Chronic Obstructive Lung Disease, Interstitial Lung Disease, Obesity Hypoventilation Syndrome (OHS), Pneumonia
Conditions
Keywords
Telemedicine, Smart assistant
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.
Interventions
DEVICEPHASE 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.
DEVICEPHASE 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.
Sponsors
Pauls Stradins Clinical University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Pre/post study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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%).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Upper airway Carbon dioxide levels (CO2) | 11 months | The change in CO2 (mmHg) within oxygen titration will be measured pre-interventionally and during the intervention. |
| Apnea-Hypopnea Index (AHI) | 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) | 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) | 11 months | Evaluation will include the difference in blood Oxygen Saturation (SpO2%) pre-interventionally and during the intervention. |
| Blood pressure (TA) | 11 months | Evaluation will include the difference in the blood pressure (mmHg) measures pre-interventionally and during the intervention. |
| Respiratory rate (RR) | 11 months | Evaluation will include the difference in the respiratory rate (xmin) measures pre-interventionally and during the intervention. |
| Heart rate (HR), | 11 months | Evaluation will include the difference in the heart rate (xmin) pre-interventionally and during the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse events description | 11 months | all adverse events recorded by investigators in the CRF |
Countries
Latvia
Outcome results
None listed