NCT02993497

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 15, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

February 5, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2017

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

5 months

First QC Date

December 8, 2016

Last Update Submit

November 9, 2017

Conditions

Prostate CancerBladder Cancer

Outcome Measures

Primary Outcomes (1)

  • The accuracy of breathing measurements

    The accuracy of breathing measurements between infrared camera and RVM in patients with spinal anesthesia

    Intraoperative period about 1 hour

Study Arms (1)

Respiratory monitoring group

EXPERIMENTAL
Device: Infrared cameraDevice: RVM(Respiratory Volume Monitor)

Interventions

Infrared cameraDEVICE

In patients undergoing spinal anesthesia, the respiratory parameters are measured using an Infrared camera.

Respiratory monitoring group
RVM(Respiratory Volume Monitor)DEVICE

In patients undergoing spinal anesthesia, the respiratory parameters are measured using an RVM(Respiratory Volume Monitor).

Also known as: ExSpiron™ 1Xi
Respiratory monitoring group

Eligibility Criteria

Age19 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • An adult male who underwent endoscopic prostatectomy resection with regular surgery
  • An adult male who underwent endoscopic bladder resection with regular surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Prostatic NeoplasmsUrinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesUrologic NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrinary Bladder DiseasesUrologic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2016

First Posted

December 15, 2016

Study Start

February 5, 2017

Primary Completion

July 4, 2017

Study Completion

July 4, 2017

Last Updated

November 14, 2017

Record last verified: 2017-11

Locations

KR(1)