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

Respiratory Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01354769
• Other study ID #: D0006746A
• Status: Completed
• Phase: N/A
• First received: May 16, 2011
• Last updated: April 24, 2016
• Start date: June 2011
• Est. completion date: January 2015

Study information

• Verified date: May 2011
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Device:
• CapnoStream20
The monitor used for data gathering is a CapnoStream20-multi parameter monitor

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel,