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Completed

NCT Number: NCT06490523

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

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.

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Key information

Conditions

Acute Hypoxic Respiratory Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital del Mar

Barcelona, Catalonia, 08003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Hospital del Mar Research Institute (IMIM)

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 8, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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