One-Lung Ventilation Clinical Trial
Official title:
A Comparison of Oxygen Saturation Between Lateral Decubitus Lung Surgery and Port Access Procedures in Dorsal Decubitus
Verified date | October 2014 |
Source | Onze Lieve Vrouw Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Belgium: Ethics Committee |
Study type | Interventional |
One-lung ventilation (OLV) during thoracic surgery and its effect on oxygen saturation has
been discussed in multiple studies. Literature shows different ventilation strategies and
possible hypoxemia has been attributed to several issues.
Port-access cardiac surgical procedures ("key hole surgery" including mitral valve repair or
prosthesis, tricuspid valve repair or prosthesis, atrial septal defect closure or a
combination of these) require the use of OLV as well. Its effect on oxygen saturation has
not been studied previously.
The aim of this study is to investigate the effect of extracorporeal circulation (ECC) and
patient positioning on oxygen saturation and on the progress of hypoxemia throughout OLV
during port-access in comparison to oxygen saturation throughout OLV during lateral
decubitus thoracotomies.
Status | Terminated |
Enrollment | 29 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Patients undergoing lateral decubitus lung surgery or port-access. - American Society of Anesthesiologists Physical Status (ASA) II or III. - Age between 18-80 years. - Patients willing to sign consent. Exclusion Criteria: - Pre-existing interstitial lung disease. - Pre-existing obstructive airway disease. - Inability or unwillingness of study participant to give written informed consent. - Patients expected to have a difficult intubation for anatomical reasons. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | OLV Hospital | Aalst |
Lead Sponsor | Collaborator |
---|---|
Onze Lieve Vrouw Hospital |
Belgium,
Karzai W, Schwarzkopf K. Hypoxemia during one-lung ventilation: prediction, prevention, and treatment. Anesthesiology. 2009 Jun;110(6):1402-11. doi: 10.1097/ALN.0b013e31819fb15d. Review. — View Citation
Watanabe S, Noguchi E, Yamada S, Hamada N, Kano T. Sequential changes of arterial oxygen tension in the supine position during one-lung ventilation. Anesth Analg. 2000 Jan;90(1):28-34. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | oxygen saturation | To assess if more interventions are needed to maintain oxygenation during one-lung ventilation in port-access procedures compared with the non-cardiac surgical procedures under one lung ventilation in lateral decubitus | each 15 min once one-lung ventilation is initiated | Yes |
Primary | oxygen saturation | To compare oxygen saturation during one-lung ventilation in patients undergoing lateral decubitus for non-cardiac thoracic surgery, requiring more than 20 minutes of one-lung ventilation using double lumen intubation, versus patients undergoing port-access cardiac surgical procedures. | 20 minutes after initiation of one-lung ventilation | Yes |
Secondary | oxygen saturation | To assess if oxygen saturation during one-lung ventilation depends on patient positioning. | 15 minutes of one-lung ventilation after patient positioning | Yes |
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