Capnography Library - Data Collection in the Critical Care Environment Stage 2

Capgnography is the monitoring of the concentration or partial pressure of carbon dioxide in the expired respiratory gases; as such, it is a non-invasive monitoring technique which allows fast and reliable insight into ventilation, circulation and metabolism. Capnography has proven to be more effective than clinical judgement alone in the early detection of adverse respiratory events. The shape of a capnogram is identical in all humans with healthy lungs; any deviations in shape must be investigated to determine a physiological or a pathological cause of the abnormality.

Data from a previous pilot study yielded two major findings:

1. Prediction of requirement for intubation, by the creation of an "Integrated Pulmonary Index" (IPI) based on non-invasive physiological parameters
2. Breathing patterns during weaning in order to identify specific patterns used to predict extubation success/failure

The intent of the current study is to gather sufficient data to either prove or disprove the findings of the previous study

Study Overview

• Status: Completed
• Conditions: Respiratory Insufficiency
• Intervention / Treatment: Device: CapnoStream20

Detailed Description

The patient's monitoring period will be as follows:

Non-intubated patients - Initiation: As soon as possible after admission and/or extubation and no later than 24 hours after either. Termination- either 2 hours after intubation or after 8 hours of monitoring overall.

Intubated patients - Initiation: No later than 24 hours after a decision to begin weaning has been made . Termination: Upon ICU (Intensive Care Unit) discharge or for the duration of 10 days at most.

Data will be collected using three tools:

1. CapnoStream raw data (CO2 (Carbon dioxide) waveform, EtCO2 (End-tidal Carbon dioxide), respiratory rate, SpO2 (Saturation of peripheral Oxygen), pulse rate, IPI, alarms, events and any other messages generated by the monitor) will be transferred from the monitor to a laptop via a dedicated recording program.
2. Ventilator data (settings and resultant patient parameters) will be transferred from the monitor to a laptop via a dedicated recording program.
3. Patient monitoring parameters (heart rate, blood pressure, CVP (Central Venous Pressure), temperature, spirometry values etc) shall be recorded from the multi parameter monitors already in use in the ICU and transferred online to a laptop using dedicated recording software.

All recorded parameters will be synchronized. Data will be recorded from at least two of the tools, the Capnostream and the ventilator.

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91031
    • Shaare Zedek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Non-intubated and intubated patients being treated for severe illnesses in the intensive care unit

Description

Inclusion Criteria:

• Over the age of 18
• Suffering from severe illness requiring admission to the ICU
• Expected to be hospitalized in the ICU for a minimum of 8 hours

Exclusion Criteria:

• Under the age of 18
• The patient's refusal to participate in the study
• Any change in the patient's condition that may interfere with data collection

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-intubated patients	Device: CapnoStream20; The monitor used for data gathering is a CapnoStream20-multi parameter monitor; Other Names: Capnostream Bedside Monitor, Oridion Medical Ltd.
Intubated patients	Device: CapnoStream20; The monitor used for data gathering is a CapnoStream20-multi parameter monitor; Other Names: Capnostream Bedside Monitor, Oridion Medical Ltd.

Collaborators and Investigators

• Sponsor: Shaare Zedek Medical Center
• Investigators: Principal Investigator: Sharon Einav-Bromiker, MD, Shaare Zedek Medical Centre

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (ACTUAL): September 1, 2014
• Study Completion (ACTUAL): January 1, 2015

Study Registration Dates

• First Submitted: May 16, 2011
• First Submitted That Met QC Criteria: May 16, 2011
• First Posted (ESTIMATE): May 17, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): April 26, 2016
• Last Update Submitted That Met QC Criteria: April 24, 2016
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: D0006746A

Plan for Individual participant data (IPD)

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