Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06490523
Enrollment
31
Registered
2024-07-08
Start date
2020-12-01
Completion date
2022-11-30
Last updated
2024-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Hypoxic Respiratory Failure

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.

Interventions

None listed

Sponsors

Hospital del Mar Research Institute (IMIM)
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Median value of ΔPdi during the active breathing phase between the two groupsFrom 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.
Proportion of time spent in different ranges of ΔPes (low, safe, and high) during the active breathing phase between the two groupsFrom 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.
Proportion of time spent in different ranges of Pmus (low, safe, and high) during the active breathing phase between the two groupsFrom 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.
Proportion of time spent in different ranges of ΔPdi (low, safe, and high) during the active breathing phase between the two groupsFrom 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.
Median value of ΔPes during the active breathing phase between the two groupsFrom 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.
Median value of Pmus during the active breathing phase between the two groupsFrom 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.

Secondary

MeasureTime frameDescription
The need for the use of venovenous (VV) extracorporeal membrane oxygenation (ECMO)From date of initiation of invasive mechanical ventilation until extubation or date of death from any cause, whichever came first, assessed up to 24 monthsInitiation of VV ECMO during the mechanical ventilation period (yes or no)
The need for the use of extracorporeal CO2 removal (ECCO2R)From date of initiation of invasive mechanical ventilation until extubation or date of death from any cause, whichever came first, assessed up to 24 monthsInitiation of ECCO2R during the mechanical ventilation period (yes or no)
The need for a TracheostomyFrom date of initiation of invasive mechanical ventilation until extubation or date of death from any cause, whichever came first, assessed up to 24 monthsThe need to perfom a tracheostomy duduring the mechanical ventilation period (yes or no)
Duration of invasive mechanical ventilation (IMV)From date of initiation of invasive mechanical ventilation until extubation or date of death from any cause, whichever came first, assessed up to 24 monthsDuration of IMV measured in days
Intensive care Unit (ICU) Length of stayFrom date of ICU admission until date of ICU discharge or date of death from any cause, whichever came first, assessed up to 24 monthsDuration of the ICU admission measured in days
Hospital Length of stayFrom date of Hospital admission until date of Hospital discharge or date of death from any cause, whichever came first, assessed up to 24 monthsDuration of the Hospital admission measured in days

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026