Effect of Air-stacking on Peak Cough Flow in Patients With Acute Cervical or High Thoracic Spinal Cord Injury

Study Overview
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Brief Summary
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Respiratory complications continue to be one of the leading causes of morbidity and mortality in people with spinal cord injury, especially among cervical and higher thoracic injuries. Both inspiratory and expiratory function are often severely decreased, leading to respiratory complications, such as atelectasis, pneumonia and ventilatory failure. The prevention of these respiratory complications needs to begin immediately after injury. To achieve effective expelling of secretions before they form mucus plugs, it is essential to improve patients ability to cough. Manually assisting the cough is one way of increasing cough flow, but an effective cough also requires adequate lung volumes. The emphasis should therefore be on expansion of the lungs before coughing. One way of expanding the lungs is by air-stacking. In air-stacking insufflations are stacked in the lungs to maximally expand them. Cough can be valued by measuring Peak Cough Flow (PCF). By combining air-stacking with manually assisted cough the PCF can be increased sufficiently. The aim of this study is to compare the effect of two different air-stacking techniques on PCF, air-stacking on a respirator versus air-stacking with a manual resuscitator.

Official Title
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Effect of Two Different Air-stacking Techniques, Combined With Manually Assisted Cough, on Peak Cough Flow (PCF) in Patients With Acute Cervical or High Thoracic Spinal Cord Injury

Conditions
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Spinal Cord Injury, Tetraplegia

Intervention / Treatment
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* Procedure: Air-stacking with a manual resuscitator
* Procedure: Air-stacking with ventilator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute cervical or high thoracic spinal cord injury admitted to the ICU Exclusion Criteria: substantial abdominal or thoracic injury substantial brain damage intubated or tracheostomized patients not able to cooperate pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Airstacking with manual resuscitator<br>Air-stacking is a type of lung volume recruitment technique where insufflations are stacked in the lungs to maximally expand them, here done with a manual resuscitator. | Procedure: Air-stacking with a manual resuscitator<br>* Stacking air into the lungs up to maximal insufflation capacity (MIC)with a manual resuscitator<br>* Other names: Lung volume recruitment technique;|
| Active Comparator: Air-stacking with ventilator<br>Air-stacking is a type of lung volume recruitment technique where insufflations are stacked in the lungs to maximally expand them, here done with a ventilator. | Procedure: Air-stacking with ventilator<br>* Stacking air into the lungs to maximal insufflation capacity (MIC) with ventilator<br>* Other names: Lung volume recruitment technique;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak cough flow (PCF) |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient preference of air-stacking technique |  | 2 weeks | 
| Physiotherapist preference of air-stacking technique |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory complications, respiratory insufficiency, respiratory therapy