Contact information
Type
Scientific
Primary contact
Dr H.J. Hulzebos
ORCID ID
Contact details
University Medical Center Utrecht
Huispost STR 5.203
P.O. Box 85500
Amsterdam
3508 GA
Netherlands
+31 (0)30 253 8484
H.Hulzebos@pmbr.azu.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ZonMw reference 1310.0004
Study information
Scientific title
Acronym
PORT
Study hypothesis
Preoperative physiotherapy decreased the incidence of postoperative pulmonary complications (PPCs) after open heart surgery on patients with an increased risk of developing PPCs.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Multicentre, randomised, single blind, active controlled, factorial group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Postoperative pulmonary complications
Intervention
The preoperative physiotherapy consists of a combination of respiratory exercises involving the costo-diaphragm breathing technique, training of the inspiratory muscles for strength and endurance, and teaching a good technique for coughing and 'forced expiration techniques'. The method, involving a progressive training course, is initiated four weeks before the operation.
The training period and progress of the training are sufficient to improve the strength and endurance of the respiratory musculature (also: accessory respiratory muscles). Neuromuscular changes are especially important to increase the efficiency of breathing by the OHS patient. Exercise periods lasting 20 minutes are conducted once per day seven days each week. The therapy is continued by the patient at home, once per week under the supervision of a physiotherapist and six times per week alone. During the supervised training at the beginning and at the end of the period of application, the heart rate and the blood pressure are measured to determine the cardiovascular stress.
In addition the patient keeps a diary, in which he notes the number of exercise sessions completed per week, the duration of each session, and the subjectively experienced stress. In the diary, space is provided for notes regarding physical complaints and problems that occurred before, during or after the exercises.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Postoperative pulmonary complications (PPCs) are defined as 'any pulmonary abnormality occurring in the postoperative period that produces identifiable diseases or dysfunctions that are clinically significant and adversely affect clinical developments' (Brooks-Brunn, 1995). In this study, PPCs are explicitly classified and treated according to the criteria of Kroenke et. al.
Secondary outcome measures
Length of hospital stay.
Overall trial start date
24/06/2002
Overall trial end date
01/10/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Undergo voluntary coronary artery bypass graft (CABG) surgery
2. Have an increased risk of developing a PPC. High risk for the development of PPCs is determined by using the risk model during the preoperative consultation with the anaesthesiologist (6 - 8 weeks before the operation)
3. Understand Dutch language
4. Able to read
5. Capable of passing a spirometer test and a determination of the mouth pressure
6. Prepared to sign a contract of informed consent
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
600
Participant exclusion criteria
1. Cerebrovascular illnesses
2. Immunosuppressive treatment less than 30 days before the operation (chemotherapy or radiotherapy)
3. Neuromuscular illnesses (among others Guillein Barre, muscular dystrophy, myasthenia gravis)
4. A previous lung operation
5. Cardiovascular instability
6. The presence of aneurisms
7. Lung physiotherapy less than eight weeks before the operation
8. Postoperative cardiac and/or complications involving the central nervous system
Recruitment start date
24/06/2002
Recruitment end date
01/10/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Utrecht
Amsterdam
3508 GA
Netherlands
Sponsor information
Organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Sponsor details
P.O. Box 93245
Den Haag
2509 AE
Netherlands
+31 (0)70 349 5111
info@zonmw.nl
Sponsor type
Research organisation
Website
Funders
Funder type
University/education
Funder name
University Medical Center Utrecht (UMCU) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in:
1. http://www.ncbi.nlm.nih.gov/pubmed/17047215
2. http://www.ncbi.nlm.nih.gov/pubmed/18062595
Publication citations
-
Hulzebos EH, Helders PJ, Favié NJ, De Bie RA, Brutel de la Riviere A, Van Meeteren NL, Preoperative intensive inspiratory muscle training to prevent postoperative pulmonary complications in high-risk patients undergoing CABG surgery: a randomized clinical trial., JAMA, 2006, 296, 15, 1851-1857, doi: 10.1001/jama.296.15.1851.
-
Hulzebos EH, Helders PJ, Favié NJ, de Bie RA, Brutel de la Rivière A, van Meeteren NL, [Fewer lung complications following inspiratory muscle training in patients undergoing coronary bypass surgery: a randomized trial]., Ned Tijdschr Geneeskd, 2007, 151, 45, 2505-2511.