NIV and Glottis-diaphragm Synchrony

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Medical Center Nijmegen
Sponsor:
Collaborator:
MAQUET
Information provided by (Responsible Party):
Leo Heunks, University Medical Center Nijmegen
ClinicalTrials.gov Identifier:
NCT01791335
First received: February 12, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  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 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: October 2012
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
COPD patients receiving NIV

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
MAQUET
  More Information

No publications provided

Responsible Party: Leo Heunks, MD PhD, University Medical Center Nijmegen
ClinicalTrials.gov Identifier: NCT01791335     History of Changes
Other Study ID Numbers: NIVGlottis
Study First Received: February 12, 2013
Last Updated: February 12, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

ClinicalTrials.gov processed this record on October 20, 2014