Combined High Frequency Oscillation and Tracheal Gas Insufflation for Severe Acute Respiratory Distress Syndrome - Full Text View

Sponsor:	University of Athens
Information provided by:	University of Athens
ClinicalTrials.gov Identifier:	NCT00416260

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 I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Gas

U.S. FDA Resources

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
HFO-TGI: Experimental 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.
CMV: No Intervention 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

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

Locations

Greece, Attica
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:

Mehta S, Granton J, MacDonald RJ, Bowman D, Matte-Martyn A, Bachman T, Smith T, Stewart TE. High-frequency oscillatory ventilation in adults: the Toronto experience. Chest. 2004 Aug;126(2):518-27.

Ferguson ND, Chiche JD, Kacmarek RM, Hallett DC, Mehta S, Findlay GP, Granton JT, Slutsky AS, Stewart TE. Combining high-frequency oscillatory ventilation and recruitment maneuvers in adults with early acute respiratory distress syndrome: the Treatment with Oscillation and an Open Lung Strategy (TOOLS) Trial pilot study. Crit Care Med. 2005 Mar;33(3):479-86.

Derdak S, Mehta S, Stewart TE, Smith T, Rogers M, Buchman TG, Carlin B, Lowson S, Granton J; Multicenter Oscillatory Ventilation For Acute Respiratory Distress Syndrome Trial (MOAT) Study Investigators. High-frequency oscillatory ventilation for acute respiratory distress syndrome in adults: a randomized, controlled trial. Am J Respir Crit Care Med. 2002 Sep 15;166(6):801-8.

Imai Y, Slutsky AS. High-frequency oscillatory ventilation and ventilator-induced lung injury. Crit Care Med. 2005 Mar;33(3 Suppl):S129-34. Review.

[No authors listed] Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. The Acute Respiratory Distress Syndrome Network. N Engl J Med. 2000 May 4;342(18):1301-8.

Pillow JJ. High-frequency oscillatory ventilation: mechanisms of gas exchange and lung mechanics. Crit Care Med. 2005 Mar;33(3 Suppl):S135-41. Review.

Nahum A, Ravenscraft SA, Nakos G, Burke WC, Adams AB, Marcy TW, Marini JJ. Tracheal gas insufflation during pressure-control ventilation. Effect of catheter position, diameter, and flow rate. Am Rev Respir Dis. 1992 Dec;146(6):1411-8.

Burke WC, Nahum A, Ravenscraft SA, Nakos G, Adams AB, Marcy TW, Marini JJ. Modes of tracheal gas insufflation. Comparison of continuous and phase-specific gas injection in normal dogs. Am Rev Respir Dis. 1993 Sep;148(3):562-8.

Nahum A, Ravenscraft SA, Nakos G, Adams AB, Burke WC, Marini JJ. Effect of catheter flow direction on CO2 removal during tracheal gas insufflation in dogs. J Appl Physiol. 1993 Sep;75(3):1238-46.

Mentzelopoulos SD, Roussos C, Koutsoukou A, Sourlas S, Malachias S, Lachana A, Zakynthinos SG. Acute effects of combined high-frequency oscillation and tracheal gas insufflation in severe acute respiratory distress syndrome. Crit Care Med. 2007 Jun;35(6):1500-8.

Bernard GR, Artigas A, Brigham KL, Carlet J, Falke K, Hudson L, Lamy M, Legall JR, Morris A, Spragg R. The American-European Consensus Conference on ARDS. Definitions, mechanisms, relevant outcomes, and clinical trial coordination. Am J Respir Crit Care Med. 1994 Mar;149(3 Pt 1):818-24. Review.

Murray MJ, Cowen J, DeBlock H, Erstad B, Gray AW Jr, Tescher AN, McGee WT, Prielipp RC, Susla G, Jacobi J, Nasraway SA Jr, Lumb PD; Task Force of the American College of Critical Care Medicine (ACCM) of the Society of Critical Care Medicine (SCCM), American Society of Health-System Pharmacists, American College of Chest Physicians. Clinical practice guidelines for sustained neuromuscular blockade in the adult critically ill patient. Crit Care Med. 2002 Jan;30(1):142-56. No abstract available.

Mentzelopoulos SD, Roussos C, Zakynthinos SG. Static pressure volume curves and body posture in acute respiratory failure. Intensive Care Med. 2005 Dec;31(12):1683-92. Epub 2005 Oct 26.

Responsible Party:	University of Athens ( Spyros D Mentzelopoulos, MD, PhD, Lecturer in Intensive Care Medicine )
Study ID Numbers:	10532-HFO-TGI
Study First Received:	December 26, 2006
Last Updated:	February 23, 2009
ClinicalTrials.gov Identifier:	NCT00416260 History of Changes
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:

Pathologic Processes
Disease
Respiratory Tract Diseases
Lung Diseases

Syndrome
Respiration Disorders
Respiratory Distress Syndrome, Adult

ClinicalTrials.gov processed this record on November 22, 2009