A Pilot Study of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery

Mayo Clinic1 site in 1 countryJune 2016

ConditionsCancer of Esophagus Cancer of the Esophagus Esophageal Cancer Esophagus Cancer Esophagus Neoplasm Neoplasms, Esophageal

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cancer of Esophagus
Sponsor: Mayo Clinic
Locations: 1
Primary Endpoint: Postoperative Pneumonia
Status: Withdrawn
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To obtain definitive evidence for the effectiveness of a short preoperative inspiratory muscle training (IMT) protocol on the morbidity and recovery from an esophageal surgical resection.

Registry

clinicaltrials.gov

Start Date

June 2016

End Date

June 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Mayo Clinic

Responsible Party

Principal Investigator

Roberto P. Benzo

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

•All patients diagnosed with esophageal cancer and scheduled for esophageal resection at the Mayo Clinic Rochester with gastric conduit reconstruction -Cognitively capable to understand and perform a preoperative program
•Able to follow the intervention program for at least 2 weeks before surgery (surgery is usually scheduled 4 to 12 weeks after radiation)
•Willing to sign the informed consent form

Exclusion Criteria

•Unable to communicate in the English language
•Participating in a conflicting trial concerning esophageal resection

Outcomes

Primary Outcomes

Postoperative Pneumonia

Time Frame: 3 months

To prospectively determine the effect of a customized preoperative inspiratory muscle training (IMT) and brief pulmonary rehabilitation program on the incidence of postoperative pneumonia in patients that undergo an esophageal surgical resection. The investigators will consider the following as pneumonia: new infiltrate + either fever (\>38.5 C) and white cell count \>11,000 or fever and purulent secretions.