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

NCT03513809 | Unknown

• 2 other identifiers: 1703150071171810
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Hypoxemic Respiratory Failure; Acute Respiratory Distress Syndrome

Keywords

Acute Hypoxemic Respiratory Failure; Acute Respiratory Distress Syndrome; Electrical impedance tomography; Spontaneous breathing; Ventilation induced-lung injury; Patient self-inflicted lung injury

Outcome Measures

Primary Outcomes (1)

• Inflammation

  Cytokine analysis (TNF-α, IL-1β, IL-6, IL-8 and IL-10) in serum, bronchoalveolar lavage fluid (BALF) and tissue supernatants.

  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).

Secondary Outcomes (1)

• Pulmonary ventilation distribution

  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.

Study Arms (1)

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

Interventions

Thoracic electrical impedance tomography DEVICE

Non invasive, radiation-free, bedside monitoring tool for distribution of pulmonary ventilation.

Acute hypoxemic respiratory failure

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• Comisión Nacional de Investigación Científica y Tecnológica: collaborator

Study Sites (1)

Hospital Clínico Universidad Católica

Santiago, Chile

RECRUITING

Related Publications (4)

• Brochard L. Ventilation-induced lung injury exists in spontaneously breathing patients with acute respiratory failure: Yes. Intensive Care Med. 2017 Feb;43(2):250-252. doi: 10.1007/s00134-016-4645-4. Epub 2017 Jan 10. No abstract available.

  PMID: 28074228 RESULT

• Mascheroni D, Kolobow T, Fumagalli R, Moretti MP, Chen V, Buckhold D. Acute respiratory failure following pharmacologically induced hyperventilation: an experimental animal study. Intensive Care Med. 1988;15(1):8-14. doi: 10.1007/BF00255628.

  PMID: 3230208 RESULT

• Yoshida T, Uchiyama A, Fujino Y. The role of spontaneous effort during mechanical ventilation: normal lung versus injured lung. J Intensive Care. 2015 Jun 17;3:18. doi: 10.1186/s40560-015-0083-6. eCollection 2015.

  PMID: 27408729 RESULT

• Yoshida T, Fujino Y, Amato MB, Kavanagh BP. Fifty Years of Research in ARDS. Spontaneous Breathing during Mechanical Ventilation. Risks, Mechanisms, and Management. Am J Respir Crit Care Med. 2017 Apr 15;195(8):985-992. doi: 10.1164/rccm.201604-0748CP.

  PMID: 27786562 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples and bronchoalveolar lavage samples.

MeSH Terms

Conditions

Respiratory Insufficiency; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Lung Diseases

Study Officials

• Jaime A Retamal

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaime A Retamal

CONTACT

56942611087; jaimeretamal@gmail.com

María C Bachmann

CONTACT

56973838527; mcbachmann@uc.cl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 2, 2018
• Study Start: June 8, 2017
• Primary Completion: March 21, 2021
• Study Completion: March 31, 2021
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)