Does the Incremental Shuttle Walk Test Predict the Development of a Hospital Acquired Pneumonia in Patients Undergoing Elective Oesophagectomy: A Prospective Cohort Study

June 17, 2020 updated by: David McWilliams, University Hospital Birmingham NHS Foundation Trust
The purpose of this study was to assess the predictive value of the incremental shuttle walk test on rates of hospital acquired pneumonia for patients undergoing oesophagectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Field tests to objectively measure functional capacity are becoming of greater importance when looking to assess an individual's fitness for surgery. One such field test is the incremental shuttle walk test (ISWT). An externally paced, maximal excursion test, the ISWT is a simple and easily reproducible test that is widely used within cardiac and pulmonary populations and shown to correlate well with Vo2 mas on a cardiopulmonary exercise test. Previous studies looking at the benefit of the ISWT in predicting post-operative outcomes within the oesophagastric population have demonstrated that walking less than 350 meters has been associated with significantly higher rates of mortality at 30 days and 3 years. No correlation between ISWT and postoperative respiratory complications in this surgical population has been previously reported.

This study aims to assess whether walking <350 meters on an ISWT predicts the development of hospital acquired pneumonias following an elective oesophagectomy

Study Type

Observational

Enrollment (Actual)

121

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B15 2GW
        • UHB NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing oesophagectomy

Description

Inclusion Criteria:

  • Consecutive patients with a diagnosis of oesophagogastric cancer listed for an elective oesophagectomy at a large UK tertiary hospital

Exclusion Criteria:

  • Patients who were unable to complete the walking test
  • patients deemed not fit for surgery
  • patients with a significant neurological event peri or post operatively

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital acquired pneumonia
Time Frame: during hospital stay, on average 14 days
The incidence of hospital acquired pneumonia as defined by the US centres for Disease Control
during hospital stay, on average 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30 day Mortality
Time Frame: 30 days after date of surgery
Mortality rates 30 days post operatively
30 days after date of surgery
90 day Mortality
Time Frame: 90 days following date of surgery
Mortality rates 90 days post operatively
90 days following date of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Birmingham NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2017

Primary Completion (ACTUAL)

February 1, 2020

Study Completion (ACTUAL)

February 1, 2020

Study Registration Dates

First Submitted

June 14, 2020

First Submitted That Met QC Criteria

June 17, 2020

First Posted (ACTUAL)

June 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 19, 2020

Last Update Submitted That Met QC Criteria

June 17, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JW01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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