Analysis of Advanced Physiological Ventilatory Parameters During Spontaneous Breathing Effort in Patients With Acute Hypoxemic Respiratory Failure
NCT Number: NCT06490523
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Acute Hypoxic Respiratory Failure
Sponsor: Hospital del Mar Research Institute (IMIM)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 31
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-12-01
Completion Date: 2022-11-30
Locations: Hospital del Mar, Barcelona, Catalunya, 08003, Spain

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.

Primary Outcome Measures: 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 Outcome Measures: The need for the use of venovenous (VV) extracorporeal membrane oxygenation (ECMO), 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), 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, 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), 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, 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, 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