Telemedical Assistance in Automatic Titration of Oxygen for Intensive Care Patients

Not Applicable

Recruiting

• Conditions: Pneumonia; Obesity Hypoventilation Syndrome (OHS); Chronic Obstructive Lung Disease; Interstitial Lung Disease
• Interventions: Device: PHASE 2. Continous/Bilevel positive airway presure with additional oxygen support by Devilbiss 525 KS oxygen concentrator

• Registration Number: NCT06090149
• Lead Sponsor: Pauls Stradins Clinical University Hospital

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.

Study Timeline

• Study Start: 2023-03-01
• Study First Submitted: 2023-09-11
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-18
• Last Update Submitted: 2023-10-18
• Study First Posted: 2023-10-19
• Last Update Posted: 2023-10-19
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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%).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CPAP/APAP INTERVENTION WITH AND WITHOUT OXYGEN SUPPORT	PHASE 2. Continous/Bilevel positive airway presure with additional oxygen support by Devilbiss 525 KS oxygen concentrator	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.

Primary Outcome Measures

Name	Time	Method
Respiratory rate (RR)	11 months	Evaluation will include the difference in the respiratory rate (xmin) measures pre-interventionally and during the intervention.
Apnea-Hypopnea Index (AHI)	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)	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)	11 months	Evaluation will include the difference in blood Oxygen Saturation (SpO2%) pre-interventionally and during the intervention.
Upper airway Carbon dioxide levels (CO2)	11 months	The change in CO2 (mmHg) within oxygen titration will be measured pre-interventionally and during the intervention.
Blood pressure (TA)	11 months	Evaluation will include the difference in the blood pressure (mmHg) measures pre-interventionally and during the intervention.
Heart rate (HR),	11 months	Evaluation will include the difference in the heart rate (xmin) pre-interventionally and during the intervention.

Secondary Outcome Measures

Name	Time	Method
adverse events description	11 months	all adverse events recorded by investigators in the CRF

Trial Locations

Locations (1)

Pauls Stradins Clinical Univeristy Hospital; 🇱🇻 Riga, Latvia