Telemedical Assistance in Automatic Titration of Oxygen for Intensive Care Patients (NCT06090149) | Clinical Trial Compass
UnknownNot Applicable
Telemedical Assistance in Automatic Titration of Oxygen for Intensive Care Patients
Latvia30 participantsStarted 2023-03-01
Plain-language summary
The goal of this clinical trial is to clinically validate a system for the monitoring of patients' respiratory function and automated oxygen treatment proposal using non-invasive ventilation devices in the treatment of intensive care patients with acute or chronic lung diseases exacerbations. Participants clinical parameters will be monitored and samples will be sent to a clinical laboratory for analysis (arterial blood pressure, heart rate, and respiratory rate will be continuously recorded, and FeO2 and CO2 will be measured with the help of an additional sensor).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* signed informed consent to participate in the study;
* aged over 18 years;
* patients hospitalized with acute respiratory failure (indication to NIV therapy) with restrictive or obstructive lung disease
Exclusion Criteria:
* refusal to participate further in the study;
* age under 18 years;
* pregnancy;
* the patient is contraindicated for non-invasive lung ventilation
* during the study, the patients condition worsens in such a way that an active one is required medical intervention or continuation of the study may worsen the patients condition;
* complications related to NIV therapy or claustrophobia;
* chronic obstructive pulmonary disease and obstructive sleep apnea without documented hypoxemia (Sp02 and Sa02 \> 94%).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Apnea-Hypopnea Index (AHI)
Timeframe: 11 months
2
Transcutaneous CO2 partial pressure (tcCO2)
Timeframe: 11 months
3
Blood Oxygen Saturation (SpO2)
Timeframe: 11 months
4
Blood pressure (TA)
Timeframe: 11 months
5
Respiratory rate (RR)
Timeframe: 11 months
6
Heart rate (HR),
Timeframe: 11 months
7
Upper airway Carbon dioxide levels (CO2)
Timeframe: 11 months
Trial details
NCT IDNCT06090149
SponsorPauls Stradins Clinical University Hospital