Study on the Patient-Ventilator Asynchrony Analysis Function

NCT06390917 | Not Yet Recruiting

• 1 other identifier: B2024-082
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study, the incidence of patient-ventilator asynchronism in two groups of patients was studied when the ventilator was prompted by the PVA asynchronism analysis function

Conditions

To Study the Incidence of Patient-ventilator Asynchronization in Two Groups of Patients Under Two Conditions With PVA Unsynchronization Analysis Function

Outcome Measures

Primary Outcomes (1)

• Incidence rate of PVAs

  Percentage of the number of respiratory cycles in which human-machine asynchronous events occurred in the total number of respiratory cycles in each patient during the trial

  48 hours

Secondary Outcomes (3)

• The proportion of PVAs that were identified by the investigator among the total PVAs during the trial

  48 hours

• Incidence of PVA within half an hour before and after the intervention

  Half an hour before and after the intervention

• Accuracy of PVA recognition function

  48 hours

Study Arms (2)

With PVAs group

EXPERIMENTAL

With the assistance of PVA function, researchers identify the patient-ventilator asynchronies and take actions to reduce the asynchronies.

Device: PVA recognition function

Without PVAs group

NO INTERVENTION

PVA function is not utilized in this arm, researchers identify the patient-ventilator asynchronies by their own and take actions to reduce the asynchronies.

Interventions

PVA recognition function DEVICE

Ventilator with the function of identify and judge PVAs

With PVAs group

Eligibility Criteria

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

You may qualify if:

• Adults (≥18 years) requiring invasive mechanical ventilation
• Patiens had spontaneous breathing;
• Agreed to participate in the trial and signed an informed consent

You may not qualify if:

• Patients with contraindications to esophageal catheter insertion and inability to monitor esophageal pressure;
• pregnant women;
• patients with severe central nervous system damage or neuromuscular related diseases;
• Participating in other clinical research projects;
• Patients deemed unsuitable by the investigator

Sponsors & Collaborators

• Ming Zhong: lead

Central Study Contacts

Ming Zhong

CONTACT

+86-13817758167; zhong.ming@zs-hospital.sh.cn

Yaxiaerjiang Muhetaer

CONTACT

+86-15021891200; yaxxar@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 30, 2024
• Study Start: April 20, 2024
• Primary Completion: August 20, 2024
• Study Completion: December 24, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04