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

Primary Purpose

Obesity Hypoventilation Syndrome (OHS), Chronic Obstructive Lung Disease, Interstitial Lung Disease

Status
Recruiting
Phase
Not Applicable
Locations
Latvia
Study Type
Interventional
Intervention
PHASE 1 Lowenstein medical BiLevel Prisma 25ST device: withount oxygen support.
PHASE 2. Continous/Bilevel positive airway presure with additional oxygen support by Devilbiss 525 KS oxygen concentrator
Sponsored by
Pauls Stradins Clinical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obesity Hypoventilation Syndrome (OHS) focused on measuring Telemedicine, Smart assistant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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%).

Sites / Locations

  • Pauls Stradins Clinical Univeristy HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CPAP/APAP INTERVENTION WITH AND WITHOUT OXYGEN SUPPORT

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

adverse events description
all adverse events recorded by investigators in the CRF

Full Information

First Posted
September 11, 2023
Last Updated
October 18, 2023
Sponsor
Pauls Stradins Clinical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06090149
Brief Title
Telemedical Assistance in Automatic Titration of Oxygen for Intensive Care Patients
Acronym
Smartassistant
Official Title
Telemedical Assistance in Automatic Titration of Oxygen for Intensive Care Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pauls Stradins Clinical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity Hypoventilation Syndrome (OHS), Chronic Obstructive Lung Disease, Interstitial Lung Disease, Pneumonia
Keywords
Telemedicine, Smart assistant

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre/post study
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CPAP/APAP INTERVENTION WITH AND WITHOUT OXYGEN SUPPORT
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
PHASE 1 Lowenstein medical BiLevel Prisma 25ST device: withount oxygen support.
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
PHASE 2. Continous/Bilevel positive airway presure with additional oxygen support by Devilbiss 525 KS oxygen concentrator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Apnea-Hypopnea Index (AHI)
Description
The change in the Apnea-Hypopnea Index (AHI) within oxygen titration will be measured pre-interventionally and during the intervention.
Time Frame
11 months
Title
Transcutaneous CO2 partial pressure (tcCO2)
Description
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.
Time Frame
11 months
Title
Blood Oxygen Saturation (SpO2)
Description
Evaluation will include the difference in blood Oxygen Saturation (SpO2%) pre-interventionally and during the intervention.
Time Frame
11 months
Title
Blood pressure (TA)
Description
Evaluation will include the difference in the blood pressure (mmHg) measures pre-interventionally and during the intervention.
Time Frame
11 months
Title
Respiratory rate (RR)
Description
Evaluation will include the difference in the respiratory rate (xmin) measures pre-interventionally and during the intervention.
Time Frame
11 months
Title
Heart rate (HR),
Description
Evaluation will include the difference in the heart rate (xmin) pre-interventionally and during the intervention.
Time Frame
11 months
Title
Upper airway Carbon dioxide levels (CO2)
Description
The change in CO2 (mmHg) within oxygen titration will be measured pre-interventionally and during the intervention.
Time Frame
11 months
Secondary Outcome Measure Information:
Title
adverse events description
Description
all adverse events recorded by investigators in the CRF
Time Frame
11 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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%).
Facility Information:
Facility Name
Pauls Stradins Clinical Univeristy Hospital
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valdis Pīrags, MD, PhD
Phone
+371 29237760
Email
valdis.pirags@stradini.lv

12. IPD Sharing Statement

Learn more about this trial

Telemedical Assistance in Automatic Titration of Oxygen for Intensive Care Patients

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