Inspiratory Strength and Respiratory Complications After SCI Injury (RESCOM)
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|ClinicalTrials.gov Identifier: NCT02891096|
Recruitment Status : Recruiting
First Posted : September 7, 2016
Last Update Posted : July 11, 2019
|Condition or disease||Intervention/treatment|
|Spinal Cord Injuries Pneumonia||Procedure: inspiratory muscle strength|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Inspiratory Muscle Strength and Respiratory Complications After Spinal Cord Injury: a Multicenter, Prospective Cohort Study|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
- Procedure: inspiratory muscle strength
- in- and expiratory muscle strength (5min)
- lung function (FVC, FEV1, PEF, PCF) (10 min)
- ISCoS core data-set
- ISCoS pulmonary function data sets
- ISCoS quality of life questionnaire
- questionnaire on individual respiratory muscle training, regular physical exercise and therapies
- individual medication/vaccination and other medical complications will be assessed from patient's medical records
All measurements will be performed at each of the 4 measurement time-points (up to 4 times during inpatient rehabilitation) and last about 40 min per patient and measurement time-point in total (time with patient).
- Inspiratory muscle strength in relation to pneumonia [ Time Frame: in days post injury: T1:28±12; T2:84±14, T3:150±18; T4:15 days before discharge until discharge ]
Inspiratory muscle strength will be measured using a hand-held respiratory pressure meter (Micro RPM, Micro Medical, Hoechberg, Germany) by an independent study nurse of each participating study site. All measurements will be performed with the patients sitting upright in their own wheelchair.
Patients have to breathe through a mouthpiece while wearing a nose clip. Each measurement will be repeated three times. The greatest value of each parameter will be used for analysis.
- Lung function measurements [ Time Frame: in days post injury: T1:28±12; T2:84±14, T3:150±18; T4:15 days before discharge until discharge ]
The various lung parameters thus include maximum expiratory pressure (MEP), vital capacity (FVC), forced expiratory volume in 1 second (FEV1), peak expiratory flow (PEF) and peak cough flow (PCF).
The measurement of the respiratory muscle strength and lung function will be conducted in sitting position in the own wheelchair or for pedestrians on a chair and lasts at most 15 minutes. The measurements will be conducted with a device for respiratory pressure measurement in which the patient has to inhale and exhale through a mouthpiece. Each measurement of the inspiration and expiration will be repeated 3 times per measurement time.
The peak cough flow (PCF) will be measured by having the person cough as forcefully as possible through a peak flow meter.
The greatest value of each lung function parameter will be used for analysis.
- Mortality due to pneumonia [ Time Frame: in days post injury: T1:28±12; T2:84±14, T3:150±18; T4:15 days before discharge until discharge ]Mortality will be defined as pneumonia-related, if a prevailing event of pneumonia was clinically resolved as the initiating factor of the cascade of morbid events leading directly to death. Similarly, other causes of death will be recorded as part of all-cause mortality and as potentially competing risks of death.
- Quality of life in general [ Time Frame: in days post injury: T1:28±12; T2:84±14, T3:150±18; T4:15 days before discharge until discharge ]Quality of life (Qol) will be evaluated using the Quality of Life Basic Data Set of the International Spinal Cord Injury Datasets. This measurement instrument accepts (Qol) as a multi-facetted concept and includes three questions as to capture general quality of life (overall well-being), rating of physical health, and satisfaction with psychological health.
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): NCT02891096
|Contact: Gabi Mueller, PhD||+41 (0) 41 939 firstname.lastname@example.org|
|Contact: Anja M Raab, MSc||+41 (0) 41 939 email@example.com|
|Swiss Paraplegic Centre Nottwil||Recruiting|
|Nottwil, Lucerne, Switzerland, 6207|
|Contact: Gabi Mueller, PhD +41 (0) 41 939 5563 firstname.lastname@example.org|
|Contact: Anja M Raab, MSc +41 (0) 41 939 5966 email@example.com|
|Principal Investigator: Gabi Mueller, PhD|
|Principal Investigator:||Gabi Mueller, PhD||Swiss Paraplegic Centre Nottwil, Clinical Trial Unit|