NCT02592512

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 30, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

July 12, 2017

Status Verified

July 1, 2017

Enrollment Period

1.5 years

First QC Date

October 14, 2015

Last Update Submit

July 11, 2017

Conditions

Respiratory InsufficiencyAcute Respiratory Insufficiency

Keywords

Hypoxiahypercapnia

Outcome Measures

Primary Outcomes (4)

  • Time for normalizing of Power of Hydrogen (pH) in arterial blood gases. Normal pH frame 7.35-7.45.

    8 hours

  • Time for normalizing of Partial pressure of Oxygen (pO2) in arterial blood gases. Normal frame for pO2 7-14,4 (or to the usual level for the patient).

    8 hours

  • Time for normalizing Carbon dioxide partial pressure (pCO2) in arterial blood gases. Normal frames pCO2 4,7-6,4 (or to the usual level for the patient).

    8 hours

  • Electrical activity of the diaphragm (Eadi). Reduction in respiratory work assessed by Eadi (in percentage).

    8 hours

Secondary Outcomes (1)

  • Patient comfort

    24 hours

Study Arms (2)

NIV-NAVA

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

Other: NIV-NAVAOther: NIV-PS/PC

NIV-PS/PC

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

Other: NIV-NAVAOther: NIV-PS/PC

Interventions

NIV-NAVAOTHER

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-NAVANIV-PS/PC
NIV-PS/PCOTHER

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-NAVANIV-PS/PC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted to the ICU at Vejle Hospital, Denmark, with acute respiratory insufficiency.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vejle Hospital

Vejle, Southern Jetland, 7100, Denmark

Location

MeSH Terms

Conditions

Respiratory InsufficiencyHypoxiaHypercapnia

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alan Kimper-Karl, MD

    Vejle Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2015

First Posted

October 30, 2015

Study Start

October 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

July 12, 2017

Record last verified: 2017-07

Locations

DK(1)