- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02821455
Estimating Blood Concentrations of Anaesthetics During One-Lung Ventilation (OLV)
Does the End-tidal Concentration Estimate the Blood Concentration of Inhalational Anaesthetics During One-lung Ventilation?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Measurement of the anaesthetic gases such as isoflurane and sevoflurane allow anaesthetists to gauge their blood levels and in turn their brain levels and so help assess how deep the patient is under anaesthesia. These measurements, made as the patient breathes out, are known as end-tidal concentrations of anesthetic gases and are routinely made with gas monitors. Measurement of blood levels of anaesthetic gases is possible but infrequently done as it is time-consuming, expensive, and requires a scientist in a laboratory with specialized equipment. Depth of anaesthesia is assessed using clinical signs along with end-tidal concentrations though more recently it can be assessed by monitoring the brain's electrical waves. This technique remains controversial.
Mechanically supporting the patient's breathing using only one of the two lungs, known as one-lung ventilation, is used in lung surgery to allow the surgeon to gain access to one side of the chest whilst the anaesthetist supports the lung on the other side. One-lung ventilation markedly alters the exchange of gases in the lungs, including anaesthetic gases. Because of this derangement, it is not known if the end-tidal concentrations are related to blood levels of anaesthetic gases during this type of mechanical ventilation. The aims of the study is to determine if end-tidal concentrations of anaesthetics as measured by a standard gas monitor are related to the blood levels of the gases isoflurane and sevoflurane during one-lung ventilation.
Patients over 18 years old undergoing planned lung surgery with one-lung ventilation and anaesthesia with isoflurane or sevoflurane, and who have a routine tube inserted into an artery in their wrist to monitor blood pressure will be recruited for the study. During the study, two blood samples the size of two teaspoons each will be taken from the tube in the artery and two end-tidal concentration recordings.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Edinburgh, United Kingdom, EH16 4SA
- Royal Infirmary of Edinburgh
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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:
- Over the age of 18
- Admitted for elective thoracic surgery using one-lung ventilation obtained by the use of a double-lumen endotracheal tube or bronchial blocker.
- Elective surgery planned between 1 August and 30 November 2016
- Planned insertion of an arterial cannula by anaesthetist for routine monitoring of systemic arterial pressure
- Planned inhalational anaesthesia technique with isoflurane or sevoflurane.
- Patients who have provided consent to take part in the study
Exclusion Criteria:
- Patients under the age of 18
- History of malignant hyperthermia
- Emergency thoracic surgery
- Patients who have not consented to take part in the study
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Lung Surgery with One-Lung Ventilation
A single cohort of patients undergoing one-lung ventilation during lung surgery
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A single cohort of patients undergoing one-lung ventilation during lung surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation Between Blood and End-tidal Isoflurane or Sevoflurane Concentration During One-lung Ventilation
Time Frame: 10 minutes after start of one-lung ventilation
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The significance of the correlation between blood and end-tidal isoflurane or sevoflurane concentration during one-lung ventilation
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10 minutes after start of one-lung ventilation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation Between Bispectral Index (BIS) and End-tidal Isoflurane or Sevoflurane Concentration During One-lung Ventilation.
Time Frame: 10 minutes after start of one-lung ventilation
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The significance of the correlation between BIS and end-tidal isoflurane or sevoflurane concentration during one-lung ventilation.
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10 minutes after start of one-lung ventilation
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: R P Alston, MBChB,FRCA, University of Edinburgh
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 (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AC16081
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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