Status:
TERMINATED
RENOVATE Palliative: HFNC vs. Standard Respiratory Support in Patients With Do-Not-Intubate Order and ARF
Lead Sponsor:
Hospital do Coracao
Collaborating Sponsors:
Ministry of Health, Brazil
Fisher and Paykel Healthcare
Conditions:
Care, Palliative
Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Randomized clinical trial in which the main objective is to compare High Flow Nasal Cannula (HFNC) versus the standard respiratory care in the alleviation of dyspnea perception in patients with do-not...
Detailed Description
Do-not-intubate (DNI) is usually established in cases where endotracheal intubation (ETI) is considered disproportionate to prognosis and/or incompatible with the expression of wishes and values of th...
Eligibility Criteria
Inclusion
- Participants must be 18 years of age or older, with ARF of any cause on admission or post-extubation with prior DNI directives or DNI order determined in the current hospitalization.
- Patients must meet the following criteria below:
- Dyspnea (defined on the Borg scale ≥4);
- SpO2 \<90% or paO2 \<60 mmHg in room air;
- Absence of delirium;
- One of the following:
- A. Signs of respiratory distress and use of accessory muscles; B. Respiratory rate greater than 25 incursions per min .
Exclusion
- Refusal of treatment;
- Agitation or non-cooperation;
- Presence of delirium at the time of randomization;
- Anatomical abnormalities that may interfere with the adjustment of the non-invasive positive pressure ventilation mask
- Glasgow \<12;
- Psychomotor agitation that prevents adequate medical / nursing assistance requiring sedation;
- Contraindications to NIV: uncontrollable vomiting, hypersecretion of the airways, facial deformities, trauma or extensive facial burn;
- Presence of pneumothorax or extensive pleural effusion;
- Expected imminent death, defined as an estimated death of less than 24 hours.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2021
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04269681
Start Date
December 1 2020
End Date
August 9 2021
Last Update
August 16 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Nereu Ramos
Florianópolis, Santa Catarina, Brazil