Esophageal Resection Candidates Clinical Trial
— PREPAREOfficial title:
Preoperative Inspiratory Muscle Training to Prevent Postoperative Pneumonia in Patients Undergoing Esophageal Resection
Verified date | May 2017 |
Source | UMC Utrecht |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The PREPARE study is the first multicenter randomized controlled trial to evaluate the hypothesis that preoperative inspiratory muscle training leads to decreased pulmonary complications in patients undergoing esophageal resection.
Status | Completed |
Enrollment | 245 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - (Cognitively) capable to understand and perform a preoperative IMT program - Surgery is scheduled at least 2 weeks after signing informed consent, since the patients need to be able to follow the intervention program for at least 2 weeks - Willing to sign the informed consent form Exclusion Criteria: - Unable to communicate in Dutch language - Age < 18 years - Participating in a conflicting trial concerning esophageal resection |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospital Gasthuisberg | Leuven | |
Finland | HUS | Helsinki | |
Ireland | St. James's Hospital | Dublin | |
Netherlands | Zorggroep Twente | Almelo | |
Netherlands | VU Medical Center | Amsterdam | |
Netherlands | Reinier de Graaf Gasthuis | Delft | |
Netherlands | Atrium Medical Center | Heerlen | |
Netherlands | Canisius Wilhelmina Hospital | Nijmegen | |
Netherlands | UMC Utrecht | Utrecht |
Lead Sponsor | Collaborator |
---|---|
UMC Utrecht |
Belgium, Finland, Ireland, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pneumonia incidence | Pneumonia will be scored according to the Utrecht Pneumonia Scoring System. | Date of first pneumonia event. Participants will be followed for the duration of hospital stay, an expected average of 2 weeks | |
Secondary | Length of stay | Postoperative length of stay on the intensive care unit, Postoperative length of hospital stay. | Time between date of surgery and first discharge from ICU and first discharge from hospital (on average 14 days) | |
Secondary | Duration of mechanical ventilation | Number of hours spent on the mechanical ventilator during and directly following the primary surgery. | Time between intubation and first extubation (in general no more then 24 hours) | |
Secondary | Respiratory muscle function | Inspiratory muscle endurance and maximal inspiratory pressure at the mouth (Pi-max). | At baseline, before surgery and 3, 6 and 9 days after surgery. | |
Secondary | Pulmonary function | Forced Expiratory Volume in one second (FEV1), Forced vital capacity (FVC), FEV1/FVC ratio. | At baseline, before surgery and 3, 6 and 9 days after surgery. | |
Secondary | Quality of life | Quality of life is measured using the EuroQol and SF-12 questionnaires. | At baseline and 4 weeks after surgery |