NIV and Glottis-diaphragm Synchrony
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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. |
- 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 |
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.
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| Contact: L Heunks, MD PhD | 0243617273 | l.heunks@ic.umcn.nl |
| 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 | |
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 |
Additional relevant MeSH terms:
|
Hypercapnia Pulmonary Disease, Chronic Obstructive Signs and Symptoms, Respiratory Signs and Symptoms |
Lung Diseases, Obstructive Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 18, 2013