An interventional study of 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 Obesity Hypoventilation Syndrome (OHS), Chronic Obstructive Lung Disease and Interstitial Lung Disease, sponsored by Pauls Stradins Clinical University Hospital. Recruiting at 1 site in Latvia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-19.
Sponsored by Pauls Stradins Clinical University Hospital · Not applicable, Interventional, and Diagnostic
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).
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.
73 studies on the registry are indexed under Obesity Hypoventilation Syndrome; 10 are open to participants now.
This study's planned enrollment of 30 is below the median of 40 across 42 interventional studies indexed under Obesity Hypoventilation Syndrome.
Browse Obesity Hypoventilation Syndrome studies →Pauls Stradins Clinical University Hospital is the lead sponsor of 12 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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. · 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 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.
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.
Apnea-Hypopnea Index (AHI)
The change in the Apnea-Hypopnea Index (AHI) within oxygen titration will be measured pre-interventionally and during the intervention.
Time frame: 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.
Time frame: 11 months
Blood Oxygen Saturation (SpO2)
Evaluation will include the difference in blood Oxygen Saturation (SpO2%) pre-interventionally and during the intervention.
Time frame: 11 months
Blood pressure (TA)
Evaluation will include the difference in the blood pressure (mmHg) measures pre-interventionally and during the intervention.
Time frame: 11 months
Respiratory rate (RR)
Evaluation will include the difference in the respiratory rate (xmin) measures pre-interventionally and during the intervention.
Time frame: 11 months
Heart rate (HR),
Evaluation will include the difference in the heart rate (xmin) pre-interventionally and during the intervention.
Time frame: 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.
Time frame: 11 months
adverse events description
all adverse events recorded by investigators in the CRF
Time frame: 11 months
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Obesity Hypoventilation Syndrome →
Pauls Stradins Clinical University Hospital