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

Primary Purpose

Spinal Cord Injury, Tetraplegia

Status

Withdrawn

Phase

Phase 2

Locations

Norway

Study Type

Interventional

Intervention

Air-stacking with a manual resuscitator

Air-stacking with ventilator

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Respiratory complications, respiratory insufficiency, respiratory therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Oslo University Hospital, Ullevaal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Airstacking with manual resuscitator

Air-stacking with ventilator

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Peak cough flow (PCF)

Secondary Outcome Measures

Patient preference of air-stacking technique

Physiotherapist preference of air-stacking technique

Full Information

NCT ID

NCT01046175

First Posted

December 22, 2009

Last Updated

November 11, 2010

Sponsor

Ullevaal University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01046175

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Withdrawn

Why Stopped

Lack of patients. Investigator changed job.

Study Start Date

February 2010 (undefined)

Primary Completion Date

February 2011 (Anticipated)

Study Completion Date

June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Ullevaal University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injury, Tetraplegia

Keywords

Respiratory complications, respiratory insufficiency, respiratory therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Airstacking with manual resuscitator

Arm Type

Experimental

Arm Description

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.

Arm Title

Air-stacking with ventilator

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Air-stacking with a manual resuscitator

Other Intervention Name(s)

Lung volume recruitment technique

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Air-stacking with ventilator

Other Intervention Name(s)

Lung volume recruitment technique

Intervention Description

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

Primary Outcome Measure Information:

Title

Peak cough flow (PCF)

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Patient preference of air-stacking technique

Time Frame

2 weeks

Title

Physiotherapist preference of air-stacking technique

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Helene L Soberg, PhD

Organizational Affiliation

Oslo University Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Oslo University Hospital, Ullevaal

City

Oslo

ZIP/Postal Code

0407

Country

Norway

12. IPD Sharing Statement

Learn more about this trial

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

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