Predict Transpulmonary Pressure Through ZAM

Comparison of Spontaneous Breathing and Controlled Ventilation

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Failure
• Intervention / Treatment: Other: different modes of mechanical ventilation

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital, Southeast University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NAVA mode; st 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; nd 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 ZAM	Other: different modes of mechanical ventilation; Four different ventilation modes were performed one by one and respiratory parameters were recorded.
Experimental: N- PSV mode; st PS level of 8-10 cmH2O, keep PS level for 15 minutes, do ZAM every 3 minutes (make sure not to disturb patient). Insp Hold after every ZAM At the end of protocol (minute 15) do one end-inspiratory hold-maneuver and one end-expiratory occlusion.; nd 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). Insp Hold after every ZAM	Other: different modes of mechanical ventilation; Four different ventilation modes were performed one by one and respiratory parameters were recorded.
Active Comparator: VCV mode; no spontaneous breathing Set Vt, Ti and RR to match the breathing pattern observed during NAVA. Make sure each change in "level" does not increase the pressure by more than 1 cmH2O. 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. Be careful at the higher pressures.	Other: different modes of mechanical ventilation; Four different ventilation modes were performed one by one and respiratory parameters were recorded.
Active Comparator: PCV mode; Increase PSV level from 8 to 20 in steps of 1 cmH2O every 2 minutes. Be careful at the higher pressures The idea is not to have pressures as high as 20 cmH2O, it is important to have high enough VCV & PCV flow rates so we can match the flow rates during spontaneous breathing. You might find that 15 or 16 cmH2O is enough to generate flow rates that match the "maximum" flow rate you saw during spontaneous breathing.	Other: different modes of mechanical ventilation; Four different ventilation modes were performed one by one and respiratory parameters were recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predicted transpulmonary pressure	Transpulmonary pressure calculated from airway pressure by Prediction formula	6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient-ventilator breath contribution	An index for quantifying the respective patient and ventilator breath contributions	6 hours
inspiratory flow	the inspiratory flow measured by the ventilator	6 hours

Collaborators and Investigators

• Sponsor: Southeast University, China
• Investigators: Principal Investigator: Haibo Qiu, Southeast university

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 10, 2023

Study Registration Dates

• First Submitted: November 6, 2021
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: ZAM study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a physiological study, we do not intend to disclose the data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No