Analysis of Advanced Physiological Ventilatory Parameters During Spontaneous Breathing Effort in Patients with Acute Hypoxemic Respiratory Failure

NCT ID: NCT06490523

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 31 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2022-11-30

Brief Summary

The aim of this prospective physiological cohort study conducted in a medical intensive care unit (ICU) at Hospital del Mar in Barcelona, Spain, was to analyze the proportion of time spent within the "safe" range of respiratory effort (including esophageal pressure swing (ΔPes), respiratory muscular pressure (Pmus), and transdiaphragmatic pressure swing (ΔPdi)) in patients with acute hypoxemic respiratory failure (AHRF) undergoing invasive mechanical ventilation (IMV), during the active breathing phase in relation to ICU survival.

The investigators hypothesized that AHRF patients on IMV with better outcome (i.e., ICU survivors) spend more time within the "safe" range of respiratory effort during the active breathing phase compared to non-survivors.

AHRF patients on IMV were continuously monitored with esophageal and gastric manometry from the detection of the onset of respiratory effort for up to 7 days, or until extubation, or until death, whichever occurred first.

Detailed Description

To characterize in detail the evolution of respiratory effort over time, the investigators conducted a prospective observational cohort study with continuous recordings of airway pressure, flow, esophageal and gastric pressures for up to 7 days after the onset of respiratory effort in AHRF patients on IMV.

Patients were classified into two groups: ICU survivors and ICU non-survivors. The primary objective of the study was to analyze the proportion of time spent within a specified "safe" range for Pmus, ΔPes, and ΔPdi (respiratory effort physiological variables), during spontaneous breathing, comparing both groups during the first 7 days after the initiation of respiratory effort. The secondary objective was to analyze the median values of ΔPes, Pmus, and ΔPdi during the monitorization period (active breathing phase) between the two groups.

Conditions

Acute Hypoxic Respiratory Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ICU survivors

Acute hypoxemic respiratory failure patients on invasive mechanical ventilation who survive to ICU discharge

No interventions assigned to this group

ICU non-survivors

Acute hypoxemic respiratory failure patients on invasive mechanical ventilation who do not survive to ICU discharge

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Acute hypoxemic respiratory failure patients requiring invasive mechanical ventialtion

Exclusion Criteria

• Presence of chest drains
• Contraindication to esophageal catheterization (e.g., recent upper gastrointestinal surgery, bleeding esophageal varices)
• Concomitant acute exacerbation of obstructive airways disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital del Mar Research Institute (IMIM)

OTHER

Sponsor Role: lead

Responsible Party

Andrea Castellvi

Clinical Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital del Mar

Barcelona, Catalonia, Spain

Countries

Spain

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Other Identifiers

2021/9742

Identifier Type: -

Identifier Source: org_study_id