Breathing Pattern Description in Pneumonia Patients

NCT07286552 | Active Not Recruiting

• 1 other identifier: MAR202122-30
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acute Respiratory Failure (ARF)

Keywords

Respiratory failure; coronavirus infection; bacterial pneumonia

Outcome Measures

Primary Outcomes (1)

• 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.

  From admission to the Intensive Care Unit until discharge or unfavorable outcome, whichever come first , assessed up to two weeks.

Study Arms (1)

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.

Device: Temperature sensors located in the Venturi mask, placed around the nose and mouth

Interventions

Temperature sensors located in the Venturi mask, placed around the nose and mouth DEVICE

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).

Patients with pneumonia (coronavirus or bacterial infection) admitted to the Intensive Care Unit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pneumonia admitted to the Intensive Care Unit, requiring oxygen supplementation to achieve an oxygen saturation (SpO2) greater than 92%.

You may qualify if:

• 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.

You may not qualify if:

• Non-invasive ventilation or mechanical ventilation at the time of evaluation
• Chronic noninvasive ventilation or oxygen therapy
• Other more plausible cause of acute respiratory failure (ARF)

Sponsors & Collaborators

• Consorci Sanitari Integral: lead

Study Sites (1)

Complex Hospitalari Universitari Moisès Broggi, Consorci Sanitari Integral

Sant Joan Despí, Barcelona, 08970, Spain

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Coronavirus Infections; Pneumonia, Bacterial

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Pneumonia; Respiratory Tract Infections; Lung Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: December 16, 2025
• Study Start: November 24, 2022
• Primary Completion: February 28, 2024
• Study Completion: December 20, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

ES (1)