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

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).

Study Overview

• Status: Recruiting
• Conditions: Pneumonia; Interstitial Lung Disease; Chronic Obstructive Lung Disease; Obesity Hypoventilation Syndrome (OHS)
• Intervention / 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

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Latvia
  • Riga, Latvia, LV-1002
    • Recruiting
    • Pauls Stradins Clinical Univeristy Hospital
    • Contact: Valdis Pīrags, MD, PhD; Phone Number: +371 29237760; Email: valdis.pirags@stradini.lv

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CPAP/APAP INTERVENTION WITH AND WITHOUT OXYGEN SUPPORT; 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.

Device: PHASE 1 Lowenstein medical BiLevel Prisma 25ST device: withount oxygen support.; The patient will be invited to enter the study's first phase using the Lowenstein medical BiLevel Prisma 25ST device without additional oxygen support. The study will be conducted within 1-3 days. If patients fail to achieve proper blood oxygen saturation without oxygen supplementation, patient will be selected to proceed to the next step - oxygen-enriched positive airway pressure intervention During monitoring TA, RR, HR, SpO2, as well as CO2 in both exhales/inhales and transcutaneous positions will be measured by Lowenstein Medical Sonata and Sentec device.; Device: PHASE 2. Continous/Bilevel positive airway presure with additional oxygen support by Devilbiss 525 KS oxygen concentrator; The patient will be invited to enter the third phase of the study with rapid oxygen titration. Titration occurs in an inpatient department where the patient is connected to the Lowenstein medical BiLevel Prisma 25ST device with oxygen support during the daytime. As part of the study, the patient will be supplied with oxygen by Devilbiss 525 KS oxygen concentrator at a dosing interval of 1-10 L/min. Every 2 hours oxygen support will be increased by 2L/min. During monitoring TA, RR, HR, SpO2, and CO2 in both exhales/inhales and transcutaneous positions will be measured by Lowenstein Medical Sonata and Sentec device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea-Hypopnea Index (AHI)	The change in the Apnea-Hypopnea Index (AHI) within oxygen titration will be measured pre-interventionally and during the intervention.	11 months
Transcutaneous CO2 partial pressure (tcCO2)	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.	11 months
Blood Oxygen Saturation (SpO2)	Evaluation will include the difference in blood Oxygen Saturation (SpO2%) pre-interventionally and during the intervention.	11 months
Blood pressure (TA)	Evaluation will include the difference in the blood pressure (mmHg) measures pre-interventionally and during the intervention.	11 months
Respiratory rate (RR)	Evaluation will include the difference in the respiratory rate (xmin) measures pre-interventionally and during the intervention.	11 months
Heart rate (HR),	Evaluation will include the difference in the heart rate (xmin) pre-interventionally and during the intervention.	11 months
Upper airway Carbon dioxide levels (CO2)	The change in CO2 (mmHg) within oxygen titration will be measured pre-interventionally and during the intervention.	11 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse events description	all adverse events recorded by investigators in the CRF	11 months

Collaborators and Investigators

• Sponsor: Pauls Stradins Clinical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): November 30, 2023
• Study Completion (Estimated): November 30, 2023

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Telemedicine; Smart assistant
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease Attributes; Overnutrition; Nutrition Disorders; Overweight; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Respiratory Insufficiency; Obesity; Sleep Apnea, Obstructive; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial; Hypoventilation; Obesity Hypoventilation Syndrome
• Other Study ID Numbers: E1.1.1.1/21/A/082

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No