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

Phase 2

Withdrawn

• Conditions: Spinal Cord Injury; Tetraplegia
• Interventions: Procedure: Air-stacking with ventilator; Procedure: Air-stacking with a manual resuscitator

• Registration Number: NCT01046175
• Lead Sponsor: Ullevaal University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-12
• Study First Submitted: 2009-12-22
• Study First Submitted QC: 2010-01-08
• Study First Posted: 2010-01-11
• Study Start: 2010-02
• Last Update Submitted: 2010-11-11
• Last Update Posted: 2010-11-15
• Primary Completion: 2011-02
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Air-stacking with ventilator	Air-stacking with ventilator	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.
Airstacking with manual resuscitator	Air-stacking with a manual resuscitator	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.

Primary Outcome Measures

Name	Time	Method
Peak cough flow (PCF)	2 weeks

Secondary Outcome Measures

Name	Time	Method
Patient preference of air-stacking technique	2 weeks
Physiotherapist preference of air-stacking technique	2 weeks

Trial Locations

Locations (1)

Oslo University Hospital, Ullevaal; 🇳🇴 Oslo, Norway