Back to resultsRespiratory Measurement Using Infrared Camera and Respiratory Volume Monitor (ExSpiron 1Xi) for Sedation in Patients Undergoing TURP/TURB Under Spinal Anesthesia
Primary Purpose
Prostate Cancer, Bladder Cancer
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Infrared camera
RVM(Respiratory Volume Monitor)
Sponsored by
About this trial
This is an interventional supportive care trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- An adult male who underwent endoscopic prostatectomy resection with regular surgery
- An adult male who underwent endoscopic bladder resection with regular surgery
Exclusion Criteria:
- Presenting alteration in respiratory function detected by functional analysis of lung volume and capacity- pneumonectomy patient, severe ipsilateral destroyed lung patient
- Inability to understand or perform the procedure
- ASA(American Society of Anesthesiologists) class 4,5
Sites / Locations
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Respiratory monitoring group
Arm Description
Outcomes
Primary Outcome Measures
The accuracy of breathing measurements
The accuracy of breathing measurements between infrared camera and RVM in patients with spinal anesthesia
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02993497
Brief Title
Respiratory Measurement Using Infrared Camera and Respiratory Volume Monitor (ExSpiron 1Xi) for Sedation in Patients Undergoing TURP/TURB Under Spinal Anesthesia
Official Title
Respiratory Measurement Using Infrared Camera and Respiratory Volume Monitor (ExSpiron 1Xi) for Sedation in Patients Undergoing TURP/TURB Under Spinal Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
February 5, 2017 (Actual)
Primary Completion Date
July 4, 2017 (Actual)
Study Completion Date
July 4, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In patients undergoing spinal anesthesia, the investigators used an Infra-red camera and a respiratory volume monitor to determine the accuracy of the ventilation rate of the infra red camera by measuring the respiratory rate, ventilation volume, and ventilation volume with respiratory volume monitor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Bladder Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Respiratory monitoring group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Infrared camera
Intervention Description
In patients undergoing spinal anesthesia, the respiratory parameters are measured using an Infrared camera.
Intervention Type
Device
Intervention Name(s)
RVM(Respiratory Volume Monitor)
Other Intervention Name(s)
ExSpiron™ 1Xi
Intervention Description
In patients undergoing spinal anesthesia, the respiratory parameters are measured using an RVM(Respiratory Volume Monitor).
Primary Outcome Measure Information:
Title
The accuracy of breathing measurements
Description
The accuracy of breathing measurements between infrared camera and RVM in patients with spinal anesthesia
Time Frame
Intraoperative period about 1 hour
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
An adult male who underwent endoscopic prostatectomy resection with regular surgery
An adult male who underwent endoscopic bladder resection with regular surgery
Exclusion Criteria:
Presenting alteration in respiratory function detected by functional analysis of lung volume and capacity- pneumonectomy patient, severe ipsilateral destroyed lung patient
Inability to understand or perform the procedure
ASA(American Society of Anesthesiologists) class 4,5
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Respiratory Measurement Using Infrared Camera and Respiratory Volume Monitor (ExSpiron 1Xi) for Sedation in Patients Undergoing TURP/TURB Under Spinal Anesthesia
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