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Preoperative Inspiratory Muscle Training in Esophageal Resection (PREPARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01893008
Recruitment Status : Completed
First Posted : July 8, 2013
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
Frank JG Backx, MD PhD, 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.

Condition or disease Intervention/treatment Phase
Esophageal Resection Candidates Other: Inspiratory Muscle Training (IMT) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preoperative Inspiratory Muscle Training to Prevent Postoperative Pneumonia in Patients Undergoing Esophageal Resection
Study Start Date : September 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Usual care + Inspiratory Muscle Training (IMT) Other: Inspiratory Muscle Training (IMT)

The IMT protocol is tailored individually. Inspiratory load is set at 60% of the measured maximal inspiratory pressure (Pimax). The load is incrementally increased based on the rate of perceived exertion (RPE) scored on a scale from 0 to 10 which is scored by the patient after each training session. When patients score an RPE below 7, patients increase the inspiratory load of the threshold device with 5% to guarantee overload during each training session. Patients have to complete 30 dynamic inspiratory efforts twice daily.

Patients will be instructed to train at home 7 days a week until surgery with a minimum of 2 weeks.

Training will be started after the chemoradiation period (if applicable).


No Intervention: Usual care (no IMT)



Primary Outcome Measures :
  1. 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 ]
    Pneumonia will be scored according to the Utrecht Pneumonia Scoring System.


Secondary Outcome Measures :
  1. Length of stay [ Time Frame: 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.

  2. Duration of mechanical ventilation [ Time Frame: 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.

  3. Respiratory muscle function [ Time Frame: At baseline, before surgery and 3, 6 and 9 days after surgery. ]
    Inspiratory muscle endurance and maximal inspiratory pressure at the mouth (Pi-max).

  4. Pulmonary function [ Time Frame: 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.

  5. Quality of life [ Time Frame: At baseline and 4 weeks after surgery ]
    Quality of life is measured using the EuroQol and SF-12 questionnaires.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893008


Locations
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Belgium
University Hospital Gasthuisberg
Leuven, Belgium
Finland
HUS
Helsinki, Finland
Ireland
St. James's Hospital
Dublin, Ireland
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, Netherlands
Sponsors and Collaborators
UMC Utrecht

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Frank JG Backx, MD PhD, Professor in Clinical Sports Medicine, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01893008     History of Changes
Other Study ID Numbers: NL43194.041.13
First Posted: July 8, 2013    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017
Keywords provided by Frank JG Backx, MD PhD, UMC Utrecht:
Esophageal cancer
Surgery
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes