Trial record 2 of 8 for:    Open Studies | "Pulmonary Heart Disease"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Athens
Sponsor:
Information provided by (Responsible Party):
Spyros D. Mentzelopoulos, University of Athens
ClinicalTrials.gov Identifier:
NCT02027129
First received: January 2, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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 ] [ Designated as safety issue: Yes ]
  • Eccentricity index as determined by transesophageal echocardiography during the application of the tested ventilatory strategies [ Time Frame: Within 6-7 hours after study enrollment ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
  • Mean arterial pressure during the application of the tested ventilatory strategies [ Time Frame: Within 6-7 hours after study enrollment ] [ Designated as safety issue: No ]
  • Cardiac index during the application of the tested ventilatory strategies [ Time Frame: Within 6-7 hours after study enrollment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 16
Study Start Date: January 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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: NCT02027129

Contacts
Contact: Spyros D Mentzelopoulos, MD, PhD, Ass. Professor +306975304909 sdmentzelopoulos@yahoo.com
Contact: Spyros G Zakynthinos, MD, PhD, Professor +306977673885 szakynthinos@yahoo.com

Locations
Greece
Evaggelismos General Hospital Recruiting
Athens, Attica, Greece, 10675
Contact: Spyros D Mentzelopoulos, MD, PhD    +306975304909    sdmentzelopoulos@yahoo.com   
Contact: Spyros G Zakynthinos, MD, PhD    +306977673885    szakynthinos@yahoo.com   
Sub-Investigator: Ector Aninos, MD         
Sub-Investigator: Sotirios Malachias, MD, PhD         
Sub-Investigator: Charikleia Vrettou, MD         
Sub-Investigator: Anastasios Stathopoulos, MD         
Sub-Investigator: Marios Karvouniaris, MD         
Sub-Investigator: Maria Theodoridi, MD         
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
Study First Received: January 2, 2014
Last Updated: January 2, 2014
Health Authority: Greece: Ethics Committee

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

Additional relevant MeSH terms:
Pulmonary Heart Disease
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
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014