachias, MD Department of Intensive Care Medicine, Evaggelismos Hospital, Athens, Greece
Study Director: Spyros G Zakynthinos, MD, PhD University of Athens Medical School, Athens, Greece
Study Chair: Charis Roussos, MD, PhD University of Athens Medical School, Athens, Greece

Publications of Results:
Mentzelopoulos SD, Malachias S, Tzoufi M, Markaki V, Zervakis D, Pitaridis M, Zakynthinos S. High frequency oscillation and tracheal gas insufflation for severe acute respiratory distress syndrome [abstract]. Intensive Care Med 2007;33(Suppl 2):S142

Other Publications:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Spyros D. Mentzelopoulos, Assistant Professor of Intensive Care Medicine, University of Athens Identifier: NCT00637507     History of Changes
Other Study ID Numbers: HFO-TGI-728-4-10-07
First Posted: March 18, 2008    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: November 2016
Keywords provided by Spyros D. Mentzelopoulos, University of Athens:
High-Frequency Ventilation
Tracheal Gas Insufflation
Respiration, Artificial
Respiratory Distress Syndrome
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases