- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02599350
Assessing Gas Exchange in Intensive Care Patients on a Ventilator
Evaluation of a New Computer Slide Rule Method for Assessing Gas Exchange in Intensive Care Patients on a Ventilator
Study Overview
Status
Conditions
Detailed Description
30 adult patients admitted to Aberdeen Royal Infirmary ICU, requiring invasive mechanical ventilation and with impaired gas exchange will be recruited and the following baseline demographic data will be recorded: cause of respiratory failure, APACHE II score, cardiovascular shock (presence / absence), duration of mechanical ventilation prior to inclusion, duration of respiratory failure prior to inclusion. Also the following baseline physiological data will also be recorded: FIO2, SaO2, PEEP, arterial blood pressure, central venous pressure, haemoglobin, PaO2, PaCO2, arterial pH and inotrope / vasopressor infusion rates.
The FIO2 will then be varied in random steps to 0.35, 0.4, 0.45, 0.5, 0.55, 0.6 and 0.65. After changing the FIO2 a 3-4 minute equilibration period will be allowed prior to taking an arterial blood gas sample for analysis. In the event of a PaO2 < 8kPa being recorded, further reductions in FIO2 will not be undertaken.
The data collected will then be utilised using a slide rule computer programme to generate FIO2 vs. SpO2 graphs. Other indices of gas exchange, e.g. PaO2/FIO2 ratios will also be generated from the data. Predicted versus actual PaO2 will be plotted and a correlation coefficient obtained.
Patients will then be followed for up to 5 days and depending on progression the same procedures will be repeated between days 3 and 5.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Aberdeenshire
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Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZD
- Aberdeen Royal Infirmary
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- FIO2 on enrollment = 0.4-0.6, PEEP 5cm H2O, "Stable" respiratory failure - same or less FIO2 for 2 hours prior to enrollment.
Exclusion Criteria:
- Age < 16 years
- Pregnancy
- Known intracranial disease
- Prone position
- Nitric oxide therapy
- Pneumothorax/bronchopleural fistula/intercostal drain in situ
- Severe respiratory failure (FIO2 0.7), OR
- Severe haemodynamic instability (escalating inotrope requirements, fluid resuscitation > 1 litre/hour in 2 hours prior to commencing intervention, mean arterial blood pressure < 65 mmHg).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
Patients receiving mechanical ventilation
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nigel R Webster, MB PhD, University of Aberdeen
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 09/MRE00/32
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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