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NIV and Glottis-diaphragm Synchrony

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2015 by Leo Heunks, University Medical Center Nijmegen.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01791335
First Posted: February 13, 2013
Last Update Posted: June 10, 2015
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Leo Heunks, University Medical Center Nijmegen
  Purpose
Noninvasive ventilation (NIV) can provide ventilatory support in selected patients with acute respiratory failure, for instance due to acute exacerbation of COPD and acute heart failure. Advantages of noninvasive ventilation compared to invasive mechanical ventilation include absence of complications associated with endotracheal intubation, lower risk of pneumonia, lower level or even absence of sedation and the ability of the patient to verbally communicate. However, in approximately 30% of patients NIV fails and endotracheal intubation is needed to provide optimal ventilatory support. Surprisingly, very few studies have investigated why patients fail on NIV. Clinical observations indicated that agitation, delirium and most importantly asynchrony between patient and ventilator play a role in unsuccessful support with NIV. The upper airways are bypassed during endotracheal intubation. However, with NIV the upper airways may play a role in the efficiency of ventilatory support. In normal breathing the upper airways actively dilate before initiation of inspiratory flow. This is a highly appropriate response as it prevents narrowing of the upper airways during inspiration, which would result in elevated inspiratory resistance. Experiments in newborn lambs have shown that NIV has profound effects on physiology of the upper airways. Positive pressure during inspiration results in constriction of upper airway muscles in the early phase of inspiration. This results in elevated upper airway resistance with lower tidal volume delivered to the lungs. Subsequent studies revealed that reflexes that mediate this response originate in vagal afferences located in the lower airways. From an evolutionary point of view this might be an appropriate response, as high pressure delivered to the lungs may induce barotraumas. However, these responses may negatively affect the efficiency of ventilatory support delivered during NIV. The understanding of upper airway constriction and dilation during NIV is rudimentary. This study aims at determining the effect of NIV on regulation of upper airway patency in patients with COPD.

Condition
Noninvasive Ventilation NAVA Catheter Hypercapnic Exacerbation COPD

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of Noninvasive Ventilation on the Synchrony of the Upper Airways and Inspiration.

Further study details as provided by Leo Heunks, University Medical Center Nijmegen:

Primary Outcome Measures:
  • The extent of glottis closure during diaphragm activation and the time delay in glottis opening with respect to diaphragm activity [ Time Frame: 1 Day ]

Estimated Enrollment: 10
Study Start Date: October 2012
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
COPD patients receiving NIV

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patient population for this study will be included from the intensive care. All patients at the intensive care unit who are in clinical need of noninvasive mechanical ventilation due to hypercapnic COPD and with a NAVA catheter in situ, will be screened and asked for informed consent to participate.
Criteria

Inclusion Criteria:

  • Informed consent
  • COPD
  • Hypercapnic respiratory acidosis
  • Clinical need of NIV ventilation on the intensive care
  • NAVA catheter in situ

Exclusion Criteria:

  • Pre-existent muscle disease (congenital or acquired) or diseases / disorders known to be associated with myopathy including auto-immune diseases.
  • Diabetes
  • Upper airway/esophageal/mouth or face pathology (i.e. recent surgery, esophageal varices, diaphragmatic hernia)
  • Recent (< 1 month) nasal bleeding
  • Allergic to xylocaïne
  Contacts and Locations
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): NCT01791335


Contacts
Contact: L Heunks, MD PhD 0243617273 l.heunks@ic.umcn.nl

Locations
Netherlands
University Medical Centre Radboud Recruiting
Nijmegen, Gelderland, Netherlands, 6500HB
Contact: L Heunks, MD PhD    0243617273    l.heunks@ic.umcn.nl   
Contact: E Oppersma, MSc    0243617273    e.oppersma@ic.umcn.nl   
Principal Investigator: L Heunks, MD PhD         
Sponsors and Collaborators
University Medical Center Nijmegen
  More Information

Responsible Party: Leo Heunks, MD PhD, University Medical Center Nijmegen
ClinicalTrials.gov Identifier: NCT01791335     History of Changes
Other Study ID Numbers: NIVGlottis
First Submitted: February 12, 2013
First Posted: February 13, 2013
Last Update Posted: June 10, 2015
Last Verified: June 2015

Keywords provided by Leo Heunks, University Medical Center Nijmegen:
Glottis
Respiratory Muscles
Upper airway
Noninvasive ventilation

Additional relevant MeSH terms:
Hypercapnia
Signs and Symptoms, Respiratory
Signs and Symptoms