Predict Transpulmonary Pressure Through ZAM

NCT ID: NCT05378802

Last Updated: 2023-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2023-08-10

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.

Conditions

Acute Respiratory Failure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

NAVA mode

1. 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

2. 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

Group Type: EXPERIMENTAL

different modes of mechanical ventilation

Intervention Type: OTHER

Four different ventilation modes were performed one by one and respiratory parameters were recorded.

N- PSV mode

1. 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.

2. 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

Group Type: EXPERIMENTAL

different modes of mechanical ventilation

Intervention Type: OTHER

Four different ventilation modes were performed one by one and respiratory parameters were recorded.

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.

Group Type: ACTIVE_COMPARATOR

different modes of mechanical ventilation

Intervention Type: OTHER

Four different ventilation modes were performed one by one and respiratory parameters were recorded.

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.

Group Type: ACTIVE_COMPARATOR

different modes of mechanical ventilation

Intervention Type: OTHER

Four different ventilation modes were performed one by one and respiratory parameters were recorded.

Interventions

different modes of mechanical ventilation

Four different ventilation modes were performed one by one and respiratory parameters were recorded.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southeast University, China

OTHER

Sponsor Role: lead

Responsible Party

Ling Liu

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haibo Qiu

Role: PRINCIPAL_INVESTIGATOR

Southeast University

Locations

Zhongda hospital, Southeast university

Nanjing, Jiangsu, China

Countries

China

References

Liu L, He H, Liang M, Beck J, Sinderby C. Estimation of transpulmonary driving pressure using a lower assist maneuver (LAM) during synchronized ventilation in patients with acute respiratory failure: a physiological study. Intensive Care Med Exp. 2024 Oct 4;12(1):89. doi: 10.1186/s40635-024-00674-z.

Reference Type: DERIVED

PMID: 39365383 (View on PubMed)

Other Identifiers

ZAM study

Identifier Type: -

Identifier Source: org_study_id