Preoperative Inspiratory Muscle Training in Esophageal Resection

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01893008
• Date of registration: 17/06/2013
• Prospective Registration: Yes
• Primary sponsor: UMC Utrecht
• Public title: Preoperative Inspiratory Muscle Training in Esophageal Resection PREPARE
• Scientific title: Preoperative Inspiratory Muscle Training to Prevent Postoperative Pneumonia in Patients Undergoing Esophageal Resection
• Date of first enrolment: September 2013
• Target sample size: 245
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01893008
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Belgium, Finland, Ireland, Netherlands

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Esophageal Resection Candidates

Intervention(s)

Other: Inspiratory Muscle Training (IMT)

Primary Outcome(s)

Pneumonia incidence [Time Frame: Date of first pneumonia event. Participants will be followed for the duration of hospital stay, an expected average of 2 weeks]

Secondary Outcome(s)

Duration of mechanical ventilation [Time Frame: Time between intubation and first extubation (in general no more then 24 hours)]

Respiratory muscle function [Time Frame: At baseline, before surgery and 3, 6 and 9 days after surgery.]

Length of stay [Time Frame: Time between date of surgery and first discharge from ICU and first discharge from hospital (on average 14 days)]

Quality of life [Time Frame: At baseline and 4 weeks after surgery]

Pulmonary function [Time Frame: At baseline, before surgery and 3, 6 and 9 days after surgery.]

Secondary ID(s)

NL43194.041.13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors