Acute Respiratory Failure (ARF)NCT07286552
Breathing Pattern Description in Pneumonia Patients
An observational study of Acute Respiratory Failure (ARF), run by Consorci Sanitari Integral at 1 site in Spain.
Trial summary
Surveillance and monitoring of patients with respiratory failure before or after undergoing mechanical ventilation is an underdeveloped area compared to the many possibilities of monitoring other non-invasive vital signs that we currently have. Severe respiratory failure usually affects oxygenation and ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure (ARF)
- What is being tested?
- Temperature sensors located in the Venturi mask, placed around the nose and mouth
- Type of treatment
- Medical device
- How many people
- 82 participants
- Where
- 1 siteSpain
- Study dates
- 24 Nov 2022to 20 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients with pneumonia admitted to the Intensive Care Unit, requiring oxygen supplementation to achieve an oxygen saturation (SpO2) greater than 92%.
Who may be able to join
- Confirmed diagnosis of COVID-19 pneumonia, community-acquired or hospital-acquired with moderate, severe, or critical severity criteria as defined by the World Health Organization, OR Diagnosis of presumably bacterial pneumonia FINE III, IV or V
- Requirement for oxygen supplementation to achieve oxygen saturation (SpO2) greater than 92%
- Signed informed consent.
Who cannot join
- Non-invasive ventilation or mechanical ventilation at the time of evaluation
- Chronic noninvasive ventilation or oxygen therapy
- Inclusion in experimental treatment studies where the administered treatment is unknown
- Other more plausible cause of acute respiratory failure (ARF)
Trial locations and contacts
1 site in 1 country.
Spain1 site
Complex Hospitalari Universitari Moisès Broggi, Consorci Sanitari Integral
Sant Joan Despí, Barcelona, 08970
About this study
Official title: Noninvasive Breathing Pattern Monitoring in Patients With Acute Respiratory Failure Secondary to Pneumonia Requiring Hospital Admission: Differences Based on Clinical Outcomes
Surveillance and monitoring of patients with respiratory failure before or after undergoing mechanical ventilation is an underdeveloped area compared to the many possibilities of monitoring other non-invasive vital signs that we currently have.
Severe respiratory failure usually affects oxygenation and ventilation. Continuous or frequent non-invasive monitoring of oxygenation is performed with pulse oximetry, with a margin of error between 1 and 4% of arterial oxygen saturation of hemoglobin. Ventilation cannot be fully monitored in non-intubated patients: Measurement of respiratory rate (RR) outside the Intensive Care Unit (ICU) is usually performed intermittently and manually by the nurse, often with a wide margin of error and, regarding tidal volume (VT), it cannot currently be monitored either directly or indirectly in non-intubated patients because the measurement itself interferes with respiration. Similarly, data on inspiratory and expiratory flows cannot be obtained, which are also altered in certain pathologies. The technique considered as a "gold standard" is spirometry, which requires the collaboration of the patient, and the interpretation of the results depends on the performance of the technique in a standardized way. Spirometry offers a single value; continuous monitoring is not feasible and due to the bias of the technique.
Read more
More studies are needed to rule out the existence of different breathing patterns of acute respiratory failure and to identify outcome differences between them before recommending different support or treatment approaches.
In a preliminary not published study conducted with healthy volunteers, a good correlation was observed between changes in temperature inside the Venturi mask using two TSC50 thermistors and breathing pattern recorded by thoracic and abdominal plethysmographic bands.
HYPOTHESES: Monitoring respiratory activity, including both RR and the respiratory pattern (tidal volume, inspiratory flow, and the inspiration-to-expiration ratio), could enable early detection of respiratory patterns associated with the worsening of patients with COVID-19 pneumonia and severe pneumonia of other origins.
OBJECTIVES
Main Objective:
To evaluate the ability of the respiratory pattern to early detect respiratory deterioration in patients hospitalized pneumonia before requiring mechanical ventilation.
Specific Objectives:
To describe the initial respiratory pattern and its evolution throughout the hospital stay of patients with acute respiratory failure caused by SARS-CoV-2.
To describe the evolution of the respiratory pattern in patients with bacterial pneumonia admitted to the hospital who require supplemental oxygen.
- Conditions
- Acute Respiratory Failure (ARF)
- Being tested
- Temperature sensors located in the Venturi mask, placed around the nose and mouth
- Keywords
- Respiratory failure, coronavirus infection, bacterial pneumonia
- Medical subject headings
- Respiratory Insufficiency, Coronavirus Infections, Pneumonia, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temperature sensors located in the Venturi mask, placed around the nose and mouthDevice
Temperature sensors from the SC50 series were used, with a single use for each patient. The signals from these sensors were recorded in the supine position with the head elevated at 30º, if possible while the patient was at rest and silent. Simultaneous recordings were be made using the BIOPAC MP 160 system with general-purpose amplifiers (DA 100C).
| Study group | Role | What they receive |
|---|---|---|
| Patients with pneumonia (coronavirus or bacterial infection) admitted to the Intensive Care Unit | Study patients with pneumonia and requirement for oxygen supplementation to achieve oxygen saturation greater than 92% were followed-up, and temperature sensors were be used to register temperature changes in expired air. Clinical evolution of these patients was recorded. Receives: Device: Temperature sensors located in the Venturi mask, placed around the nose and mouth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evolution outcome
An unfavorable outcome was defined whenever the patient presented with any of the following:
- PaO2/FiO2 less than 100
- initiation of High-flow Nasal Oxygen Therapy, or invasive or noninvasive mechanical ventilation
- death Otherwise the outcome was considered as favorable.
Measured: From admission to the Intensive Care Unit until discharge or unfavorable outcome, whichever come first , assessed up to two weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start24 Nov 2022
- Primary completion28 Feb 2024
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Failure (ARF)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari Integral
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286552
- Sponsor's protocol ID
- MAR202122-30
- Status last verified
- Dec 2025
- First submitted
- 11 Aug 2025
- Last updated
- 16 Dec 2025
- 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 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Breathing Pattern Monitoring in Patients With Acute Respiratory Failure Secondary to Pneumonia Requiring Hospital Admission: Differences Based on Clinical Outcomes
- ClinicalTrials.gov ID
- NCT07286552
- Acronym / sponsor ID
- MAR202122-30
- Conditions
- Acute Respiratory Failure (ARF)
- Keywords
- Respiratory failure, coronavirus infection, bacterial pneumonia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Consorci Sanitari IntegralUniversity, hospital or other
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 16 Dec 2025 (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.
Surveillance and monitoring of patients with respiratory failure before or after undergoing mechanical ventilation is an underdeveloped area compared to the many possibilities of monitoring other non-invasive vital signs that we currently have.
Severe respiratory failure usually affects oxygenation and ventilation. Continuous or frequent non-invasive monitoring of oxygenation is performed with pulse oximetry, with a margin of error between 1 and 4% of arterial oxygen saturation of hemoglobin. Ventilation cannot be fully monitored in non-intubated patients: Measurement of respiratory rate (RR) outside the Intensive Care Unit (ICU) is usually performed intermittently and manually by the nurse, often with a wide margin of error and, regarding tidal volume (VT), it cannot currently be monitored either directly or indirectly in non-intubated patients because the measurement itself interferes with respiration. Similarly, data on inspiratory and expiratory flows cannot be obtained, which are also altered in certain pathologies. The technique considered as a "gold standard" is spirometry, which requires the collaboration of the patient, and the interpretation of the results depends on the performance of the technique in a standardized way. Spirometry offers a single value; continuous monitoring is not feasible and due to the bias of the technique.
More studies are needed to rule out the existence of different breathing patterns of acute respiratory failure and to identify outcome differences between them before recommending different support or treatment approaches.
In a preliminary not published study conducted with healthy volunteers, a good correlation was observed between changes in temperature inside the Venturi mask using two TSC50 thermistors and breathing pattern recorded by thoracic and abdominal plethysmographic bands.
HYPOTHESES: Monitoring respiratory activity, including both RR and the respiratory pattern (tidal volume, inspiratory flow, and the inspiration-to-expiration ratio), could enable early detection of respiratory patterns associated with the worsening of patients with COVID-19 pneumonia and severe pneumonia of other origins.
OBJECTIVES
Main Objective:
To evaluate the ability of the respiratory pattern to early detect respiratory deterioration in patients hospitalized pneumonia before requiring mechanical ventilation.
Specific Objectives:
To describe the initial respiratory pattern and its evolution throughout the hospital stay of patients with acute respiratory failure caused by SARS-CoV-2.
To describe the evolution of the respiratory pattern in patients with bacterial pneumonia admitted to the hospital who require supplemental oxygen.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with pneumonia (coronavirus or bacterial infection) admitted to the Intensive Care Unit | – | Device: Temperature sensors located in the Venturi mask, placed around the nose and mouthStudy patients with pneumonia and requirement for oxygen supplementation to achieve oxygen saturation greater than 92% were followed-up, and temperature sensors were be used to register temperature changes in expired air. Clinical evolution of these patients was recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pneumonia admitted to the Intensive Care Unit, requiring oxygen supplementation to achieve an oxygen saturation (SpO2) greater than 92%.
Key inclusion criteria (3 listed)
- Confirmed diagnosis of COVID-19 pneumonia, community-acquired or hospital-acquired with moderate, severe, or critical severity criteria as defined by the World Health Organization, OR Diagnosis of presumably bacterial pneumonia FINE III, IV or V
- Requirement for oxygen supplementation to achieve oxygen saturation (SpO2) greater than 92%
- Signed informed consent.
Key exclusion criteria (4 listed)
- Non-invasive ventilation or mechanical ventilation at the time of evaluation
- Chronic noninvasive ventilation or oxygen therapy
- Inclusion in experimental treatment studies where the administered treatment is unknown
- Other more plausible cause of acute respiratory failure (ARF)
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 |
|---|---|---|
| Temperature sensors located in the Venturi mask, placed around the nose and mouthTemperature sensors from the SC50 series were used, with a single use for each patient. The signals from these sensors were recorded in the supine position with the head elevated at 30º, if possible while the patient was at rest and silent. Simultaneous recordings were be made using the BIOPAC MP 160 system with general-purpose amplifiers (DA 100C). | Device | Patients with pneumonia (coronavirus or bacterial infection) admitted to the Intensive Care Unit |
Primary outcome
Clinical evolution outcome
Time frame: From admission to the Intensive Care Unit until discharge or unfavorable outcome, whichever come first , assessed up to two weeks.
An unfavorable outcome was defined whenever the patient presented with any of the following: * PaO2/FiO2 less than 100 * initiation of High-flow Nasal Oxygen Therapy, or invasive or noninvasive mechanical ventilation * death Otherwise the outcome was considered as favorable.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure (ARF), run by Consorci Sanitari Integral at 1 site in Spain.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 16 Dec 2025. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evolution outcome (time frame: From admission to the Intensive Care Unit until discharge or unfavorable outcome, whichever come first , assessed up to two weeks.). 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 16 Dec 2025.