Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 56 of 5283 for:    neuromuscular disease

Mechanical Insufflation -Exsufflation in Children With NMD and Weak Cough

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04081116
Recruitment Status : Recruiting
First Posted : September 9, 2019
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Brit Hov, Oslo University Hospital

Brief Summary:
Neuromuscular diseases (NMD) in children are severe, possibly life-threatening orphan conditions. The children are vulnerable and often subject to rapid deterioration of pulmonary function due to impaired ability to clear airway secretions. The use of mechanical cough augmentation with insufflation-exsufflation (MIE) is a strategy to treat and prevent. Possible major benefits are described, but optimal settings for best efficacy and comfort in children are not established. The project aim to improve the quality of the treatment with MIE in children with NMD and weak cough. On the basis of a bench study a clinical trial aims to examine the most effective MIE settings when used in stable state and when respiratory tract infections are present.

Condition or disease Intervention/treatment Phase
Neuromuscular Diseases in Children Other: Symmetric settings (high pressures/fast rate) Other: Asymmetric settings (Pi<Pe/Ti>Te) Other: Preinclusion settings Not Applicable

Detailed Description:
On the basis of a prevalence study and a bench study different settings will be studied in children with NMD and weak cough to examine if settings derived from the lung model, are optimal to increase the peak cough flow (PCF) and comfort measured by visual analogue scale (VAS) in children with NMD and weak cough.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Three different settings are tested on the same patients but in randomized order.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Participant, care provider, investigator and outcomes assessor are blinded from the order of the settings tested. Only a technician change settings and know the order.
Primary Purpose: Treatment
Official Title: The Optimal Settings of MI-E in Children With NMD and Weak Cough
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MI-E testing symmetric settings
Symmetric settings is one of 3 different settings that will be tested on the same day but in randomized order.
Other: Symmetric settings (high pressures/fast rate)
Describes settings on the MI-E device

Other: Asymmetric settings (Pi<Pe/Ti>Te)
Lower insufflation pressures at longer times

Other: Preinclusion settings
Settings in use at start of study

Experimental: MI-E testing assymetric settings
Asymmetric settings is one of 3 different settings that will be tested on the same day but in randomized order.
Other: Symmetric settings (high pressures/fast rate)
Describes settings on the MI-E device

Other: Asymmetric settings (Pi<Pe/Ti>Te)
Lower insufflation pressures at longer times

Other: Preinclusion settings
Settings in use at start of study

Sham Comparator: Settings in use
Settings in use is one of 3 different settings that will be tested on the same day but in randomized order
Other: Symmetric settings (high pressures/fast rate)
Describes settings on the MI-E device

Other: Asymmetric settings (Pi<Pe/Ti>Te)
Lower insufflation pressures at longer times

Other: Preinclusion settings
Settings in use at start of study




Primary Outcome Measures :
  1. PCF in the MI-E circuit [ Time Frame: 30 minutes. ]
    Recording of maximal value produced by the MI-E device during Cough

  2. Patient reported comfort [ Time Frame: Total time use 30 min ]
    Comfort rated on a Visual Analog Scale (VAS) (0-100) where 100 is very uncomfortable and 0 is very comfortable.


Secondary Outcome Measures :
  1. Carbon dioxide [ Time Frame: maximal time use is 30 min ]
    Transcutaneous trend measurement of CO2 during data collection

  2. Oxygen [ Time Frame: maximal time use is 30 min ]
    Transcutaneous trend measurement of peripheral O2 during data collection

  3. Hart rate [ Time Frame: Total max 30 minutes (During three MI-E trials) ]
    Transcutaneous trend measurement of hart rate during data collection

  4. Patient reported efficacy [ Time Frame: The VAS is recorded after each of the three trials. Total time use 30 min ]
    Efficacy rated on a Visual Analog Scale (0-100) where 100 is not efficient at all and 0 is very efficient.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed neuromuscular disease < 18 years
  • Established use (> 3mnd) of MI-E.
  • Reduced PCF

    • PCF < 270 l/min (when > 12 years)
    • < 5th percentiles for PCF 16 (when 4 - 12 years)
  • Clinical indication (difficulty to clear secretions, audible weak cough, history of pneumonia or frequent or prolonged respiratory tract infections).

Exclusion Criteria:

  • age < 6 mnd
  • obstructive lung disease (hyperinflation or emphysema on x-ray.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04081116


Contacts
Layout table for location contacts
Contact: Brit Hov, MSc +4723015667 uxbrov@ous-hf.no
Contact: Vegard Hovland, PhD +4722118765 uxhovv@ous-hf.no

Locations
Layout table for location information
Norway
Oslo university hospital Recruiting
Oslo, Norway
Contact: Brit Hov         
Sponsors and Collaborators
Oslo University Hospital

Layout table for additonal information
Responsible Party: Brit Hov, Physiotherapist, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04081116     History of Changes
Other Study ID Numbers: 18/12375
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuromuscular Diseases
Nervous System Diseases