Preoperative Inspiratory Muscle Training in Esophageal Resection

Esophageal Resection Candidates Clinical Trial

— PREPARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01893008
• Other study ID #: NL43194.041.13
• Status: Completed
• Phase: N/A
• First received: June 17, 2013
• Last updated: May 10, 2017
• Start date: September 2013
• Est. completion date: July 2016

Study information

• Verified date: May 2017
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Resection Candidates

Intervention

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).

Locations

Country	Name	City	State
Belgium	University Hospital Gasthuisberg	Leuven
Finland	HUS	Helsinki
Ireland	St. James's Hospital	Dublin
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

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Countries where clinical trial is conducted

Belgium,  Finland,  Ireland,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pneumonia incidence	Pneumonia will be scored according to the Utrecht Pneumonia Scoring System.	Date of first pneumonia event. Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary	Length of stay	Postoperative length of stay on the intensive care unit, Postoperative length of hospital stay.	Time between date of surgery and first discharge from ICU and first discharge from hospital (on average 14 days)
Secondary	Duration of mechanical ventilation	Number of hours spent on the mechanical ventilator during and directly following the primary surgery.	Time between intubation and first extubation (in general no more then 24 hours)
Secondary	Respiratory muscle function	Inspiratory muscle endurance and maximal inspiratory pressure at the mouth (Pi-max).	At baseline, before surgery and 3, 6 and 9 days after surgery.
Secondary	Pulmonary function	Forced Expiratory Volume in one second (FEV1), Forced vital capacity (FVC), FEV1/FVC ratio.	At baseline, before surgery and 3, 6 and 9 days after surgery.
Secondary	Quality of life	Quality of life is measured using the EuroQol and SF-12 questionnaires.	At baseline and 4 weeks after surgery