Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2025-12-26 @ 2:25 AM
Study NCT ID:
NCT05378802
Status:
COMPLETED
Last Update Posted:
2023-08-15
First Post:
2021-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predict Transpulmonary Pressure Through ZAM
Sponsor:
Southeast University, China
Organization:
Study Overview
Official Title:
Comparison of Spontaneous Breathing and Controlled Ventilation
Status:
COMPLETED
Status Verified Date:
2023-08
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:
Stable patient with ARF spontaneously breathing light sedation (not too awake but with stable breathing pattern) and EAdi \>8 uV. Four modes of mechanical ventilation were performed under different support level for the measuring of EAdi, air way pressure and other parameters.
Detailed Description:
1. Mode NAVA spontaneous breathing select a NAVA level that gives peak pressure about 9-10 cm H2O assist keep NAVA level for 15 minutes, do ZAM breaths every 3 minutes (make sure not to disturb the patient). Insp Hold after every ZAM.
Increase NAVA level by 50% and repeat the protocol when patient's breathing has stabilized (only one increase).Do ZAM breaths every 3 minutes (make sure not to disturb the patient). Insp Hold after every ZAMAt the end of protocol (minute 15) do one end-inspiratory hold-maneuver and one end-expiratory occlusion.
2. Mode N- PSV spontaneous breathing :PS level of 8-10 cmH2O, keep PS level for 15 minutes, do ZAM every 3 minutes (make sure not to disturb patient). Inspiratory Hold after every ZAM。At the end of protocol (minute 15) do one end-inspiratory hold-maneuver and one end-expiratory occlusion.Increase PS by 50% and repeat protocol when patient's breathing has stabilized (only 1 increase). Do ZAM every 3 minutes (make sure not to disturb patient). Inspiratory Hold after every ZAM.At the end of protocol (minute 15) do one end-inspiratory hold-maneuver and one end-expiratory occlusion.
Make record of RR, Vt, Flow, Ti during both periods.
3. Mode VCV no spontaneous breathing：Set Vt, Ti and RR to match the breathing pattern observed during NAVA
4. Mode PCV no spontaneous breathing-do ZAM after each PS level：Increase PSV level from 8 to 20 in steps of 1 cmH2O every 2 minutes.
Increase NAVA level by 50% and repeat the protocol when patient's breathing has stabilized (only one increase).Do ZAM breaths every 3 minutes (make sure not to disturb the patient). Insp Hold after every ZAMAt the end of protocol (minute 15) do one end-inspiratory hold-maneuver and one end-expiratory occlusion.
2. Mode N- PSV spontaneous breathing :PS level of 8-10 cmH2O, keep PS level for 15 minutes, do ZAM every 3 minutes (make sure not to disturb patient). Inspiratory Hold after every ZAM。At the end of protocol (minute 15) do one end-inspiratory hold-maneuver and one end-expiratory occlusion.Increase PS by 50% and repeat protocol when patient's breathing has stabilized (only 1 increase). Do ZAM every 3 minutes (make sure not to disturb patient). Inspiratory Hold after every ZAM.At the end of protocol (minute 15) do one end-inspiratory hold-maneuver and one end-expiratory occlusion.
Make record of RR, Vt, Flow, Ti during both periods.
3. Mode VCV no spontaneous breathing：Set Vt, Ti and RR to match the breathing pattern observed during NAVA
4. Mode PCV no spontaneous breathing-do ZAM after each PS level：Increase PSV level from 8 to 20 in steps of 1 cmH2O every 2 minutes.
Study Oversight
Has Oversight DMC:
False
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?: