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NCT Number: NCT01893008

Preoperative Inspiratory Muscle Training in Esophageal Resection

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.

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Key information

Conditions

Esophageal Resection Candidates Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Gasthuisberg, Leuven, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inspiratory muscle training (IMT)

Other

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).

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Official study title

Preoperative Inspiratory Muscle Training to Prevent Postoperative Pneumonia in Patients Undergoing Esophageal Resection

Acronym: PREPARE

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 8, 2013
Registry last updated
May 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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