Ignite Creation Date:
2024-07-17 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06490523
Status:
COMPLETED
Last Update Posted:
2024-07-08
First Post:
2024-06-25
Brief Title:
Analysis of Advanced Physiological Ventilatory Parameters During Spontaneous Breathing Effort in Patients With Acute Hypoxemic Respiratory Failure
Sponsor:
Hospital del Mar Research Institute IMIM
Organization:
Hospital del Mar Research Institute IMIM
Study Overview
Official Title:
Analysis of Advanced Physiological Ventilatory Parameters During Spontaneous Breathing Effort in Patients With Acute Hypoxemic Respiratory Failure
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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
The investigators hypothesized that AHRF patients on IMV with better outcome ie 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None