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

This study has been withdrawn prior to enrollment.
(Lack of patients. Investigator changed job.)
Sponsor:
Information provided by:
Ullevaal University Hospital
ClinicalTrials.gov Identifier:
NCT01046175
First received: December 22, 2009
Last updated: November 11, 2010
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Spinal Cord Injury
Tetraplegia
Procedure: Air-stacking with a manual resuscitator
Procedure: Air-stacking with ventilator
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Ullevaal University Hospital:

Primary Outcome Measures:
  • Peak cough flow (PCF) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient preference of air-stacking technique [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Physiotherapist preference of air-stacking technique [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: February 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Airstacking with 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.
Procedure: Air-stacking with a manual resuscitator
Stacking air into the lungs up to maximal insufflation capacity (MIC)with a manual resuscitator
Other Name: Lung volume recruitment technique
Active Comparator: 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.
Procedure: Air-stacking with ventilator
Stacking air into the lungs to maximal insufflation capacity (MIC) with ventilator
Other Name: Lung volume recruitment technique

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01046175

Locations
Norway
Oslo University Hospital, Ullevaal
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
Investigators
Study Chair: Helene L Soberg, PhD Oslo University Hospital Ullevaal
  More Information

No publications provided

Responsible Party: Post doc research fellow Helene L. Soberg, Oslo University Hospital, Ullevaal, Dept. of Phys. Med & Rehab.
ClinicalTrials.gov Identifier: NCT01046175     History of Changes
Other Study ID Numbers: S-09326b
Study First Received: December 22, 2009
Last Updated: November 11, 2010
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Ullevaal University Hospital:
Respiratory complications
respiratory insufficiency
respiratory therapy

Additional relevant MeSH terms:
Quadriplegia
Spinal Cord Injuries
Wounds and Injuries
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on April 15, 2014