Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2026-01-15 @ 6:26 AM
Study NCT ID:
NCT04241861
Status:
COMPLETED
Last Update Posted:
2021-02-08
First Post:
2020-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-flow Nasal Cannula vs. Helmet PSV vs. Helmet CPAP During Respiratory Failure
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Study Overview
Official Title:
Physiological Comparison of High-flow Nasal Cannula, Helmet Pressure Support Ventilation and Continuous Positive Airway Pressure During Acute Hypoxemic Respiratory Failure: a Randomized Cross-over Study
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HIGHFLOWHELMET
Brief Summary:
The investigators designed a cross-over, randomized trial to assess the physiological effects of helmet pressure support ventilation (PSV) and continuous positive airway pressure (CPAP) as compared to high-flow nasal cannula during the early phase of acute hypoxemic respiratory failure
Detailed Description:
Setting: 21-bed general ICU, emergency room of the Emergency department (ED), Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS, Rome, Italy..
Patients: adult hypoxemic non-hypercapnic patients admitted to the emergency department or the ICU with de novo acute respiratory failure will be assessed for the enrolment.
Each eligible patient, in the absence of exclusion criteria, will receive 15 minutes of heated and humidified 60% oxygen at a rate of 50 l/min via a non-rebreathing face mask. An ABG will be then collected and PaO2/FiO2 ratio computed: given the high flows used, actual FiO2 will be approximated to the set one.
Nonhypercapnic patients with a PaO2/FiO2≤200 mmHg will be enrolled. In the absence of exclusion criteria and if all other inclusion in criteria are met, patients showing PaO2/FiO2≤300 and \>200 mmHg will be treated according to the clinical practice eventually reassessed for the presence of oxygenation criterion subsequently.
Enrolled patients will receive all the interventions (helmet CPAP, PSV and high-flow nasal cannula) in a randomized, cross-over fashion, for 40 minutes each.
At the end of the study, the patient will receive the treatment that will be shown as more appropriate for the patient, according to the attending physician, who will be informed about the results of the study on the individual patient.
Patients: adult hypoxemic non-hypercapnic patients admitted to the emergency department or the ICU with de novo acute respiratory failure will be assessed for the enrolment.
Each eligible patient, in the absence of exclusion criteria, will receive 15 minutes of heated and humidified 60% oxygen at a rate of 50 l/min via a non-rebreathing face mask. An ABG will be then collected and PaO2/FiO2 ratio computed: given the high flows used, actual FiO2 will be approximated to the set one.
Nonhypercapnic patients with a PaO2/FiO2≤200 mmHg will be enrolled. In the absence of exclusion criteria and if all other inclusion in criteria are met, patients showing PaO2/FiO2≤300 and \>200 mmHg will be treated according to the clinical practice eventually reassessed for the presence of oxygenation criterion subsequently.
Enrolled patients will receive all the interventions (helmet CPAP, PSV and high-flow nasal cannula) in a randomized, cross-over fashion, for 40 minutes each.
At the end of the study, the patient will receive the treatment that will be shown as more appropriate for the patient, according to the attending physician, who will be informed about the results of the study on the individual patient.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: