Telemedical Assistance in Automatic Titration of Oxygen for Intensive Care Patients

Pneumonia Clinical Trial

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Official title:

Telemedical Assistance in Automatic Titration of Oxygen for Intensive Care Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06090149
• Other study ID #: E1.1.1.1/21/A/082
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: October 2023
• Source: Pauls Stradins Clinical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%).

Related Conditions & MeSH terms

• Chronic Obstructive Lung Disease
• Hypoventilation
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Lung Diseases, Obstructive
• Obesity Hypoventilation Syndrome
• Obesity Hypoventilation Syndrome (OHS)
• Pneumonia
• Pulmonary Disease, Chronic Obstructive

Intervention

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.
• 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.

Locations

Country	Name	City	State
Latvia	Pauls Stradins Clinical Univeristy Hospital	Riga

Sponsors (1)

Lead Sponsor	Collaborator
Pauls Stradins Clinical University Hospital

Country where clinical trial is conducted

Latvia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Blood Oxygen Saturation (SpO2)	Evaluation will include the difference in blood Oxygen Saturation (SpO2%) pre-interventionally and during the intervention.	11 months
Primary	Blood pressure (TA)	Evaluation will include the difference in the blood pressure (mmHg) measures pre-interventionally and during the intervention.	11 months
Primary	Respiratory rate (RR)	Evaluation will include the difference in the respiratory rate (xmin) measures pre-interventionally and during the intervention.	11 months
Primary	Heart rate (HR),	Evaluation will include the difference in the heart rate (xmin) pre-interventionally and during the intervention.	11 months
Primary	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	adverse events description	all adverse events recorded by investigators in the CRF	11 months