Study on the Patient-Ventilator Asynchrony Analysis Function

April 29, 2024 updated by: Ming Zhong
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Incidence of patient-computer dyssynchrony events: defined as the proportion of patient-computer dyssynchrony events in the total number of cycles during the patient trial. The observation period began 48 hours after the participants met the inclusion and exclusion criteria and signed the informed consent, and the data collection was stopped 48 hours later.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Yaxiaerjiang Muhetaer
  • Phone Number: +86-15021891200
  • Email: yaxxar@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: With PVAs group
With the assistance of PVA function, researchers identify the patient-ventilator asynchronies and take actions to reduce the asynchronies.
Device: PVA recognition function
Ventilator with the function of identify and judge PVAs
No Intervention: Without PVAs group
PVA function is not utilized in this arm, researchers identify the patient-ventilator asynchronies by their own and take actions to reduce the asynchronies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of PVAs
Time Frame: 48 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of PVAs that were identified by the investigator among the total PVAs during the trial
Time Frame: 48 hours
48 hours
Incidence of PVA within half an hour before and after the intervention
Time Frame: Half an hour before and after the intervention
Half an hour before and after the intervention
Accuracy of PVA recognition function
Time Frame: 48 hours
Compare manual audit and machine judgment
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ming Zhong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 20, 2024

Primary Completion (Estimated)

August 20, 2024

Study Completion (Estimated)

December 24, 2024

Study Registration Dates

First Submitted

April 18, 2024

First Submitted That Met QC Criteria

April 29, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 29, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • B2024-082

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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