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

NCT01354769 | Completed

• 1 other identifier: D0006746A
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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

Conditions

Respiratory Insufficiency

Study Arms (2)

Non-intubated patients

Device: CapnoStream20

Intubated patients

Device: CapnoStream20

Interventions

CapnoStream20 DEVICE

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

Also known as: Capnostream Bedside Monitor, Oridion Medical Ltd.

Intubated patients; Non-intubated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Sharon Einav-Bromiker, MD

  Shaare Zedek Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2011
• First Posted: May 17, 2011
• Study Start: June 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: January 1, 2015
• Last Updated: April 26, 2016

Record last verified: 2011-05

Locations

IL (1)