Predict Transpulmonary Pressure Through ZAM

Acute Respiratory Failure Clinical Trial

Official title:

Comparison of Spontaneous Breathing and Controlled Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05378802
• Other study ID #: ZAM study
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: August 10, 2023

Study information

• Verified date: August 2023
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 10, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Stable patient with acute respiratory failure on invasive mechanical ventilation Can tolerate pressure support ventilation light sedation with RASS between -2 and 1

Exclusion Criteria:

• EAdi<8 uV contraindication for nasogastric tube insertion neuromuscular disease affecting spontaneous breathing lack of informed consent, and patients included in other intervention study

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• different modes of mechanical ventilation
Four different ventilation modes were performed one by one and respiratory parameters were recorded.

Locations

Country	Name	City	State
China	Zhongda hospital, Southeast university	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predicted transpulmonary pressure	Transpulmonary pressure calculated from airway pressure by Prediction formula	6 hours
Secondary	patient-ventilator breath contribution	An index for quantifying the respective patient and ventilator breath contributions	6 hours
Secondary	inspiratory flow	the inspiratory flow measured by the ventilator	6 hours