BridgeMD
New treatment option for Respiratory Failure
Official title Helmet NIV vs. CPAP vs. High-flow Nasal Oxygen in Hypoxemic Respiratory Failure
ClinicalTrials.gov ID: NCT05089695
What this study is testing
- What it's testing
- Multicenter, open label, three-arm randomized trial to assess the effect of helmet noninvasive ventilation vs. helmet continuous positive airway pressure vs.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Acute symptoms of respiratory failure PaO2/FiO2 ratio ≤ 200; PaCO2≤45mmHg; Absence of history of chronic respiratory failure or moderate to severe...
- Patients that have already received NIV, CPAP continuously for more than 24 hours before the screening visit will be excluded.
- Other
You likely can't join if
- Pregnancy;
- Exacerbation of asthma or chronic obstructive pulmonary disease;
- Hypercapnia (PaCO2\>45 mmHg) with or without respiratory acidosis;
- More than 2 organ failures, including the lung.
- Documented pneumothorax;
- Clinical diagnosis of Cardiogenic pulmonary edema;
See the full eligibility criteria
- Acute symptoms of respiratory failure PaO2/FiO2 ratio ≤ 200; PaCO2≤45mmHg; Absence of history of chronic respiratory failure or moderate to severe cardiac insufficiency (NYHA\>2 or left ventricular ejection...
- Patients that have already received NIV, CPAP continuously for more than 24 hours before the screening visit will be excluded.
- Other
- Pregnancy;
- Exacerbation of asthma or chronic obstructive pulmonary disease;
- Hypercapnia (PaCO2\>45 mmHg) with or without respiratory acidosis;
- More than 2 organ failures, including the lung.
- Documented pneumothorax;
- Clinical diagnosis of Cardiogenic pulmonary edema;
- Haemodynamic instability (Systolic blood pressure\ 5 mmol/L) and/or clinically diagnosed Shock requiring administration of vasoactive agents (norepinephrine\>0.1 mcg/Kg/min);
- Metabolic Acidosis (pH \<7.30 with normal- or hypo-carbia);
- Chronic kidney failure requiring dialysis before ICU admission;
- Chronic hypoxemic respiratory failure requiring long-term oxygen therapy;
- Altered neurological status that requires immediate intubation and/or making the patient uncooperative;
- Urgent need for endotracheal intubation, according to the decision of the attending physician;
- Do not intubate order;
- Decision of withdrawal of life-sustaining therapy;
- Thoracic or abdominal surgery in the previous 7 days;
- Any condition that makes the patient very likely to require endotracheal intubation due to a reason different from respiratory failure;
- Recent head surgery or anatomy that prevent the application of helmet or HFNC to patient's face.
The study team makes the final eligibility decision.
Where it's taking place
- Rome, Italy
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rome, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.