Clinical Assessment of the Use of the R8 Respiratory Rate... | NCT01120951

Studies
Clinical Assessment of the Use of the R8 Respiratory Rate Counter in Post-Operative Recovery in Adults and Adolescents

NCT01120951

Sponsor

Anaxsys Technology Ltd

Status

Completed

Last Update Posted

May 18, 2010Estimated

Enrollment

220Actual

Phase

Not provided

Conditions

Respiratory Rate Changes

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

May 9, 2010

First Submission Date that Met QC Criteria

May 9, 2010

First Posted Date

May 11, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2010

Last Update Posted Date

May 18, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study aims to to establish whether or not measurement of respiratory rate taken using the Anaxsys Technology Ltd Respiratory Counter (R8 Counter) are equivalent to manual respiratory rate counting methods in patients receiving oxygen via a face mask.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

220Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female patients aged 12 years and above following elective surgery under general anaesthesia

Exclusion Criteria:

Patients admitted for emergency surgery
Patients having ASA rating of 3 or greater
Patients not receiving general anaesthesia
Patients expected to be in post-operative recovery for less than 15 minutes

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Male or female patients aged 12 years and above following elective surgery under general anaesthesia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Papworth Hospital NHS Foundation Trust		Cambridge	Cambridgeshire	CB23 3RE	United Kingdom
University Hospital of North Staffordshire