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

NCT00416260 | Completed Phase 1 DMC

• 1 other identifier: 10532-HFO-TGI
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Distress Syndrome, Adult

Keywords

Respiratory Distress Syndrome, Adult; High-Frequency Ventilation; Respiration, Artificial

Outcome Measures

Primary Outcomes (2)

• Physiological variables (i.e. ventilation pressures and oxygenation) during the first 7-10 days following randomization

  8-10 days post-randomization

• Survival to days 28 and 60 post-randomization and to Hospital Discharge

  28 days to more than 60 days post-randomization

Secondary Outcomes (3)

• Ventilator free days

  28 days and 60 days

• Number of Organ or system failure free days

  28 days and 60 days

• Occurence of Barotraumas/airway injury

  28 days and 60 days

Study Arms (2)

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

CMV

NO INTERVENTION

Patients with severe Acute Respiratory Distress Syndrome receiving only conventional mechanical ventilation according to the study protocol

Interventions

High Frequency Oscillation and Tracheal Gas Insufflation OTHER

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.

HFO-TGI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

Evaggelismos General Hospital

Athens, Attica, GR-106 75, Greece

Location

Related Publications (14)

• 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. doi: 10.1378/chest.126.2.518.

  PMID: 15302739 BACKGROUND

• 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. doi: 10.1097/01.ccm.0000155785.23200.9e.

  PMID: 15753735 BACKGROUND

• 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. doi: 10.1164/rccm.2108052.

  PMID: 12231488 BACKGROUND

• Imai Y, Slutsky AS. High-frequency oscillatory ventilation and ventilator-induced lung injury. Crit Care Med. 2005 Mar;33(3 Suppl):S129-34. doi: 10.1097/01.ccm.0000156793.05936.81.

  PMID: 15753718 BACKGROUND

• Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.

  PMID: 10793162 BACKGROUND

• Pillow JJ. High-frequency oscillatory ventilation: mechanisms of gas exchange and lung mechanics. Crit Care Med. 2005 Mar;33(3 Suppl):S135-41. doi: 10.1097/01.ccm.0000155789.52984.b7.

  PMID: 15753719 BACKGROUND

• 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. doi: 10.1164/ajrccm/146.6.1411.

  PMID: 1456557 BACKGROUND

• 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. doi: 10.1164/ajrccm/148.3.562.

  PMID: 8368624 BACKGROUND

• 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 (1985). 1993 Sep;75(3):1238-46. doi: 10.1152/jappl.1993.75.3.1238.

  PMID: 8226536 BACKGROUND

• 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. doi: 10.1097/01.CCM.0000265738.80832.BE.

  PMID: 17440419 BACKGROUND

• 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. doi: 10.1164/ajrccm.149.3.7509706.

  PMID: 7509706 BACKGROUND

• 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. doi: 10.1097/00003246-200201000-00021. No abstract available.

  PMID: 11902255 BACKGROUND

• 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. doi: 10.1007/s00134-005-2838-3. Epub 2005 Oct 26.

  PMID: 16249926 BACKGROUND

• Mentzelopoulos SD, Malachias S, Zintzaras E, Kokkoris S, Zakynthinos E, Makris D, Magira E, Markaki V, Roussos C, Zakynthinos SG. Intermittent recruitment with high-frequency oscillation/tracheal gas insufflation in acute respiratory distress syndrome. Eur Respir J. 2012 Mar;39(3):635-47. doi: 10.1183/09031936.00158810. Epub 2011 Sep 1.

  PMID: 21885390 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Respiratory Aspiration

Interventions

High-Frequency Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Charis Roussos, Professor

  First Department of Intensive Care Medicine, University of Athens Medical School

  STUDY CHAIR

• Spyros G Zakynthinos, As Professor

  First Department of Intensive Care Medicine, University of Athens Medical School

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Intensive Care Medicine

Study Record Dates

• First Submitted: December 26, 2006
• First Posted: December 27, 2006
• Study Start: July 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: June 24, 2014

Record last verified: 2014-06

Locations

GR (1)