Respiratory InsufficiencyNCT02592512
NIV-NAVA vs NIV-PS/PC in Respiratory Insufficiency
An observational study of Respiratory Insufficiency and Acute Respiratory Insufficiency, run by Vejle Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency, Acute Respiratory Insufficiency
- What is being tested?
- NIV-NAVA and NIV-PS/PC
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2015to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the ICU at Vejle Hospital, Denmark, with acute respiratory insufficiency.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Invasive Ventilation With Neurally Adjusted Ventilatory Assist vs NIV Pressure Support or Pressure Control in Treatment of Patients With Acute Respiratory Insufficiency. A Prospective, Randomised, Single Blinded, Crossover Pilot Study
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.
Read the detailed description
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.
- Being tested
- NIV-NAVA, NIV-PS/PC
- Keywords
- Hypoxia, hypercapnia
- Medical subject headings
- Respiratory Insufficiency, Hypoxia, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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-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.
| Study group | Role | What they receive |
|---|---|---|
| NIV-NAVA | 4 hour NIV-NAVA, followed by 4 hour NIV-PS/PC Receives: Other: NIV-NAVA; Other: NIV-PS/PC | |
| NIV-PS/PC | 4 hour NIV-PS/PC, followed by 4 hour NIV-NAVA Receives: Other: NIV-NAVA; Other: NIV-PS/PC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for normalizing of Power of Hydrogen (pH) in arterial blood gases. Normal pH frame 7.35-7.45.
Measured: 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).
Measured: 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).
Measured: 8 hours
Electrical activity of the diaphragm (Eadi). Reduction in respiratory work assessed by Eadi (in percentage).
Measured: 8 hours
Secondary outcomes (1)
Patient comfort
There will be conducted a semi-interview on the subjects. They will be asked:
If they felt any difference in breathing between the two modes. If yes, what was the difference? Which method did you prefer? And why? Do you have any comments?
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan Kimper-Karl, MD, Study chair, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592512
- Sponsor's protocol ID
- NIV-NAVA vs NIV-PS/PC
- Status last verified
- Jul 2017
- First submitted
- 14 Oct 2015
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Ventilation With Neurally Adjusted Ventilatory Assist vs NIV Pressure Support or Pressure Control in Treatment of Patients With Acute Respiratory Insufficiency. A Prospective, Randomised, Single Blinded, Crossover Pilot Study
- ClinicalTrials.gov ID
- NCT02592512
- Acronym / sponsor ID
- NIV-NAVA vs NIV-PS/PC
- Keywords
- Hypoxia, hypercapnia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 30 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIV-NAVA | – | Other: NIV-NAVA, Other: NIV-PS/PC4 hour NIV-NAVA, followed by 4 hour NIV-PS/PC |
| NIV-PS/PC | – | Other: NIV-NAVA, Other: NIV-PS/PC4 hour NIV-PS/PC, followed by 4 hour NIV-NAVA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the ICU at Vejle Hospital, Denmark, with acute respiratory insufficiency.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIV-NAVACross-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. | Other | NIV-NAVA, NIV-PS/PC |
| NIV-PS/PCCross-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. | Other | NIV-NAVA, NIV-PS/PC |
Primary outcome
Time for normalizing of Power of Hydrogen (pH) in arterial blood gases. Normal pH frame 7.35-7.45.
Time frame: 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).
Time frame: 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).
Time frame: 8 hours
Electrical activity of the diaphragm (Eadi). Reduction in respiratory work assessed by Eadi (in percentage).
Time frame: 8 hours
1 secondary outcome
Patient comfort
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Kimper-Karl, MD study chair
Vejle Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Insufficiency and Acute Respiratory Insufficiency, run by Vejle Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time for normalizing of Power of Hydrogen (pH) in arterial blood gases. Normal pH frame 7.35-7.45. (time frame: 8 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017.