Preoperative Inspiratory Muscle Training in Esophageal Resection

Not Applicable

Completed

• Conditions: Esophageal Resection Candidates
• Interventions: Other: Inspiratory Muscle Training (IMT)

• Registration Number: NCT01893008
• Lead Sponsor: UMC Utrecht

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-06-17
• Study First Submitted QC: 2013-07-01
• Study First Posted: 2013-07-08
• Study Start: 2013-09
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-10
• Last Update Posted: 2017-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care + Inspiratory Muscle Training (IMT)	Inspiratory Muscle Training (IMT)	-

Primary Outcome Measures

Name	Time	Method
Pneumonia incidence	Date of first pneumonia event. Participants will be followed for the duration of hospital stay, an expected average of 2 weeks	Pneumonia will be scored according to the Utrecht Pneumonia Scoring System.

Secondary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation	Time between intubation and first extubation (in general no more then 24 hours)	Number of hours spent on the mechanical ventilator during and directly following the primary surgery.
Length of stay	Time between date of surgery and first discharge from ICU and first discharge from hospital (on average 14 days)	Postoperative length of stay on the intensive care unit, Postoperative length of hospital stay.
Respiratory muscle function	At baseline, before surgery and 3, 6 and 9 days after surgery.	Inspiratory muscle endurance and maximal inspiratory pressure at the mouth (Pi-max).
Pulmonary function	At baseline, before surgery and 3, 6 and 9 days after surgery.	Forced Expiratory Volume in one second (FEV1), Forced vital capacity (FVC), FEV1/FVC ratio.
Quality of life	At baseline and 4 weeks after surgery	Quality of life is measured using the EuroQol and SF-12 questionnaires.

Trial Locations

Locations (9)

Canisius Wilhelmina Hospital; 🇳🇱 Nijmegen, Netherlands

St. James's Hospital; 🇮🇪 Dublin, Ireland

VU Medical Center; 🇳🇱 Amsterdam, Netherlands

Atrium Medical Center; 🇳🇱 Heerlen, Netherlands

University Hospital Gasthuisberg; 🇧🇪 Leuven, Belgium

Zorggroep Twente; 🇳🇱 Almelo, Netherlands

UMC Utrecht; 🇳🇱 Utrecht, Netherlands

HUS; 🇫🇮 Helsinki, Finland

Reinier de Graaf Gasthuis; 🇳🇱 Delft, Netherlands