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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Spinal Cord Injury; Tetraplegia
• Intervention / Treatment: Procedure: Air-stacking with a manual resuscitator; Procedure: Air-stacking with ventilator

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0407
    • Oslo University Hospital, Ullevaal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Lung volume recruitment technique

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ullevaal University Hospital
• Investigators: Study Chair: Helene L Soberg, PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (ANTICIPATED): February 1, 2011
• Study Completion (ANTICIPATED): June 1, 2011

Study Registration Dates

• First Submitted: December 22, 2009
• First Submitted That Met QC Criteria: January 8, 2010
• First Posted (ESTIMATE): January 11, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): November 15, 2010
• Last Update Submitted That Met QC Criteria: November 11, 2010
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: respiratory insufficiency; respiratory therapy; Respiratory complications
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Trauma, Nervous System; Spinal Cord Diseases; Paralysis; Wounds and Injuries; Spinal Cord Injuries; Quadriplegia
• Other Study ID Numbers: S-09326b