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

November 11, 2010 updated by: Ullevaal University Hospital

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Withdrawn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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ullevaal University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-09326b

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spinal Cord Injury

Clinical Trials on Air-stacking with a manual resuscitator

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe