NIV and Glottis-diaphragm Synchrony

NCT ID: NCT01791335

Last Updated: 2015-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Noninvasive Ventilation NAVA Catheter Hypercapnic Exacerbation COPD

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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COPD patients receiving NIV

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Nijmegen

OTHER

Sponsor Role lead

Responsible Party

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Leo Heunks

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Medical Centre Radboud

Nijmegen, Gelderland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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L Heunks, MD PhD

Role: CONTACT

0243617273

Facility Contacts

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L Heunks, MD PhD

Role: primary

0243617273

E Oppersma, MSc

Role: backup

0243617273

References

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Oppersma E, Doorduin J, Roesthuis LH, van der Hoeven JG, Veltink PH, Heunks LM. Patient-Ventilator Interaction During Noninvasive Ventilation in Subjects With Exacerbation of COPD: Effect of Support Level and Ventilator Mode. Respir Care. 2020 Sep;65(9):1315-1322. doi: 10.4187/respcare.07159. Epub 2020 Mar 10.

Reference Type DERIVED
PMID: 32156788 (View on PubMed)

Other Identifiers

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NIVGlottis

Identifier Type: -

Identifier Source: org_study_id

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