Preoperative Inspiratory Muscle Training in Esophageal Resection (PREPARE)

UMC Utrecht

Status: Completed

Conditions: Esophageal Resection Candidates

Treatments: Other: Inspiratory Muscle Training (IMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT01893008

NL43194.041.13

Details and patient eligibility

About

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.

Full description

Rationale: Esophageal resection is associated with high incidences of postoperative pulmonary pneumonia. Numbers of 30% are reported in literature. Postoperative complications can result in prolonged hospital stay and increased health care costs. In cardiac surgery patients a reduction of postoperative pneumonia of 50% is reported as a result of a preoperative inspiratory muscle training program. While in some surgical centers IMT is already used in the preoperative phase in patients undergoing esophageal resection, the effect of this promising intervention has not yet been investigated in a randomised and controlled study design in large surgical populations other than cardiac surgery.

Primary objective: Investigate the effect of a preoperative inspiratory muscle training program on the incidence of postoperative pneumonia in patients undergoing esophageal resection.

Study design: Prospective multicenter randomised controlled clinical trial.

Main study parameters/endpoints: A significant reduction in incidence of postoperative pneumonia.

Enrollment: 245 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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245 participants in 2 patient groups

Usual care + Inspiratory Muscle Training (IMT)

Experimental group

Treatment:

Other: Inspiratory Muscle Training (IMT)

Usual care (no IMT)

No Intervention group