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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02821455
Other study ID # AC16081
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2016
Est. completion date January 2017

Study information

Verified date October 2017
Source University of Edinburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date January 2017
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Lung Surgery with One-Lung Ventilation
A single cohort of patients undergoing one-lung ventilation during lung surgery

Locations

Country Name City State
United Kingdom Royal Infirmary of Edinburgh Edinburgh

Sponsors (2)

Lead Sponsor Collaborator
University of Edinburgh NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
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 10 minutes after start of one-lung ventilation
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. 10 minutes after start of one-lung ventilation
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