Combined High Frequency Oscillation and Tracheal Gas Insufflation for Severe Acute Respiratory Distress Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Spyros D. Mentzelopoulos, University of Athens
ClinicalTrials.gov Identifier:
NCT00416260
First received: December 26, 2006
Last updated: June 21, 2014
Last verified: June 2014
  Purpose

In the past five years, there is a growing body of published evidence on the feasibility, and oxygenation and lung protection benefits of high frequency oscillation (HFO) in the acute respiratory distress syndrome (ARDS). The investigators have recently demonstrated the short term feasibility and additional benefits with respect to oxygenation of HFO combined with tracheal gas insufflation (TGI). In the present clinical trial, the investigators intend to test the hypothesis that HFO-TGI may result in improved respiratory physiology and clinical course compared to low tidal volume conventional mechanical ventilation in patients with severe ARDS.


Condition Intervention Phase
Respiratory Distress Syndrome, Adult
Other: High Frequency Oscillation and Tracheal Gas Insufflation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1/Phase 2, Single-Center, Controlled Study of the Effectiveness of Combined High Frequency Oscillation and Tracheal Gas Insufflation in Improving the Clinical Course of Patients With Severe Acute Respiratory Distress Syndrome

Resource links provided by NLM:


Further study details as provided by University of Athens:

Primary Outcome Measures:
  • Physiological variables (i.e. ventilation pressures and oxygenation) during the first 7-10 days following randomization [ Time Frame: 8-10 days post-randomization ] [ Designated as safety issue: No ]
  • Survival to days 28 and 60 post-randomization and to Hospital Discharge [ Time Frame: 28 days to more than 60 days post-randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ventilator free days [ Time Frame: 28 days and 60 days ] [ Designated as safety issue: No ]
  • Number of Organ or system failure free days [ Time Frame: 28 days and 60 days ] [ Designated as safety issue: No ]
  • Occurence of Barotraumas/airway injury [ Time Frame: 28 days and 60 days ] [ Designated as safety issue: Yes ]

Enrollment: 54
Study Start Date: July 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HFO-TGI
Patients with severe Acute Respiratory Distress Syndrome receiving sessions of high frequency oscillation and tracheal gas insufflation according to the study protocol
Other: High Frequency Oscillation and Tracheal Gas Insufflation
Intermittent combined use of High Frequency Oscillation and Tracheal Gas Insufflation until the PaO2/inspired oxygen fraction ratio remains above than 150 mm Hg for more than 24 hours.
No Intervention: CMV
Patients with severe Acute Respiratory Distress Syndrome receiving only conventional mechanical ventilation according to the study protocol

  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 Acute Respiratory Distress Syndrome
  • PaO2/FiO2 < 150 mm Hg at PEEP ≥ 8 cm H2O
  • Age 18-75 years
  • Body weight > 40 kg

Exclusion Criteria:

  • More than 1 chest tube/hemithorax with persistent airleak for > 72 h)
  • Systolic pressure < 90 mm Hg with fluids/norepinephrine at ≥ 0.5 μg/kg/min
  • Heart disease (defined in Detailed Description)
  • Chronic obstructive pulmonary disease (defined in Detailed Description)
  • Intracranial abnormalities (any cause of intracranial pressure > 20 mm Hg)
  • Chronic interstitial lung disease
  • Lung biopsy or resection on current admission
  • Previous lung or bone marrow transplant or immunosuppression
  • Pregnancy or morbid obesity
  • Inability to wean from prone positioning or inhaled nitric oxide
  • Enrollment in another interventional study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416260

Locations
Greece
Evaggelismos General Hospital
Athens, Attica, Greece, GR-106 75
Sponsors and Collaborators
University of Athens
Investigators
Principal Investigator: Spyros D Mentzelopoulos, Lecturer First Department of Intensive Care Medicine, University of Athens Medical School
Principal Investigator: Sotiris M Malachias, Consultant First Department of Intensive Care Medicine, University of Athens Medical School
Study Chair: Charis Roussos, Professor First Department of Intensive Care Medicine, University of Athens Medical School
Study Director: Spyros G Zakynthinos, As Professor First Department of Intensive Care Medicine, University of Athens Medical School
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Spyros D. Mentzelopoulos, Assistant Professor of Intensive Care Medicine, University of Athens
ClinicalTrials.gov Identifier: NCT00416260     History of Changes
Other Study ID Numbers: 10532-HFO-TGI
Study First Received: December 26, 2006
Last Updated: June 21, 2014
Health Authority: Greece: Ministry of Health and Welfare

Keywords provided by University of Athens:
Respiratory Distress Syndrome, Adult
High-Frequency Ventilation
Respiration, Artificial

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014