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

NCT02821455 | Completed Results

• 1 other identifier: AC16081
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

One-Lung Ventilation

Keywords

Isoflurane; Sevoflurane; Bispectral Index; Pulmonary Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation Between Bispectral Index (BIS) and End-tidal Isoflurane or Sevoflurane Concentration During One-lung Ventilation.

  10 minutes after start of one-lung ventilation

Study Arms (1)

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

Interventions

Lung Surgery with One-Lung Ventilation PROCEDURE

A single cohort of patients undergoing one-lung ventilation during lung surgery

Lung Surgery with One-Lung Ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Patients under the age of 18
• History of malignant hyperthermia
• Emergency thoracic surgery
• Patients who have not consented to take part in the study

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

2 10mL whole blood samples per patient

MeSH Terms

Interventions

Pulmonary Surgical Procedures; One-Lung Ventilation

Intervention Hierarchy (Ancestors)

Thoracic Surgical Procedures; Surgical Procedures, Operative; Respiration, Artificial; Airway Management; Therapeutics

Results Point of Contact

• Title: E Alexandra Page
• Organization: University of Edinburgh

s1305565@sms.ed.ac.uk

7938645122

Study Officials

• R P Alston, MBChB,FRCA

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 1, 2016
• Study Start: August 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: January 1, 2017
• Last Updated: August 2, 2018
• Results First Posted: August 2, 2018

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)