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

Sponsor
Anaxsys Technology Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT01120951
Collaborator
(none)
220
Enrollment
4
Locations
3
Duration (Months)
55
Patients Per Site
18.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    220 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Clinical Assessment of the Use of the R8 Respiratory Rate Counter in Post-Operative Recovery in Adults and Adolescents
    Study Start Date :
    Jan 1, 2010
    Actual Primary Completion Date :
    Apr 1, 2010
    Actual Study Completion Date :
    Apr 1, 2010

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      12 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Papworth Hospital NHS Foundation Trust Cambridge Cambridgeshire United Kingdom CB23 3RE
      2 University Hospital of North Staffordshire Stoke-on-Trent Staffordshire United Kingdom ST4 6QG
      3 St. Peter's and Ashford Hospital NHS Trust Guildford Surrey United Kingdom KT16 0PZ
      4 Russells Hall Hospital Dudley West Midlands United Kingdom DY1 2HQ

      Sponsors and Collaborators

      • Anaxsys Technology Ltd

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01120951
      Other Study ID Numbers:
      • ATL01009
      First Posted:
      May 11, 2010
      Last Update Posted:
      May 18, 2010
      Last Verified:
      May 1, 2010
      Keywords provided by , ,
      Respiratory rate R8 Anaxsys

      Study Results

      No Results Posted as of May 18, 2010