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

• Register: ClinicalTrials.gov
• Last refreshed on: 22 March 2021
• Main ID: NCT03513809
• Date of registration: 19/04/2018
• Prospective Registration: No
• Primary sponsor: Pontificia Universidad Catolica de Chile
• Public title: Inflammation and Distribution of Pulmonary Ventilation Before and After Tracheal Intubation in ARDS Patients
• Scientific title: Spontaneous Breathing and Progression of Lung Injury in Acute Respiratory Distress Syndrome Before Connection to Mechanical Ventilation
• Date of first enrolment: June 8, 2017
• Target sample size: 40
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03513809
• Study type: Observational [Patient Registry]

Countries of recruitment

Chile

Contacts

• Name: Jaime A Retamal

• Name: Jaime A Retamal

• Name: Jaime A Retamal
• Affiliation: Pontificia Universidad Catolica de Chile

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Acute Respiratory Distress Syndrome

Acute Hypoxemic Respiratory Failure

Intervention(s)

Device: Thoracic electrical impedance tomography

Primary Outcome(s)

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).]

Secondary Outcome(s)

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.]

Secondary ID(s)

1171810

170315007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Comisión Nacional de Investigación Científica y Tecnológica