One-Lung VentilationNCT02821455
Estimating Blood Concentrations of Anaesthetics During One-Lung Ventilation (OLV)
An observational study of One-Lung Ventilation, run by University of Edinburgh at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- One-Lung Ventilation
- What is being tested?
- Lung Surgery with One-Lung Ventilation
- Type of treatment
- Surgery or procedure
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2016to Jan 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled to undergo elective lung surgery with planned one-lung ventilation, identified from the operative list of a university hospital
Who may be able to join
- 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
Who cannot join
- Patients under the age of 18
- History of malignant hyperthermia
- Emergency thoracic surgery
- Patients who have not consented to take part in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the End-tidal Concentration Estimate the Blood Concentration of Inhalational Anaesthetics During One-lung Ventilation?
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.
Read the 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.
- Conditions
- One-Lung Ventilation
- Being tested
- Lung Surgery with One-Lung Ventilation
- Keywords
- Isoflurane, Sevoflurane, Bispectral Index, Pulmonary Surgical Procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Surgery with One-Lung VentilationProcedure or surgery
A single cohort of patients undergoing one-lung ventilation during lung surgery
| Study group | Role | What they receive |
|---|---|---|
| Lung Surgery with One-Lung Ventilation | A single cohort of patients undergoing one-lung ventilation during lung surgery Receives: Procedure: Lung Surgery with One-Lung Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 minutes after start of one-lung ventilation
Secondary outcomes (1)
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.
Measured: 10 minutes after start of one-lung ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionNov 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for One-Lung VentilationStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
- Investigators
- R P Alston, MBChB,FRCA, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821455
- Sponsor's protocol ID
- AC16081
- Status last verified
- Oct 2017
- First submitted
- 29 Jun 2016
- Last updated
- 2 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the End-tidal Concentration Estimate the Blood Concentration of Inhalational Anaesthetics During One-lung Ventilation?
- ClinicalTrials.gov ID
- NCT02821455
- Acronym / sponsor ID
- AC16081
- Conditions
- One-Lung Ventilation
- Keywords
- Isoflurane, Sevoflurane, Bispectral Index, Pulmonary Surgical Procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- Aug 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 1 Jul 2016 (estimated)
- Results
- Posted 2 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung Surgery with One-Lung Ventilation | – | Procedure: Lung Surgery with One-Lung VentilationA single cohort of patients undergoing one-lung ventilation during lung surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to undergo elective lung surgery with planned one-lung ventilation, identified from the operative list of a university hospital
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- Patients under the age of 18
- History of malignant hyperthermia
- Emergency thoracic surgery
- Patients who have not consented to take part in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung Surgery with One-Lung VentilationA single cohort of patients undergoing one-lung ventilation during lung surgery | Procedure or surgery | Lung Surgery with One-Lung Ventilation |
Primary outcome
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
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for One-Lung Ventilation
RecruitingObservational study
Frequency and Severity of Respiratory Acidosis During One-lung Ventilation, a Retrospective Pilot Study to Compare Clinician Settings and Those Proposed by the VentilO Application
Thoracic, Surgery
Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
Recruiting
Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation
Endobronchial Intubation, Double Lumen Tube Intubation
Not yet recruiting
Flow-Controlled Ventilation to Improve Postoperative Pulmonary Outcome After Thoracic Surgery
Mechanical Ventilation, Postoperative Pulmonary Complications (PPCs)
Recruiting
BMI-Adjusted PEEP During One-Lung Ventilation in Thoracic Surgery
Pulmonary Resection Surgery, One Lung Ventillation (OLV)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R P Alston, MBChB,FRCA principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of One-Lung Ventilation, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Blood and End-tidal Isoflurane or Sevoflurane Concentration During One-lung Ventilation (time frame: 10 minutes after start of one-lung ventilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.