Esophageal Resection CandidatesPREPARENCT01893008
Preoperative Inspiratory Muscle Training in Esophageal Resection
A study testing Inspiratory Muscle Training (IMT) in people with Esophageal Resection Candidates, run by UMC Utrecht at 9 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Resection Candidates
- What is being tested?
- Inspiratory Muscle Training (IMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 9 sitesin 4 countries
- Study dates
- Sep 2013to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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
Who cannot join
- Unable to communicate in Dutch language
- Age < 18 years
- Participating in a conflicting trial concerning esophageal resection
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Netherlands6 sites
Zorggroep Twente
Almelo
VU Medical Center
Amsterdam
Reinier de Graaf Gasthuis
Delft
Atrium Medical Center
Heerlen
Canisius Wilhelmina Hospital
Nijmegen
UMC Utrecht
Utrecht
About this study
Official title: Preoperative Inspiratory Muscle Training to Prevent Postoperative Pneumonia in Patients Undergoing 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.
Read the 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.
- Conditions
- Esophageal Resection Candidates
- Being tested
- Inspiratory Muscle Training (IMT)
- Keywords
- Esophageal cancer, Surgery
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Usual care + Inspiratory Muscle Training (IMT) | Experimental | Not described Receives: Other: Inspiratory Muscle Training (IMT) |
| Usual care (no IMT) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumonia incidence
Pneumonia will be scored according to the Utrecht Pneumonia Scoring System.
Measured: Date of first pneumonia event. Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes (5)
Length of stay
Postoperative length of stay on the intensive care unit, Postoperative length of hospital stay.
Measured: Time between date of surgery and first discharge from ICU and first discharge from hospital (on average 14 days)
Duration of mechanical ventilation
Number of hours spent on the mechanical ventilator during and directly following the primary surgery.
Measured: Time between intubation and first extubation (in general no more then 24 hours)
Respiratory muscle function
Inspiratory muscle endurance and maximal inspiratory pressure at the mouth (Pi-max).
Measured: At baseline, before surgery and 3, 6 and 9 days after surgery.
Pulmonary function
Forced Expiratory Volume in one second (FEV1), Forced vital capacity (FVC), FEV1/FVC ratio.
Measured: At baseline, before surgery and 3, 6 and 9 days after surgery.
Quality of life
Quality of life is measured using the EuroQol and SF-12 questionnaires.
Measured: At baseline and 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Esophageal Resection CandidatesStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank JG Backx, MD PhD, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893008
- Sponsor's protocol ID
- NL43194.041.13
- Acronym
- PREPARE
- Status last verified
- May 2017
- First submitted
- 17 Jun 2013
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Valkenet K, Trappenburg JCA, Ruurda JP, Guinan EM, Reynolds JV, Nafteux P, Fontaine M, Rodrigo HE, van der Peet DL, Hania SW, Sosef MN, Willms J, Rosman C, Pieters H, Scheepers JJG, Faber T, Kouwenhoven EA, Tinselboer M, Rasanen J, Ryynanen H, Gosselink R, van Hillegersberg R, Backx FJG. Multicentre randomized clinical trial of inspiratory muscle training versus usual care before surgery for oesophageal cancer. Br J Surg. 2018 Apr;105(5):502-511. doi: 10.1002/bjs.10803.
PubMed 29603130Valkenet K, Trappenburg JC, Gosselink R, Sosef MN, Willms J, Rosman C, Pieters H, Scheepers JJ, de Heus SC, Reynolds JV, Guinan E, Ruurda JP, Rodrigo EH, Nafteux P, Fontaine M, Kouwenhoven EA, Kerkemeyer M, van der Peet DL, Hania SW, van Hillegersberg R, Backx FJ. Preoperative inspiratory muscle training to prevent postoperative pulmonary complications in patients undergoing esophageal resection (PREPARE study): study protocol for a randomized controlled trial. Trials. 2014 Apr 27;15:144. doi: 10.1186/1745-6215-15-144.
PubMed 24767575
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Inspiratory Muscle Training to Prevent Postoperative Pneumonia in Patients Undergoing Esophageal Resection
- ClinicalTrials.gov ID
- NCT01893008
- Acronym / sponsor ID
- PREPARE / NL43194.041.13
- Conditions
- Esophageal Resection Candidates
- Keywords
- Esophageal cancer, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 8 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care + Inspiratory Muscle Training (IMT) | Experimental | Other: Inspiratory Muscle Training (IMT) |
| Usual care (no IMT) | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- (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
Key exclusion criteria (3 listed)
- Unable to communicate in Dutch language
- Age < 18 years
- Participating in a conflicting trial concerning esophageal resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | Usual care + Inspiratory Muscle Training (IMT) |
Primary outcome
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.
5 secondary outcomes
Length of stay
Time frame: Time between date of surgery and first discharge from ICU and first discharge from hospital (on average 14 days)
Duration of mechanical ventilation
Time frame: Time between intubation and first extubation (in general no more then 24 hours)
Respiratory muscle function
Time frame: At baseline, before surgery and 3, 6 and 9 days after surgery.
Pulmonary function
Time frame: At baseline, before surgery and 3, 6 and 9 days after surgery.
Quality of life
Time frame: At baseline and 4 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Derived from this study: PubMed 29603130Valkenet K, Trappenburg JCA, Ruurda JP, Guinan EM, Reynolds JV, Nafteux P, Fontaine M, Rodrigo HE, van der Peet DL, Hania SW, Sosef MN, Willms J, Rosman C, Pieters H, Scheepers JJG, Faber T, Kouwenhoven EA, Tinselboer M, Rasanen J, Ryynanen H, Gosselink R, van Hillegersberg R, Backx FJG. Multicentre randomized clinical trial of inspiratory muscle training versus usual care before surgery for oesophageal cancer. Br J Surg. 2018 Apr;105(5):502-511. doi: 10.1002/bjs.10803.
- Derived from this study: PubMed 24767575Valkenet K, Trappenburg JC, Gosselink R, Sosef MN, Willms J, Rosman C, Pieters H, Scheepers JJ, de Heus SC, Reynolds JV, Guinan E, Ruurda JP, Rodrigo EH, Nafteux P, Fontaine M, Kouwenhoven EA, Kerkemeyer M, van der Peet DL, Hania SW, van Hillegersberg R, Backx FJ. Preoperative inspiratory muscle training to prevent postoperative pulmonary complications in patients undergoing esophageal resection (PREPARE study): study protocol for a randomized controlled trial. Trials. 2014 Apr 27;15:144. doi: 10.1186/1745-6215-15-144.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training (IMT) in people with Esophageal Resection Candidates, run by UMC Utrecht at 9 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Netherlands, Belgium, Finland, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01893008, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.