Clinical trial NCT06490523: Analysis of Advanced Physiological Ventilatory Parameters During Spontaneous Breathing Effort in Patients with Acute Hypoxemic Respiratory Failure
Official title: Analysis of Advanced Physiological Ventilatory Parameters During Spontaneous Breathing Effort in Patients with Acute Hypoxemic Respiratory Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Hypoxic Respiratory Failure
Lead sponsor: Hospital del Mar Research Institute (IMIM)
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Proportion of time spent in different ranges of ΔPes (low, safe, and high) during the active breathing phase between the two groups
timeFrame: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
measure: Proportion of time spent in different ranges of Pmus (low, safe, and high) during the active breathing phase between the two groups
timeFrame: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
measure: Proportion of time spent in different ranges of ΔPdi (low, safe, and high) during the active breathing phase between the two groups
timeFrame: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
measure: Median value of ΔPes during the active breathing phase between the two groups
timeFrame: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
measure: Median value of Pmus during the active breathing phase between the two groups
timeFrame: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
measure: Median value of ΔPdi during the active breathing phase between the two groups
timeFrame: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
Secondary outcomes:
measure: The need for the use of venovenous (VV) extracorporeal membrane oxygenation (ECMO)
timeFrame: 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
measure: The need for the use of extracorporeal CO2 removal (ECCO2R)
timeFrame: 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
measure: The need for a Tracheostomy
timeFrame: 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
measure: Duration of invasive mechanical ventilation (IMV)
timeFrame: 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
measure: Intensive care Unit (ICU) Length of stay
timeFrame: 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
measure: Hospital Length of stay
timeFrame: 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
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
state: Catalunya
Study officials:
References:
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