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New treatment option for Respiratory Insufficiency
Official title Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout
ClinicalTrials.gov ID: NCT06483984
What this study is testing
- What it's testing
- The objective of this randomized cross-over trial is to assess the physiological effects of three different facemasks for noninvasive ventilation (Nivairo, Visairo, Optiniv) in patients with acute hypercapnic respiratory failure
- 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 respiratory failure with
- PaCO2 ≥ 45 mmHg;
- Arterial pH \< 7.35;
- Signed written informed consent
You likely can't join if
- Respiratory rate \< 12 bpm;
- Immediate need for intubation;
- Haemodynamic instability (Systolic blood pressure \ 5 mmol/L) and/or clinically diagnosed shock;
- Metabolic Acidosis;
- Recent head surgery or anatomy that prevent the application of facemasks;
- Any contraindications to oesophageal balloon insertion and/or electrical impedance tomography (EIT) belt placement.
See the full eligibility criteria
- Acute respiratory failure with
- PaCO2 ≥ 45 mmHg;
- Arterial pH \< 7.35;
- Signed written informed consent
- Respiratory rate \< 12 bpm;
- Immediate need for intubation;
- Haemodynamic instability (Systolic blood pressure \ 5 mmol/L) and/or clinically diagnosed shock;
- Metabolic Acidosis;
- Recent head surgery or anatomy that prevent the application of facemasks;
- Any contraindications to oesophageal balloon insertion and/or electrical impedance tomography (EIT) belt placement.
- Any contraindications to facemask noninvasive ventilation.
The study team makes the final eligibility decision.
Where it's taking place
- Roma, Italy
- Rome, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 Roma, Italy; 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.