NCT07286552

Breathing Pattern Description in Pneumonia Patients

Active, enrolled Last updated 16 December 2025

What this trial tests

trial testing Temperature sensors located in the Venturi mask, placed around the nose and mouth in Acute Respiratory Failure (ARF) in 82 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

24 November 2022

Primary endpoint
28 February 2024

20 December 2025

Quick facts

Lead sponsor	Consorci Sanitari Integral
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	82
Start date	24 November 2022
Primary completion	28 February 2024
Estimated completion	20 December 2025
Sites	1 location across Spain

Drugs / interventions tested

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

Conditions studied

• Acute Respiratory Failure (ARF) — all drugs for Acute Respiratory Failure (ARF) →

Sponsor

Consorci Sanitari Integral — full company profile →

Who can join

18 and older, any sex, with Acute Respiratory Failure (ARF). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.