Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06344234
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-27
Brief Title:
Non-invasive Assessment of Inspiratory Effort and Tidal Distension During Non-invasive Ventilation INSPIRE
Sponsor:
University of Bari
Organization:
University of Bari
Study Overview
Official Title:
Noninvasive Assessment of Inspiratory Effort and Tidal Distension During Noninvasive Ventilation The INSPIRE Study
Status:
RECRUITING
Status Verified Date:
2024-03
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:
INSPIRE
Brief Summary:
The goal of this observational study is to evaluate whether the airway occlusion pressure recorded during a sudden end-expiratory breath-hold ΔPocc is correlated with esophageal swing in pressure and the reliability of P01 driving pressure plateau pressure pressure-muscle index and diaphragm ultrasound as noninvasive estimates of inspiratory effort and lung distension in hypoxemic patients undergoing NIV
The main questions this trial aims to answer are
- Primary Outcome whether the airway occlusion pressure recorded during a sudden end-expiratory breath-hold ΔPocc is correlated with esophageal swing in pressure and the reliability of various noninvasive estimates of inspiratory effort and lung distension in hypoxemic patients undergoing NIV
Secondary outcomes will include
Statistic metric of association between P01 ΔP PMI and ΔPes
Statistic metric of association between P01 ΔPocc ΔP PMI and PaO2FiO2 ratio
Statistic metric of association between P01 ΔPocc ΔP PMI and tidal volume
Statistic metric of association between P01 ΔPocc ΔP PMI and DTF
Statistic metric of association between P01 ΔPocc ΔP PMI and ExDTF
Statistic metric of association between P01 ΔPocc ΔP PMI and respiratory rate VAS dyspnea and VAS discomfort
Participants will undergo the following tasks and treatments
Complete written informed consent before enrollment
Post-extubation noninvasive ventilation via nose-to-mouth and full-face masks
Monitoring of esophageal pressure in all patients the catheter will be placed before extubation according to clinical judgment and its correct position will be verified through a positive pressure occlusion test
Continuous recording of airway pressure flow and esophageal pressure Pes using a dedicated pneumotachograph and pressure transducer
Sudden end-inspiratory and end-expiratory occlusion maneuvers to measure plateau pressure Pplat and end-expiratory airway occlusion pressure ΔPocc respectively
Collection of hemodynamic and arterial blood-gas parameters performed according to clinical judgment along with assessments of dyspnea and discomfort using a modified visual analogue scale VAS
Diaphragm ultrasound during occlusion maneuvers measuring diaphragm displacement diaphragm thickening fraction DTF and diaphragmatic excursion Ex under various conditions
The main questions this trial aims to answer are
- Primary Outcome whether the airway occlusion pressure recorded during a sudden end-expiratory breath-hold ΔPocc is correlated with esophageal swing in pressure and the reliability of various noninvasive estimates of inspiratory effort and lung distension in hypoxemic patients undergoing NIV
Secondary outcomes will include
Statistic metric of association between P01 ΔP PMI and ΔPes
Statistic metric of association between P01 ΔPocc ΔP PMI and PaO2FiO2 ratio
Statistic metric of association between P01 ΔPocc ΔP PMI and tidal volume
Statistic metric of association between P01 ΔPocc ΔP PMI and DTF
Statistic metric of association between P01 ΔPocc ΔP PMI and ExDTF
Statistic metric of association between P01 ΔPocc ΔP PMI and respiratory rate VAS dyspnea and VAS discomfort
Participants will undergo the following tasks and treatments
Complete written informed consent before enrollment
Post-extubation noninvasive ventilation via nose-to-mouth and full-face masks
Monitoring of esophageal pressure in all patients the catheter will be placed before extubation according to clinical judgment and its correct position will be verified through a positive pressure occlusion test
Continuous recording of airway pressure flow and esophageal pressure Pes using a dedicated pneumotachograph and pressure transducer
Sudden end-inspiratory and end-expiratory occlusion maneuvers to measure plateau pressure Pplat and end-expiratory airway occlusion pressure ΔPocc respectively
Collection of hemodynamic and arterial blood-gas parameters performed according to clinical judgment along with assessments of dyspnea and discomfort using a modified visual analogue scale VAS
Diaphragm ultrasound during occlusion maneuvers measuring diaphragm displacement diaphragm thickening fraction DTF and diaphragmatic excursion Ex under various conditions
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
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