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

November 18, 2024 updated by: Andrea Castellvi, Hospital del Mar Research Institute (IMIM)

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Catalunya
      • Barcelona, Catalunya, Spain, 08003
        • Hospital del Mar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients aged 18 years or older who were admitted to the ICU and required invasive mechanical ventilation (IMV) for acute hypoxemic respiratory failure (AHRF) were eligible for the study. Patients were excluded if they had chest drains, a contraindication to esophageal catheterization (e.g., recent upper gastrointestinal surgery, bleeding esophageal varices), or a concomitant acute exacerbation of obstructive airways disease.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ICU survivors
Acute hypoxemic respiratory failure patients on invasive mechanical ventilation who survive to ICU discharge
ICU non-survivors
Acute hypoxemic respiratory failure patients on invasive mechanical ventilation who do not survive to ICU discharge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of time spent in different ranges of ΔPes (low, safe, and high) during the active breathing phase between the two groups
Time Frame: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
The defined "safe" range for ΔPes was -5 to -10 cm H2O. Effort outside the defined "safe" range was categorized as "low" if it fell below the lower limit, or "high" if it exceeded the upper limit of the safe range for the variable.
From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
Proportion of time spent in different ranges of Pmus (low, safe, and high) during the active breathing phase between the two groups
Time Frame: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
The defined "safe" range for Pmus was 5 to 15 cm H2O. Effort outside the defined "safe" range was categorized as "low" if it fell below the lower limit, or "high" if it exceeded the upper limit of the safe range for the variable.
From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
Proportion of time spent in different ranges of ΔPdi (low, safe, and high) during the active breathing phase between the two groups
Time Frame: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
The defined "safe" range for ΔPdi was 3 to 12 cm H2O. Effort outside the defined "safe" range was categorized as "low" if it fell below the lower limit, or "high" if it exceeded the upper limit of the safe range for the variable.
From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
Median value of ΔPes during the active breathing phase between the two groups
Time Frame: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
To analyze the median value of ΔPes during the active breathing phase between the two groups in cm H20.
From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
Median value of Pmus during the active breathing phase between the two groups
Time Frame: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
To analyze the median value of Pmus during the active breathing phase between the two groups in cm H20.
From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
Median value of ΔPdi during the active breathing phase between the two groups
Time Frame: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
To analyze the median value of ΔPdi during the active breathing phase between the two groups in cm H20.
From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The need for the use of venovenous (VV) extracorporeal membrane oxygenation (ECMO)
Time Frame: From date of initiation of invasive mechanical ventilation until extubation or date of death from any cause, whichever came first, assessed up to 24 months
Initiation of VV ECMO during the mechanical ventilation period (yes or no)
From date of initiation of invasive mechanical ventilation until extubation or date of death from any cause, whichever came first, assessed up to 24 months
The need for the use of extracorporeal CO2 removal (ECCO2R)
Time Frame: From date of initiation of invasive mechanical ventilation until extubation or date of death from any cause, whichever came first, assessed up to 24 months
Initiation of ECCO2R during the mechanical ventilation period (yes or no)
From date of initiation of invasive mechanical ventilation until extubation or date of death from any cause, whichever came first, assessed up to 24 months
The need for a Tracheostomy
Time Frame: From date of initiation of invasive mechanical ventilation until extubation or date of death from any cause, whichever came first, assessed up to 24 months
The need to perfom a tracheostomy duduring the mechanical ventilation period (yes or no)
From date of initiation of invasive mechanical ventilation until extubation or date of death from any cause, whichever came first, assessed up to 24 months
Duration of invasive mechanical ventilation (IMV)
Time Frame: From date of initiation of invasive mechanical ventilation until extubation or date of death from any cause, whichever came first, assessed up to 24 months
Duration of IMV measured in days
From date of initiation of invasive mechanical ventilation until extubation or date of death from any cause, whichever came first, assessed up to 24 months
Intensive care Unit (ICU) Length of stay
Time Frame: From date of ICU admission until date of ICU discharge or date of death from any cause, whichever came first, assessed up to 24 months
Duration of the ICU admission measured in days
From date of ICU admission until date of ICU discharge or date of death from any cause, whichever came first, assessed up to 24 months
Hospital Length of stay
Time Frame: From date of Hospital admission until date of Hospital discharge or date of death from any cause, whichever came first, assessed up to 24 months
Duration of the Hospital admission measured in days
From date of Hospital admission until date of Hospital discharge or date of death from any cause, whichever came first, assessed up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital del Mar Research Institute (IMIM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

June 25, 2024

First Submitted That Met QC Criteria

July 5, 2024

First Posted (Actual)

July 8, 2024

Study Record Updates

Last Update Posted (Estimated)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/9742

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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