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Physiological Study of Low-frequency HFO/HFO-TGI and High-frequency HFO

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02027129
First Posted: January 3, 2014
Last Update Posted: August 17, 2017
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.
Information provided by (Responsible Party):
Spyros D. Mentzelopoulos, University of Athens
  Purpose
Recent data from large trials of high-frequency high frequency oscillation (HFO) without a cuff leak vs, lung-protective conventional ventialtion (CMV) failed to show any HFO-related benefit with respect to outcome. A possible explanation is that HFO increases the probability of right ventricular dysfunction due to the combination of high mean airway pressures (mPaws) and hypercapnia. In contrast, available preliminary data on low-frequency HFO-tracheal gas insufflation (TGI) with cuff leak vs. CMV are suggestive of an HFO-TGI related benefit. Low-frequency HFO-TGI with a cuff leak is associated with relatively low mean tracheal pressures and adequate control of PaCO2. Thus, the investigators intend to test the hypothesis that low frequency HFO +/- TGI with a cuff leak is associated with better right ventricular function relative to high-frequency HFO without a cuff leak.

Condition Intervention Phase
Acute Respiratory Distress Syndrome Acute Cor Pulmonale Other: High Frequency Oscillation Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Cardio-respiratory Variables Between Low-frequency High Frequency Oscillation With/Without Tracheal Gas Insufflation and High-frequency High-frequency Oscillation in Severe ARDS.

Resource links provided by NLM:


Further study details as provided by Spyros D. Mentzelopoulos, University of Athens:

Primary Outcome Measures:
  • Right ventricular diastolic area, left ventricular diastolic area as determined by transesophageal echocardiography during the application of the tested ventilatory strategies. [ Time Frame: Within 6-7 hours after study enrollment ]
  • Eccentricity index as determined by transesophageal echocardiography during the application of the tested ventilatory strategies [ Time Frame: Within 6-7 hours after study enrollment ]

Secondary Outcome Measures:
  • PaO2, PaCO2 and arterial pH during the application of the tested ventilatory strategies [ Time Frame: Within 6-7 hours after study enrollment ]
  • Mean arterial pressure during the application of the tested ventilatory strategies [ Time Frame: Within 6-7 hours after study enrollment ]
  • Cardiac index during the application of the tested ventilatory strategies [ Time Frame: Within 6-7 hours after study enrollment ]
  • Static Compliance of the Respiratory System before and after the application of the tested HFO strategies [ Time Frame: Within 6-7 hours after study enrollment ]

Other Outcome Measures:
  • Occurrence of hypoxemia during the early and intermediate phase of ARDS [ Time Frame: Within days 1-10 after study enrollment ]
  • Occurrence of in-hospital death and underlying cause(s) [ Time Frame: Within days 1-60 after study enrollment ]

Enrollment: 17
Study Start Date: January 2014
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Low frequency HFO/HFO-TGI vs high frequency HFO
Total study population for the testing of the ventilatory strategies
Other: High Frequency Oscillation
Comparison of low frequency HFO/HFO-TGI with cuff leak and high frequency HFO without cuff leak on right ventricular function

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

Acute Respiratory Distress Syndrome (ARDS) according to the Berlin Definition Onset of ARDS within the 72 hours preceding study enrollment PaO2/FiO2 of less than 150 mmHg while ventilated with a positive end-expiratory pressure of at least 10 cmH2O Body weight of more than 40 Kg Age 18-75 years

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, despite maximum support with fluids and vasopressor drugs Significant heart disease Severe chronic obstructive pulmonary disease or asthma Intracranial hypertension Chronic interstitial lung disease with bilateral lung infiltrates Lung biopsy or incision during the current admission Previous lung transplantation or bone marrow transplantation Pregnancy

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02027129


Locations
Greece
Evaggelismos General Hospital
Athens, Attica, Greece, 10675
Sponsors and Collaborators
University of Athens
Investigators
Principal Investigator: Spyros D Mentzelopoulos, MD, PhD University of Athens Medical School, Dept. Intensive Care Medicine
Study Chair: Spyros G Zakynthinos, MD, PhD University of Athens Medical School, Dept. Intensive Care Medicine
  More Information

Publications:

Responsible Party: Spyros D. Mentzelopoulos, Assistant Professor in Intensive Care Medicine, University of Athens
ClinicalTrials.gov Identifier: NCT02027129     History of Changes
Other Study ID Numbers: 271-30-10-2013
First Submitted: January 2, 2014
First Posted: January 3, 2014
Last Update Posted: August 17, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Spyros D. Mentzelopoulos, University of Athens:
Respiratory Distress Syndrome, Adult
Cor Pulmonale
High Frequency Ventilaiton

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