Clinical trial NCT06090149: Telemedical Assistance in Automatic Titration of Oxygen for Intensive Care Patients
Official title: Telemedical Assistance in Automatic Titration of Oxygen for Intensive Care Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity Hypoventilation Syndrome (OHS)
Chronic Obstructive Lung Disease
Interstitial Lung Disease
Pneumonia
Keywords: Telemedicine
Smart assistant
Lead sponsor: Pauls Stradins Clinical University Hospital
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre/post study
Primary purpose: DIAGNOSTIC

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.

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%).

Primary outcomes:
measure: Apnea-Hypopnea Index (AHI)
timeFrame: 11 months
measure: Transcutaneous CO2 partial pressure (tcCO2)
timeFrame: 11 months
measure: Blood Oxygen Saturation (SpO2)
timeFrame: 11 months
measure: Blood pressure (TA)
timeFrame: 11 months
measure: Respiratory rate (RR)
timeFrame: 11 months
measure: Heart rate (HR),
timeFrame: 11 months
measure: Upper airway Carbon dioxide levels (CO2)
timeFrame: 11 months
Secondary outcomes:
measure: adverse events description
timeFrame: 11 months
Other outcomes:
Locations:
city: Riga
country: Latvia
facility: Pauls Stradins Clinical Univeristy Hospital
Study officials:
References: