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| Name | Class |
|---|---|
| NHS Lothian | OTHER_GOV |
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The aims of the study is to determine if end-tidal concentrations of the anaesthetic gases isoflurane and sevoflurane as measured by a standard gas monitor are related to the blood levels during one-lung ventilation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lung Surgery with One-Lung Ventilation | A single cohort of patients undergoing one-lung ventilation during lung surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung Surgery with One-Lung Ventilation | Procedure | A single cohort of patients undergoing one-lung ventilation during lung surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between Blood and End-tidal Isoflurane or Sevoflurane Concentration During One-lung Ventilation | The significance of the correlation between blood and end-tidal isoflurane or sevoflurane concentration during one-lung ventilation | 10 minutes after start of one-lung ventilation |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between Bispectral Index (BIS) and End-tidal Isoflurane or Sevoflurane Concentration During One-lung Ventilation. | The significance of the correlation between BIS and end-tidal isoflurane or sevoflurane concentration during one-lung ventilation. | 10 minutes after start of one-lung ventilation |
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Inclusion Criteria:
Exclusion Criteria:
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Patients scheduled to undergo elective lung surgery with planned one-lung ventilation, identified from the operative list of a university hospital
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| Name | Affiliation | Role |
|---|---|---|
| R P Alston, MBChB,FRCA | University of Edinburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Infirmary of Edinburgh | Edinburgh | EH16 4SA | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lung Surgery With One-Lung Ventilation | A single cohort of patients undergoing one-lung ventilation during lung surgery Lung Surgery with One-Lung Ventilation: A single cohort of patients undergoing one-lung ventilation during lung surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lung Surgery With One-Lung Ventilation | A single cohort of patients undergoing one-lung ventilation during lung surgery Lung Surgery with One-Lung Ventilation: A single cohort of patients undergoing one-lung ventilation during lung surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Correlation Between Blood and End-tidal Isoflurane or Sevoflurane Concentration During One-lung Ventilation | The significance of the correlation between blood and end-tidal isoflurane or sevoflurane concentration during one-lung ventilation | Posted | Number | Correlation coefficient | 10 minutes after start of one-lung ventilation |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lung Surgery With One-Lung Ventilation | A single cohort of patients undergoing one-lung ventilation during lung surgery Lung Surgery with One-Lung Ventilation: A single cohort of patients undergoing one-lung ventilation during lung surgery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| E Alexandra Page | University of Edinburgh | 7938645122 | s1305565@sms.ed.ac.uk |
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| ID | Term |
|---|---|
| D013510 | Pulmonary Surgical Procedures |
| D061810 | One-Lung Ventilation |
| ID | Term |
|---|---|
| D019616 | Thoracic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
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2 10mL whole blood samples per patient
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Secondary | Correlation Between Bispectral Index (BIS) and End-tidal Isoflurane or Sevoflurane Concentration During One-lung Ventilation. | The significance of the correlation between BIS and end-tidal isoflurane or sevoflurane concentration during one-lung ventilation. | Data not collected due to insufficient use of Bispectral Index Monitors and temperature monitors by anaesthetists responsible for the study participants at the study site. | Posted | 10 minutes after start of one-lung ventilation |
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| 0 |
| 19 |
| 0 |
| 19 |
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| D013812 | Therapeutics |