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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04440124
Other study ID # JW01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2017
Est. completion date February 1, 2020

Study information

Verified date June 2020
Source University Hospital Birmingham NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Completed
Enrollment 121
Est. completion date February 1, 2020
Est. primary completion date February 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Incremental shuttle walk test
All patients were reviewed by a physiotherapist during their pre-assessment clinic one week prior to surgery to complete an incremental shuttle walk test (ISWT). The ISWT was completed according to a standardised protocol and involved patients walking around 2 cones set up 9 metres apart. Patients were asked to cover the distance between the cones in time to auditory cues. Oxygen levels and heart rate were recorded during the assessment with the use of a portable pulse oximeter. The test was stopped when patients could no longer keep pace with the auditory cues or were too breathless to continue. The total distance mobilised was recorded.

Locations

Country Name City State
United Kingdom UHB NHS Foundation Trust Birmingham

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Birmingham NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hospital acquired pneumonia The incidence of hospital acquired pneumonia as defined by the US centres for Disease Control during hospital stay, on average 14 days
Secondary 30 day Mortality Mortality rates 30 days post operatively 30 days after date of surgery
Secondary 90 day Mortality Mortality rates 90 days post operatively 90 days following date of surgery
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