Inflammation and Distribution of Pulmonary Ventilation Before and After Tracheal Intubation in ARDS Patients
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|ClinicalTrials.gov Identifier: NCT03513809|
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : August 30, 2019
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
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||40 participants|
|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|
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.
- 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.
- 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
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): NCT03513809
|Contact: Jaime A Retamalfirstname.lastname@example.org|
|Contact: María C Bachmannemail@example.com|
|Hospital Clínico Universidad Católica||Recruiting|
|Contact: Jaime A Retamal 56 9 4261 1087 firstname.lastname@example.org|
|Contact: María C Bachmann 56973838527 email@example.com|
|Principal Investigator:||Jaime A Retamal||Pontificia Universidad Catolica de Chile|