Respiratory Distress Syndrome Clinical Trial
— EFFORT-1Official title:
The Association Between Respiratory Effort Parameters During the First 48 Hours With Clinical Outcomes in Mechanically Ventilated Patients: A Prospective Observational Study.
Verified date | May 2024 |
Source | Ramathibodi Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Over-assisted mechanical ventilation (MV) is linked to respiratory muscle disuse atrophy, while under-assisted MV can lead to patient self-inflicted lung injury (P-SILI) or respiratory muscle injuries. Both scenarios result in poor outcomes. This hypothesis aims to demonstrate the association between the degree of respiratory effort which was measured by P0.1, predicted Pmus, and predicted Δtranspulmonary pressure (ΔPL) with ventilator-free days (VFD) and 28-day mortality.
Status | Completed |
Enrollment | 163 |
Est. completion date | April 30, 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Participants must be aged between 18-75 years. 2. Admitted to the critical care and semi-critical care units (ICUs) of the Department of -Internal Medicine, Ramathibodi Hospital (ICUs 9IC, 8IK, and 7NW). 3. Patients with acute respiratory failure admitted to the hospital with the following conditions within the first 48 hours: - PaO2/FiO2 greater than 150 or - PaO2 less than 60 mm Hg or - SaO2 less than 90 mm Hg or - Work of breathing more than 25 breaths per minute or requiring respiratory muscle assistance 4. Permission obtained from the attending physician. 5. Research participants or their direct relatives must sign informed consent. 6. The research can commence and data can be recorded within 48 hours after the patient has received treatment with the mechanical ventilator. Exclusion Criteria: 1. Admitted to the hospital or had a history of hospital admission within a month before recruitment. 2. History of cardiovascular or cerebrovascular events within the last 12 months. 3. Pregnant. 4. Terminal-stage cancer patient, terminal illness-stage of disease who desire palliative care. 5. Active neurological or muscular disorders affecting stability. 6. Brain coma, brain death, or status epilepticus. 7. Severe mental health conditions, including active depression with psychotic features, bipolar disorder, or schizophrenia. 8. Uncontrolled thyroid conditions within a month before recruitment. 9. Uncorrectable patients with severe hypoxemia (P/F ratio less than 150). 10. Patients receiving neuromuscular blocking agents. |
Country | Name | City | State |
---|---|---|---|
Thailand | Mr. Phruet Soipetkasem | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Ramathibodi Hospital |
Thailand,
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 28 days ventilator-free days (VFDs) | The number of VFDs was defined as the number of days from the last day of mechanical ventilation to day 28. If a patient died during the first 28 days, their number of VFDs is equal to zero. | After intubated patients were recruited until successful extubation or dead/failed extubation with in 28 days. | |
Secondary | 28 days all-cause mortality | Short-term mortality was defined as death occurring within 28 days from the start of enrollment, documented as either alive or deceased 28 days after intubation. | After intubated patients were recruited until alive or dead with in 28 days. |
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