NCT Number: NCT03394222
Effect of Preoperative Budesonide Inhalation on Arterial Blood Oxygenation and Intrapulmonary Shunt During OLV
The purpose of this study is to conduct a randomized controlled trial to evaluate the effect of preoperative budesonide inhalation on arterial blood oxygenation and intrapulmonary shunt in patients received one-lung ventilation
Looking for future studies?
Notify MeKey information
Conditions
Age range
45 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
About this study
Population:
The target population comprises all adult aged 45-65 years who was diagnosed lung cancer and to receive video-assist thoracoscopic lobectomy under general anethesia.The study sample will include 50 subjects of both gender and any race or ethnicity.
Procedures:
Eligible and consented patients will be enrolled into the study if all eligibility criteria are met and will be randomly allocated to one of the two study arms:Budesonide inhalation group vs Normal saline inhalation group
Study Duration:
Overall duration of the study is 10 months.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Aged 45 yr to 65 yr ,height 155-176cm,weight 45-75kg,body mass index(BMI)18-27kg/m2,ASA Physical Status Classifications I to II,left-lateral position during OLV ,normal cardiac and pulmonary function ,and no cardiac,hepatic,renal and endocrine diseases.Diagnosed with uncomplicated lung cancer and was to receive video-assist thoracoscopic lobectomy under general anesthesia.
Exclusion criteria
- FEV1/FVC<70%,asthma,chronic obstructive pulmonary disease,acute lung infection,past history of thoracic surgery. preoperative glucocorticoid medication,preoperative chemotherapy,SpO2 kept below 90% for more than 15 minutes during operation,blood transfusion during operation,OLV less than an hour,occurrence of severe complications like allergic shock.
Treatment and study plan
preoperative normal saline inhalation
DrugPrimary outcomes
-
Arterial blood oxygenation
Time frame: Arterial blood oxygenation was assessed through blood gas analysis before intervention,before OLV ,10 min after OLV,30 min after OLV,60 min after OLV and 10min after two-lung ventilation.
Arterial blood oxygenation was assessed through blood gas analysis of sample taken from radial artery
Secondary outcomes
-
Intrapulmonary shunt
Time frame: Intrapulmonary shunt was assessed through blood gas analysis before intervention,before OLV ,10 min after OLV,30 min after OLV,60 min after OLV and 10min after two-lung ventilation
Intrapulmonary shunt was assessed through blood gas analysis of sample taken
Sponsors and collaborators
Lead sponsor
Fujian Medical University Union Hospital
Other
Registry information
Official study title
Effect of Preoperative Budesonide Inhalation on Arterial Blood Oxygenation and Intrapulmonary Shunt in Patients Received One-lung Ventilation
Important dates
- Study start
- 2016
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Jan 9, 2018
- Registry last updated
- Jan 9, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Development of a Biologic Specimen Bank for the Study of Early Markers of Lung Cancer Among Tin Miners in Yunnan, China
NCT00340405
Lung Cancer, Lung Diseases
Beijing, China
View Trial DetailsModulation of Anti-tumor T Cell Responses in Cancer Patients Treated by Concomitant Radiochemotherapy
NCT03117946
Head and Neck Cancer, Head and Neck Neoplasms
Besançon, France
View Trial DetailsIncreasing Adherence to Lung Cancer Screening
NCT05832008
Adherence, Patient, Behavior
Philadelphia, Pennsylvania, United States
View Trial DetailsAssessment of Diagnostic Yield Using a Robotic Navigational Bronchoscopy System With CBCT
NCT06084208
Lung Cancer, Lung Diseases
Nijmegen, Netherlands
View Trial Details