Obesity Hypoventilation Syndrome (OHS)SmartassistantNCT06090149
Telemedical Assistance in Automatic Titration of Oxygen for Intensive Care Patients
A study testing PHASE 1 Lowenstein medical BiLevel Prisma 25ST device: withount oxygen support. and PHASE 2. Continous/Bilevel positive airway presure with additional oxygen support by Devilbiss 525 KS oxygen concentrator in people with Obesity Hypoventilation Syndrome (OHS) and Chronic Obstructive Lung Disease, run by Pauls Stradins Clinical University Hospital at 1 site in Latvia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity Hypoventilation Syndrome (OHS), Chronic Obstructive Lung Disease, Interstitial Lung Disease
- What is being tested?
- PHASE 1 Lowenstein medical BiLevel Prisma 25ST device: withount oxygen support. and PHASE 2. Continous/Bilevel positive airway presure with additional oxygen support by Devilbiss 525 KS oxygen concentrator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteLatvia
- Study dates
- 1 Mar 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Latvia1 site, 1 recruiting
- Recruiting
Pauls Stradins Clinical Univeristy Hospital
Riga, LV-1002
Valdis Pīrags, MD, PhD, +371 29237760, valdis.pirags@stradini.lv
About this study
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).
Read the 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.
- Conditions
- Obesity Hypoventilation Syndrome (OHS), Chronic Obstructive Lung Disease, Interstitial Lung Disease, Pneumonia
- Being tested
- 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
- Keywords
- Telemedicine, Smart assistant
- Medical subject headings
- Obesity Hypoventilation Syndrome, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHASE 1 Lowenstein medical BiLevel Prisma 25ST device: withount oxygen support.Device
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 concentratorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CPAP/APAP INTERVENTION WITH AND WITHOUT OXYGEN SUPPORT | Experimental | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea Index (AHI)
The change in the Apnea-Hypopnea Index (AHI) within oxygen titration will be measured pre-interventionally and during the intervention.
Measured: 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.
Measured: 11 months
Blood Oxygen Saturation (SpO2)
Evaluation will include the difference in blood Oxygen Saturation (SpO2%) pre-interventionally and during the intervention.
Measured: 11 months
Blood pressure (TA)
Evaluation will include the difference in the blood pressure (mmHg) measures pre-interventionally and during the intervention.
Measured: 11 months
Respiratory rate (RR)
Evaluation will include the difference in the respiratory rate (xmin) measures pre-interventionally and during the intervention.
Measured: 11 months
Heart rate (HR),
Evaluation will include the difference in the heart rate (xmin) pre-interventionally and during the intervention.
Measured: 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.
Measured: 11 months
Secondary outcomes (1)
adverse events description
all adverse events recorded by investigators in the CRF
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Mar 2023
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity Hypoventilation Syndrome (OHS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre/post study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pauls Stradins Clinical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090149
- Sponsor's protocol ID
- E1.1.1.1/21/A/082
- Acronym
- Smartassistant
- Status last verified
- Oct 2023
- First submitted
- 11 Sep 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedical Assistance in Automatic Titration of Oxygen for Intensive Care Patients
- ClinicalTrials.gov ID
- NCT06090149
- Acronym / sponsor ID
- Smartassistant / E1.1.1.1/21/A/082
- Conditions
- Obesity Hypoventilation Syndrome (OHS), Chronic Obstructive Lung Disease, Interstitial Lung Disease, Pneumonia
- Keywords
- Telemedicine, Smart assistant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Pauls Stradins Clinical University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre/post study
| Arm | Type | Receives |
|---|---|---|
| CPAP/APAP INTERVENTION WITH AND WITHOUT OXYGEN SUPPORT | Experimental | 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 concentratorPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | CPAP/APAP INTERVENTION WITH AND WITHOUT OXYGEN SUPPORT |
| PHASE 2. Continous/Bilevel positive airway presure with additional oxygen support by Devilbiss 525 KS oxygen concentratorThe 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. | Device | CPAP/APAP INTERVENTION WITH AND WITHOUT OXYGEN SUPPORT |
Primary outcome
Apnea-Hypopnea Index (AHI)
Time frame: 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)
Time frame: 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)
Time frame: 11 months
Evaluation will include the difference in blood Oxygen Saturation (SpO2%) pre-interventionally and during the intervention.
Blood pressure (TA)
Time frame: 11 months
Evaluation will include the difference in the blood pressure (mmHg) measures pre-interventionally and during the intervention.
Respiratory rate (RR)
Time frame: 11 months
Evaluation will include the difference in the respiratory rate (xmin) measures pre-interventionally and during the intervention.
Heart rate (HR),
Time frame: 11 months
Evaluation will include the difference in the heart rate (xmin) pre-interventionally and during the intervention.
Upper airway Carbon dioxide levels (CO2)
Time frame: 11 months
The change in CO2 (mmHg) within oxygen titration will be measured pre-interventionally and during the intervention.
1 secondary outcome
adverse events description
Time frame: 11 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
Related trials for Obesity Hypoventilation Syndrome (OHS)
Not yet recruiting
Hypercapnic Burden in Adults With Obesity Undergoing Diagnostic Polysomnography for Suspected Obstructive Sleep Apnea
Obstructive Sleep Apnea, Obesity (BMI>30)
RecruitingObservational study
The Use of Entropy to Assess Sleep Disordered Breathing in Chronic Respiratory Disease
Bronchial Asthma, Bronchiectasis
Not yet recruiting
The Effect of Mask Design on Ventilation Parameters in COPD and OHS Patients on Long-term Home Non-invasive Ventilation. An Experimental Study.
COPD (Chronic Obstructive Pulmonary Disease), Obesity Hypoventilation Syndrome (OHS)
Recruiting
Assessment of Breathing Pattern During NIV
COPD (Chronic Obstructive Pulmonary Disease), Obesity Hypoventilation Syndrome (OHS)
Not yet recruitingObservational study
Evaluation of Upper Extremity Functions in Obesity Hypoventilation Syndrome Patients
Obesity Hypoventilation Syndrome (OHS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PHASE 1 Lowenstein medical BiLevel Prisma 25ST device: withount oxygen support. and PHASE 2. Continous/Bilevel positive airway presure with additional oxygen support by Devilbiss 525 KS oxygen concentrator in people with Obesity Hypoventilation Syndrome (OHS) and Chronic Obstructive Lung Disease, run by Pauls Stradins Clinical University Hospital at 1 site in Latvia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Latvia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-Hypopnea Index (AHI) (time frame: 11 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.