Clinical trial NCT02821455: Estimating Blood Concentrations of Anaesthetics During One-Lung Ventilation (OLV)
Official title: Does the End-tidal Concentration Estimate the Blood Concentration of Inhalational Anaesthetics During One-lung Ventilation?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: One-Lung Ventilation
Keywords: Isoflurane
Sevoflurane
Bispectral Index
Pulmonary Surgical Procedures
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
First posted: 2016-07-01
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled to undergo elective lung surgery with planned one-lung ventilation, identified from the operative list of a university hospital

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation Between Blood and End-tidal Isoflurane or Sevoflurane Concentration During One-lung Ventilation
timeFrame: 10 minutes after start of one-lung ventilation
Secondary outcomes:
measure: Correlation Between Bispectral Index (BIS) and End-tidal Isoflurane or Sevoflurane Concentration During One-lung Ventilation.
timeFrame: 10 minutes after start of one-lung ventilation
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
Study officials:
affiliation: University of Edinburgh
name: R P Alston, MBChB,FRCA
role: PRINCIPAL_INVESTIGATOR
References: