Respiratory Volume Measure Using ExSpiron 1Xi

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.

Study Overview

• Status: Completed
• Conditions: ICU(Intensive Care Unit) Patients; Mechanical Ventilation After Surgery
• Intervention / Treatment: Device: Respiratory Volume Monitor(RVM); Device: artificial respirator

Detailed Description

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.

In addition, the investigators investigated the decrease in respiratory volume in opioid infusion after ventilator weaning in this patient, and to measure the one-time respiratory volume change by RVM during deep breathing induction using Inspirometry exercise.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Respiratory monitoring group

Device: Respiratory Volume Monitor(RVM); 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.; Other Names: ExSpiron™ 1Xi; Device: artificial respirator; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 6, 2016
• Primary Completion (ACTUAL): February 15, 2017
• Study Completion (ACTUAL): February 15, 2017

Study Registration Dates

• First Submitted: December 13, 2016
• First Submitted That Met QC Criteria: December 15, 2016
• First Posted (ESTIMATE): December 20, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 15, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 1-2016-0008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED