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NIV-NAVA vs NIV-PS/PC in Respiratory Insufficiency

NCT ID: NCT02592512

Last Updated: 2017-07-12

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

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-04-30

Brief Summary

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This study evaluates the difference between Non Invasive Ventilation with Neurally Adjusted Ventilatory Assist (NIV-NAVA) and Conventional Non Invasive Ventilation with Pressure Support (PS) or Pressure Control (PC). All the patients are ventilated in each mode for 4 hours. Afterwards they will be subjected to a semi-structured interview where they will be asked to compare the two modes. The hypothesis is that NIV-NAVA will correct patients power of Hydrogen (pH), PaCO2 og PaO2 more quickly than NIV-PS and NIV-NAVA is more comfortable for the patients.

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Detailed Description

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Neurally Adjusted Ventilatory Assist (NAVA) is a ventilation mode where the diaphragm is controlling the amount of ventilatory assistance proportionally through a nasogastric tube containing electrodes which are sending the electrical activities of the diaphragm (Eadi) to the ventilator.

Whereas Conventional ventilation modes like Pressure support or Pressure Control are dependent on the pressure drop or flow reversal to initiate assist delivered to the patient. This is last step of the signal chain leading to inhalation and is subject to disturbances such as intrinsic positive expiratory end pressure (PEEP), hyperinflation and leakage.

Conditions

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Respiratory Insufficiency Acute Respiratory Insufficiency

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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NIV-NAVA

4 hour NIV-NAVA, followed by 4 hour NIV-PS/PC

NIV-NAVA

Intervention Type OTHER

Cross-over study where participants are randomized to start with either NIV-NAVA or NIV-PS/PC for 4 hours, followed by another 4 hours with the other arm.

NIV-PS/PC

Intervention Type OTHER

Cross-over study where participants are randomized to start with either NIV-NAVA or NIV-PS/PC for 4 hours, followed by another 4 hours with the other arm.

NIV-PS/PC

4 hour NIV-PS/PC, followed by 4 hour NIV-NAVA

NIV-NAVA

Intervention Type OTHER

Cross-over study where participants are randomized to start with either NIV-NAVA or NIV-PS/PC for 4 hours, followed by another 4 hours with the other arm.

NIV-PS/PC

Intervention Type OTHER

Cross-over study where participants are randomized to start with either NIV-NAVA or NIV-PS/PC for 4 hours, followed by another 4 hours with the other arm.

Interventions

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NIV-NAVA

Cross-over study where participants are randomized to start with either NIV-NAVA or NIV-PS/PC for 4 hours, followed by another 4 hours with the other arm.

Intervention Type OTHER

NIV-PS/PC

Cross-over study where participants are randomized to start with either NIV-NAVA or NIV-PS/PC for 4 hours, followed by another 4 hours with the other arm.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients admitted at the ICU with acute respiratory insufficiency and therefore have hypoxia(PaO2 \< 7 kPa on atmospheric air) og pH \< 7.35 with non-compensated hypercapnia (PaCO2 \> 6.0 kPa).
* Patients, which according to the departments guidelines are required to treatment with NIV

Exclusion Criteria

* Patients under years of 18.
* Patients without the possibility to give informed consent.
* Patients with neuromuscular or neurological disease.
* Patients with a verified or suspected head trauma.
* Patients with a acknowledged hiatus hernia.
* Patients with an active or suspected active upper GI bleeding.
* Patients which have previously been in the study.
* Patients with a suspected or verified acute coronary syndrome.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vejle Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alan Kimper-Karl, MD

Role: STUDY_CHAIR

Vejle Hospital

Locations

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Vejle Hospital

Vejle, Southern Jetland, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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NIV-NAVA vs NIV-PS/PC

Identifier Type: -

Identifier Source: org_study_id

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