Predict Transpulmonary Pressure Through ZAM

NCT05378802 | Completed

• 1 other identifier: ZAM study
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Predicted transpulmonary pressure

  Transpulmonary pressure calculated from airway pressure by Prediction formula

  6 hours

Secondary Outcomes (2)

• patient-ventilator breath contribution

  6 hours

• inspiratory flow

  6 hours

Study Arms (4)

NAVA mode

EXPERIMENTAL

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

Other: different modes of mechanical ventilation

N- PSV mode

EXPERIMENTAL

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

Other: different modes of mechanical ventilation

VCV mode

ACTIVE COMPARATOR

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

PCV mode

ACTIVE COMPARATOR

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

Interventions

different modes of mechanical ventilation OTHER

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

N- PSV mode; NAVA mode; PCV mode; VCV mode

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Zhongda hospital, Southeast university

Nanjing, Jiangsu, 210009, China

Location

Related Publications (1)

• 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.

  PMID: 39365383 DERIVED

Study Officials

• Haibo Qiu

  Southeast University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 6, 2021
• First Posted: May 18, 2022
• Study Start: November 1, 2021
• Primary Completion: August 1, 2023
• Study Completion: August 10, 2023
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)