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

NCT06490523 | Completed

• 1 other identifier: 2021/9742
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Hypoxic Respiratory Failure

Outcome Measures

Primary Outcomes (6)

• Proportion of time spent in different ranges of ΔPes (low, safe, and high) during the active breathing phase between the two groups

  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

  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

  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

  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

  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

  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 Outcomes (6)

• 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 months

• 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 months

• The need for a Tracheostomy

  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)

  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

  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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Acute hypoxemic respiratory failure patients requiring invasive mechanical ventialtion

You may not qualify if:

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

Sponsors & Collaborators

• Hospital del Mar Research Institute (IMIM): lead

Study Sites (1)

Hospital del Mar

Barcelona, Catalonia, 08003, Spain

Location

Related Publications (17)

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  PMID: 40758388 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Investigator

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 8, 2024
• Study Start: December 1, 2020
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: November 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)