NCT04440124

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
Last Updated

June 19, 2020

Status Verified

June 1, 2020

Enrollment Period

2.2 years

First QC Date

June 14, 2020

Last Update Submit

June 17, 2020

Conditions

Keywords

physiotherapyshuttle walk testhospital acquired pneumoniaoutcomesoesophagectomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 30 day Mortality

    30 days after date of surgery

  • 90 day Mortality

    90 days following date of surgery

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing oesophagectomy

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHB NHS Foundation Trust

Birmingham, B15 2GW, United Kingdom

Location

MeSH Terms

Conditions

Esophageal NeoplasmsHealthcare-Associated Pneumonia

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Physiotherapist

Study Record Dates

First Submitted

June 14, 2020

First Posted

June 19, 2020

Study Start

December 1, 2017

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

June 19, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations