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

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01046175
• Other study ID #: S-09326b
• Status: Withdrawn
• Phase: Phase 2
• First received: December 22, 2009
• Last updated: November 11, 2010
• Start date: February 2010
• Est. completion date: June 2011

Study information

• Verified date: December 2009
• Source: Ullevaal University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 10
• Est. completion date: June 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Tetraplegia

Intervention

Procedure:
• Air-stacking with a manual resuscitator
Stacking air into the lungs up to maximal insufflation capacity (MIC)with a manual resuscitator
• Air-stacking with ventilator
Stacking air into the lungs to maximal insufflation capacity (MIC) with ventilator

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Ullevaal	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Ullevaal University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak cough flow (PCF)		2 weeks	No
Secondary	Patient preference of air-stacking technique		2 weeks	No
Secondary	Physiotherapist preference of air-stacking technique		2 weeks	No