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

NCT02027129 | Completed Phase 1

• 1 other identifier: 271-30-10-2013
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Respiratory Distress Syndrome; Acute Cor Pulmonale

Keywords

Respiratory Distress Syndrome, Adult; Cor Pulmonale; High Frequency Ventilaiton

Outcome Measures

Primary Outcomes (2)

• Right ventricular diastolic area, left ventricular diastolic area as determined by transesophageal echocardiography during the application of the tested ventilatory strategies.

  Within 6-7 hours after study enrollment

• Eccentricity index as determined by transesophageal echocardiography during the application of the tested ventilatory strategies

  Within 6-7 hours after study enrollment

Secondary Outcomes (4)

• PaO2, PaCO2 and arterial pH during the application of the tested ventilatory strategies

  Within 6-7 hours after study enrollment

• Mean arterial pressure during the application of the tested ventilatory strategies

  Within 6-7 hours after study enrollment

• Cardiac index during the application of the tested ventilatory strategies

  Within 6-7 hours after study enrollment

• Static Compliance of the Respiratory System before and after the application of the tested HFO strategies

  Within 6-7 hours after study enrollment

Other Outcomes (2)

• Occurrence of hypoxemia during the early and intermediate phase of ARDS

  Within days 1-10 after study enrollment

• Occurrence of in-hospital death and underlying cause(s)

  Within days 1-60 after study enrollment

Study Arms (1)

Low frequency HFO/HFO-TGI vs high frequency HFO

OTHER

Total study population for the testing of the ventilatory strategies

Other: High Frequency Oscillation

Interventions

High Frequency Oscillation OTHER

Comparison of low frequency HFO/HFO-TGI with cuff leak and high frequency HFO without cuff leak on right ventricular function

Low frequency HFO/HFO-TGI vs high frequency HFO

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

Evaggelismos General Hospital

Athens, Attica, 10675, Greece

Location

Related Publications (22)

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  PMID: 9449727 BACKGROUND

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  PMID: 11445688 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 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

• Mentzelopoulos SD, Malachias S, Kokkoris S, Roussos C, Zakynthinos SG. Comparison of high-frequency oscillation and tracheal gas insufflation versus standard high-frequency oscillation at two levels of tracheal pressure. Intensive Care Med. 2010 May;36(5):810-6. doi: 10.1007/s00134-010-1822-8. Epub 2010 Mar 16.

  PMID: 20232047 BACKGROUND

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  PMID: 23339638 BACKGROUND

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  PMID: 23339639 BACKGROUND

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  PMID: 22511135 BACKGROUND

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• Briel M, Meade M, Mercat A, Brower RG, Talmor D, Walter SD, Slutsky AS, Pullenayegum E, Zhou Q, Cook D, Brochard L, Richard JC, Lamontagne F, Bhatnagar N, Stewart TE, Guyatt G. Higher vs lower positive end-expiratory pressure in patients with acute lung injury and acute respiratory distress syndrome: systematic review and meta-analysis. JAMA. 2010 Mar 3;303(9):865-73. doi: 10.1001/jama.2010.218.

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  PMID: 12231488 BACKGROUND

• Mentzelopoulos SD, Anninos H, Malachias S, Zakynthinos SG. "Low-" versus "high"-frequency oscillation and right ventricular function in ARDS. A randomized crossover study. J Intensive Care. 2018 Sep 4;6:58. doi: 10.1186/s40560-018-0327-3. eCollection 2018.

  PMID: 30202530 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Pulmonary Heart Disease

Interventions

High-Frequency Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Spyros D Mentzelopoulos, MD, PhD

  University of Athens Medical School, Dept. Intensive Care Medicine

  PRINCIPAL INVESTIGATOR

• Spyros G Zakynthinos, MD, PhD

  University of Athens Medical School, Dept. Intensive Care Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Intensive Care Medicine

Study Record Dates

• First Submitted: January 2, 2014
• First Posted: January 3, 2014
• Study Start: January 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: August 17, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)