NCT02998294

Brief Summary

The purpose of this study was to determine the accuracy of one-time respiratory volume measured by RVM(Respiratory Volume Monitor) compared to the one-time respiratory volume measured by mechanical ventilation in post-operative ICU patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 20, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2017

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

11 months

First QC Date

December 13, 2016

Last Update Submit

July 15, 2018

Conditions

ICU(Intensive Care Unit) PatientsMechanical Ventilation After Surgery

Outcome Measures

Primary Outcomes (1)

  • Respiratory volume measure using ExSpiron 1Xi

    During mechanical ventilator, we obtained respiratory parameter from ventilator and also we collected same parameter via RVM.

    during 10-minute

Study Arms (1)

Respiratory monitoring group

EXPERIMENTAL
Device: Respiratory Volume Monitor(RVM)Device: artificial respirator

Interventions

Respiratory Volume Monitor(RVM)DEVICE

The purpose of this study was to determine the accuracy of one-time respiratory volume measured by RVM compared to the one-time respiratory volume measured by mechanical ventilation in post-operative ICU patients.

Also known as: ExSpiron™ 1Xi
Respiratory monitoring group
artificial respiratorDEVICE

The purpose of this study was to determine the accuracy of one-time respiratory volume measured by RVM compared to the one-time respiratory volume measured by mechanical ventilation in post-operative ICU patients.

Respiratory monitoring group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • An adult patients ( ≥ age 19)
  • patients who receive mechanical ventilation in the ICU of the Severance Hospital after surgery and plans to wean the mechanical ventilation within 3 days.

You may not qualify if:

  • severe respiratory illness patients (pneumothorax, chest tube intubation status, severe restrictive respiratory disease, unilateral lung ventilation, lung transplantation status, chronic restrictive respiratory disease, hydrothorax, diaphragmatic movement disorder)
  • If the candidate can not understand and carry out the experiment contents and process

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

MeSH Terms

Interventions

Ventilators, Mechanical

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2016

First Posted

December 20, 2016

Study Start

April 6, 2016

Primary Completion

February 15, 2017

Study Completion

February 15, 2017

Last Updated

July 18, 2018

Record last verified: 2018-07

Locations

KR(1)