Novel Non-Invasive Monitoring Parameter in a Hospital Setting

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01306201
First received: February 10, 2011
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

Data collected from this study will be used to evaluate the performance of a monitoring algorithm.


Condition
Respiratory Insufficiency
Respiratory Failure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Novel Cardio-Respiratory Parameter in a Hospital Setting

Resource links provided by NLM:


Further study details as provided by Covidien:

Primary Outcome Measures:
  • The Covidien Nellcor Respiration Rate Software Shall Determine Respiration Rate Measured as Mean and Standard Deviation With Accuracy That is Non-inferior to Predicate Device. [ Time Frame: Participants were monitored for average of 30 minutes ] [ Designated as safety issue: No ]
    Mean and standard deviations of respiration rates collected from patients in the hospital settings were compared between Covidien Respiration Rate Software, Transthoracic Impedance and End-Tidal Carbon Dioxide Waveforms. Each patient served as its own control.


Secondary Outcome Measures:
  • The Covidien Nellcor Respiration Rate Software Shall Calculate Respiration Rate With a Root Mean Square Difference (RMSD) of < 3 Breaths Per Minute Compared With a End-Tidal Carbon Dioxide Waveforms, With 95% Confidence. [ Time Frame: Participants were monitored on average for 30 minutes ] [ Designated as safety issue: No ]

    The data used for analysis consisted of multiple simultaneous measures of RR_TTI, RR_V1.0 and RR_EtCO2 for each subject. Given N sets of simultaneous RR values for each of P patients, the simultaneous RR values were used to calculate a pair of RMSD values for each subject.

    The two RMSD values, RMSDRR_V1.0_vs_EtCO2, and RMSDTTI_vs_EtCO2, quantify the mean absolute difference in simultaneous estimates of respiratory rate between RR_V1.0 compared with RR_EtCO2 and RR_TTI compared with RR_EtCO2, respectively for the subjects with 95% confidence of mean ± 3.38 BrPM. The Measure type is Number and represents the RMSD of Covidien Nellcor Respiration Rate Software



Enrollment: 63
Study Start Date: February 2011
Study Completion Date: March 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
In-patient Volunteers
In-patients from the hospital who choose to participate in the study

Detailed Description:

The goal of this study is to assess equivalency, performance, and accuracy of a new monitoring algorithm in a hospital setting.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

General Care Floor Patients

Criteria

Inclusion Criteria:

  1. Subjects 18 years old or older
  2. Written informed consent from the patient or their legally authorized representative before initiation of any study-related procedures
  3. Subjects on general care floor

Exclusion Criteria:

  1. Severe contact allergies to standard adhesive materials
  2. Abnormalities that may prevent proper application of the device
  3. Women who are pregnant or lactating
  4. Subjects with significant arrhythmia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01306201

Locations
United States, Colorado
The University of Colorado Health Sciences Center (UCHSC)
Denver, Colorado, United States, 80262
United States, Ohio
The Ohio State University Medical Center (OSUMC)
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Covidien
Investigators
Principal Investigator: Sergio Bergese, MD The Ohio State Medical Center, Dept of Anesthesia
Principal Investigator: Robert McIntyre, MD University of Colorado Denver, School of Medicine dept of Surgery Division of GI, Tumor and Endocrine Surgery
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01306201     History of Changes
Other Study ID Numbers: COVMOPR0131
Study First Received: February 10, 2011
Results First Received: May 2, 2012
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Covidien:
Hospital Setting

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 19, 2014