Telemedical Assistance in Automatic Titration of Oxygen for Intensive Care Patients
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Obesity Hypoventilation Syndrome (OHS)
- Sponsor
- Pauls Stradins Clinical University Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Respiratory rate (RR)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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).
Detailed Description
This prospective experimental study is conducted in Pauls Stradins Clinical University Hospital (PSCUH) and Sleep Disease Center in Riga, Latvia. The study includes patients with respiratory failure and hypoxemia to whom NIV is indicated. Participants clinical parameters are monitored and samples will be sent to a clinical laboratory for analysis. Initial ventilation parameters will be defined by the clinician who performs the experiment. During the validation phase, the investigators will obtain clinicians' final decision on the changes of the ventilation system parameters and compare it to our module proposal. That way it would be possible to estimate if the system is ready for the next step - fully automated closed-loop ventilation system development.
Investigators
Eligibility Criteria
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%).
Outcomes
Primary Outcomes
Respiratory rate (RR)
Time Frame: 11 months
Evaluation will include the difference in the respiratory rate (xmin) measures pre-interventionally and during the intervention.
Apnea-Hypopnea Index (AHI)
Time Frame: 11 months
The change in the Apnea-Hypopnea Index (AHI) within oxygen titration will be measured pre-interventionally and during the intervention.
Transcutaneous CO2 partial pressure (tcCO2)
Time Frame: 11 months
The change in transcutaneous CO2 partial pressure (mmHg) within oxygen titration and the time spent within an acceptable CO2-interval measured pre-interventionally and during the intervention.
Blood Oxygen Saturation (SpO2)
Time Frame: 11 months
Evaluation will include the difference in blood Oxygen Saturation (SpO2%) pre-interventionally and during the intervention.
Upper airway Carbon dioxide levels (CO2)
Time Frame: 11 months
The change in CO2 (mmHg) within oxygen titration will be measured pre-interventionally and during the intervention.
Blood pressure (TA)
Time Frame: 11 months
Evaluation will include the difference in the blood pressure (mmHg) measures pre-interventionally and during the intervention.
Heart rate (HR),
Time Frame: 11 months
Evaluation will include the difference in the heart rate (xmin) pre-interventionally and during the intervention.
Secondary Outcomes
- adverse events description(11 months)