Telemedical Assistance in Automatic Titration of Oxygen for Intensive Care Patients (Smartassistant)

Pauls Stradins Clinical University Hospital

Status: Enrolling

Conditions: Chronic Obstructive Lung Disease; Obesity Hypoventilation Syndrome (OHS); Pneumonia; Interstitial Lung Disease

Treatments: Device: PHASE 2. Continous/Bilevel positive airway presure with additional oxygen support by Devilbiss 525 KS oxygen concentrator; Device: PHASE 1 Lowenstein medical BiLevel Prisma 25ST device: withount oxygen support.

Study type: Interventional

Funder types: Other

Identifiers

NCT06090149

E1.1.1.1/21/A/082

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

CPAP/APAP INTERVENTION WITH AND WITHOUT OXYGEN SUPPORT

Experimental group

Description:

Patients in this group will be selected from the Sleep Disorder Center database for printing data on hypoxemia below 90% during the night and for treatment received (CPAP/APAP and/or oxygen therapy). And from available data in PSCUH data systems on patient diagnoses, previous results of studies (results of blood gas tests), and recommended treatments on hospital and outpatient disease cards, which will include indications of possible chronic hypoxemia. The selected patients will be called (telephone visit) and, if agreed, will be scheduled for study time. Consequently, if the consent questionnaire was signed, a study will be launched following an evaluation of the inclusion and exclusion criteria.

Treatment:

Device: PHASE 1 Lowenstein medical BiLevel Prisma 25ST device: withount oxygen support.

Device: PHASE 2. Continous/Bilevel positive airway presure with additional oxygen support by Devilbiss 525 KS oxygen concentrator