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

NCT01046175 | Withdrawn Phase 2

• 1 other identifier: S-09326b
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury; Tetraplegia

Keywords

Respiratory complications; respiratory insufficiency; respiratory therapy

Outcome Measures

Primary Outcomes (1)

• Peak cough flow (PCF)

  2 weeks

Secondary Outcomes (2)

• Patient preference of air-stacking technique

  2 weeks

• Physiotherapist preference of air-stacking technique

  2 weeks

Study Arms (2)

Airstacking with manual resuscitator

EXPERIMENTAL

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

Air-stacking with ventilator

ACTIVE COMPARATOR

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

Interventions

Air-stacking with a manual resuscitator PROCEDURE

Stacking air into the lungs up to maximal insufflation capacity (MIC)with a manual resuscitator

Also known as: Lung volume recruitment technique

Airstacking with manual resuscitator

Air-stacking with ventilator PROCEDURE

Stacking air into the lungs to maximal insufflation capacity (MIC) with ventilator

Also known as: Lung volume recruitment technique

Air-stacking with ventilator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• acute cervical or high thoracic spinal cord injury admitted to the ICU

You may not qualify if:

• substantial abdominal or thoracic injury
• substantial brain damage
• intubated or tracheostomized patients
• not able to cooperate
• pregnant women

Sponsors & Collaborators

• Ullevaal University Hospital: lead

Study Sites (1)

Oslo University Hospital, Ullevaal

Oslo, 0407, Norway

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia; Respiratory Insufficiency

Interventions

Ventilators, Mechanical

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Helene L Soberg, PhD

  Oslo University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 22, 2009
• First Posted: January 11, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 15, 2010

Record last verified: 2009-12

Locations

NO (1)