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Inflammation and Distribution of Pulmonary Ventilation Before and After Tracheal Intubation in ARDS Patients

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03513809
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : August 30, 2019
Comisión Nacional de Investigación Científica y Tecnológica
Information provided by (Responsible Party):
Jaime Retamal, Pontificia Universidad Catolica de Chile

Brief Summary:

Spontaneous breathing efforts in patients with respiratory failure connected to mechanical ventilation, has been associated with strong respiratory muscles activity. However, these mechanisms may will be present in patients with acute lung deseases who are breathing with no ventilatory support.

We hypothesize that spontaneous breathing during acute respiratory failure could induced lung inflammation and worsen lung damage. Hereby, the connection to a ventilatory support tool, may protect the lungs from spontaneous ventilation-induced lung injury.

To test our hypothesis, our aim is to determine the effects of spontaneous breathing in acute respiratory failure patients, on lung injury distribution; and to determine whether early controlled mechanical ventilation can avoid these deleterious effects by improving air distribution.

Condition or disease Intervention/treatment
Acute Hypoxemic Respiratory Failure Acute Respiratory Distress Syndrome Device: Thoracic electrical impedance tomography

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Days
Official Title: Spontaneous Breathing and Progression of Lung Injury in Acute Respiratory Distress Syndrome Before Connection to Mechanical Ventilation
Actual Study Start Date : June 8, 2017
Estimated Primary Completion Date : June 8, 2021
Estimated Study Completion Date : June 8, 2021

Group/Cohort Intervention/treatment
Acute hypoxemic respiratory failure
Patients with acute hypoxemic respiratory failure breathing spontaneously with no requirements of immediate intubation connected to thoracic electrical impedance tomography.
Device: Thoracic electrical impedance tomography
Non invasive, radiation-free, bedside monitoring tool for distribution of pulmonary ventilation.

Primary Outcome Measures :
  1. Inflammation [ Time Frame: Plasma: At the time of enrollment and 48 hours post intubation. BALF: Immediately post intubation and 48-96 hours post intubation (only if it is required and indicated by the attending physician). ]
    Cytokine analysis (TNF-α, IL-1β, IL-6, IL-8 and IL-10) in serum, bronchoalveolar lavage fluid (BALF) and tissue supernatants.

Secondary Outcome Measures :
  1. Pulmonary ventilation distribution [ Time Frame: Every 6 hours from enrollment to intubation and after connection to mechanical ventilation each hour for the first 6 hours and then at 12, 18, 24 and 48 hours. ]
    Regional pulmonary ventilation distribution at bedside with electrical impedance tomography

Biospecimen Retention:   Samples Without DNA
Plasma samples and bronchoalveolar lavage samples.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to the ICU of the Hospital Clínico UC-Christus, Santiago de Chile, with diagnosis of acute hypoxemic respiratory failure, but who are still ventilating spontaneously.

Inclusion Criteria:

  • Acute respiratory symptoms for less than seven days
  • Acute hypoxemic respiratory failure defined by a ratio of partial pressure of arterial oxygen (Pao2) to Fio2 of 300 mm Hg or less, while breathing with standard oxygen mask at FiO2 > or equal to 30%
  • Increased work of breathing defined by either:

    i. Respiratory rate > 25 / min, or ii. Signs of intercostal or supraclavicular retraction

  • Less than 24 hours since criteria 2 and 3 are met.

Exclusion Criteria:

  • Acute respiratory failure secondary to exacerbation of chronic respiratory disease or to cardiogenic pulmonary edema, PaCO2 > 45 mm Hg, decreased conscious level (Glasgow Coma Scale < 13), urgent need for endotracheal intubation, a decision not to resuscitate, and consent refusal.

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 identifier (NCT number): NCT03513809

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Contact: Jaime A Retamal 56942611087
Contact: María C Bachmann 56973838527

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Hospital Clínico Universidad Católica Recruiting
Santiago, Chile
Contact: Jaime A Retamal    56 9 4261 1087   
Contact: María C Bachmann    56973838527   
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Comisión Nacional de Investigación Científica y Tecnológica
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Principal Investigator: Jaime A Retamal Pontificia Universidad Catolica de Chile

Additional Information:

Publications of Results:
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Responsible Party: Jaime Retamal, Medical Doctor, Pontificia Universidad Catolica de Chile Identifier: NCT03513809     History of Changes
Other Study ID Numbers: 170315007
1171810 ( Other Grant/Funding Number: FONDECYT )
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There isn't plan for IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jaime Retamal, Pontificia Universidad Catolica de Chile:
Acute Hypoxemic Respiratory Failure
Acute Respiratory Distress Syndrome
Electrical impedance tomography
Spontaneous breathing
Ventilation induced-lung injury
Patient self-inflicted lung injury
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Respiratory Tract Diseases
Infant, Newborn, Diseases
Acute Lung Injury
Lung Injury
Pathologic Processes
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Thoracic Injuries
Wounds and Injuries