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Completed

NCT Number: NCT04440124

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

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.

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Key information

Conditions

Oesophageal Cancer Cross Infection Digestive System Diseases Digestive System Neoplasms Disease Attributes Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UHB NHS Foundation Trust

Birmingham, B15 2GW, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Incremental shuttle walk test

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 30 day Mortality

    Time frame: 30 days after date of surgery

    Mortality rates 30 days post operatively

  2. 90 day Mortality

    Time frame: 90 days following date of surgery

    Mortality rates 90 days post operatively

Sponsors and collaborators

Lead sponsor

University Hospital Birmingham NHS Foundation Trust

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 19, 2020
Registry last updated
Jun 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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