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Estimating Blood Concentrations of Anaesthetics During One-Lung Ventilation (OLV)

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ClinicalTrials.gov Identifier: NCT02821455
Recruitment Status : Completed
First Posted : July 1, 2016
Results First Posted : August 2, 2018
Last Update Posted : August 2, 2018
Sponsor:
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh

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.

Condition or disease Intervention/treatment
One-Lung Ventilation Procedure: Lung Surgery with 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.


Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does the End-tidal Concentration Estimate the Blood Concentration of Inhalational Anaesthetics During One-lung Ventilation?
Study Start Date : August 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : January 2017

Group/Cohort Intervention/treatment
Lung Surgery with One-Lung Ventilation
A single cohort of patients undergoing one-lung ventilation during lung surgery
Procedure: Lung Surgery with One-Lung Ventilation
A single cohort of patients undergoing one-lung ventilation during lung surgery




Primary Outcome Measures :
  1. Correlation Between Blood and End-tidal Isoflurane or Sevoflurane Concentration During One-lung Ventilation [ Time Frame: 10 minutes after start of one-lung ventilation ]
    The significance of the correlation between blood and end-tidal isoflurane or sevoflurane concentration during one-lung ventilation


Secondary Outcome Measures :
  1. 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 ]
    The significance of the correlation between BIS and end-tidal isoflurane or sevoflurane concentration during one-lung ventilation.


Biospecimen Retention:   Samples With DNA
2 10mL whole blood samples per patient


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02821455


Locations
United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom, EH16 4SA
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Investigators
Principal Investigator: R P Alston, MBChB,FRCA University of Edinburgh

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT02821455     History of Changes
Other Study ID Numbers: AC16081
First Posted: July 1, 2016    Key Record Dates
Results First Posted: August 2, 2018
Last Update Posted: August 2, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Edinburgh:
Isoflurane
Sevoflurane
Bispectral Index
Pulmonary Surgical Procedures

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs