Trial Outcomes & Findings for Inspiratory Strength and Respiratory Complications After SCI Injury (NCT NCT02891096)

Results Overview

occurrence of pneumonia

Recruitment status

COMPLETED

Target enrollment

550 participants

Primary outcome timeframe

From date of spinal cord injury until discharge from primary rehabilitation (i.e. individual time window of observation from a few weeks to about 1 year)

Results posted on

2025-02-24

Participant Flow

4 participants had to be excluded before start

Participant milestones

Participant milestones
Measure	Inpatient Rehab all new SCI in inpatient rehabilitation
Overall Study STARTED	546
Overall Study COMPLETED	503
Overall Study NOT COMPLETED	43

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Inpatient Rehab n=503 Participants all new SCI in inpatient rehabilitation
Age, Categorical <=18 years	0 Participants n=503 Participants
Age, Categorical Between 18 and 65 years	328 Participants n=503 Participants
Age, Categorical >=65 years	175 Participants n=503 Participants
Age, Continuous	55 years n=503 Participants
Sex: Female, Male Female	121 Participants n=503 Participants
Sex: Female, Male Male	382 Participants n=503 Participants
Region of Enrollment Switzerland	251 participants n=503 Participants
Region of Enrollment Australia	55 participants n=503 Participants
Region of Enrollment Austria	94 participants n=503 Participants
Region of Enrollment Germany	20 participants n=503 Participants
Region of Enrollment Netherlands	83 participants n=503 Participants

PRIMARY outcome

Timeframe: From date of spinal cord injury until discharge from primary rehabilitation (i.e. individual time window of observation from a few weeks to about 1 year)

occurrence of pneumonia

Outcome measures

Outcome measures
Measure	Inpatient Rehab n=503 Participants all new SCI in inpatient rehabilitation	Without Pneumonia all study participants without any pneumonia diagnosis during inpatient rehabilitation
Pneumonia	70 Participants	—

SECONDARY outcome

Timeframe: measured at inclusion at 28±12 days post injury (time window) or at 84±14 days post injury (time window) - first measurement of each patient used for analysis

Population: all participants who had measurements

The various lung parameters thus include, vital capacity (FVC), forced expiratory volume in 1 second (FEV1), peak expiratory flow (PEF) and peak cough flow (PCF). The measurement of the 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 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.

Outcome measures

Outcome measures
Measure	Inpatient Rehab n=65 Participants all new SCI in inpatient rehabilitation	Without Pneumonia n=425 Participants all study participants without any pneumonia diagnosis during inpatient rehabilitation
Respiratory Function Measurements FVC	2.60 Liters Standard Deviation 1.10	3.18 Liters Standard Deviation 1.09
Respiratory Function Measurements FEV1	2.20 Liters Standard Deviation 0.90	2.59 Liters Standard Deviation 0.95
Respiratory Function Measurements PEF	292.4 Liters Standard Deviation 130.1	359.3 Liters Standard Deviation 135.0
Respiratory Function Measurements PCF	319.9 Liters Standard Deviation 150.0	374.5 Liters Standard Deviation 140.5

SECONDARY outcome

Timeframe: From date of spinal cord injury until discharge from inpatient rehabilitation (i.e. individual time window of observation from a few weeks to about 1 year)

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.

Outcome measures

Outcome measures
Measure	Inpatient Rehab n=70 Participants all new SCI in inpatient rehabilitation	Without Pneumonia n=433 Participants all study participants without any pneumonia diagnosis during inpatient rehabilitation
Mortality Due to Pneumonia	1 Participants	1 Participants

SECONDARY outcome

Timeframe: measured at inclusion at 28±12 days post injury (time window) or at 84±14 days post injury (time window) - first measurement of each patient used for analysis

Population: all participants who had measurements

maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) The measurement will be conducted in sitting position in the own wheelchair or for pedestrians on a chair . 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 greatest value of each parameter will be used for analysis.

Outcome measures

Outcome measures
Measure	Inpatient Rehab n=65 Participants all new SCI in inpatient rehabilitation	Without Pneumonia n=425 Participants all study participants without any pneumonia diagnosis during inpatient rehabilitation
Respiratory Muscle Strength MIP	60.4 cmH2O Standard Deviation 24.8	72.4 cmH2O Standard Deviation 29.4
Respiratory Muscle Strength MEP	50.5 cmH2O Standard Deviation 24.8	78.0 cmH2O Standard Deviation 37.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Inpatient Rehab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Gabi Mueller

Swiss Paraplegic Research

Phone: +41419395563

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place