Hypercapnic Respiratory FailureNCT03398239
Comparison of BPAP ST/T and BPAP ST / T Mode With AVAPS for Hypercapnic Respiratory Failure in ED
A study testing Noninvasive mechanical ventilation in people with Hypercapnic Respiratory Failure, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the present study; To compare the effects of respiratory support options available for NIMV at the emergency department; i.e. AVAPS and ST/T modes, on the patient's pCO2 values, additional treatment need (another non-invasive ventilation method or endotracheal intubation) and the duration of stay in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercapnic Respiratory Failure
- What is being tested?
- Noninvasive mechanical ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2016to Aug 2017
- Phase
- Interventional
- 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
Who may be able to join
- PaCO2 > 45mmHg and any of the following
- SaO2 <90% on air
- SaO2 <93% on >6 Litres O2/min
- Inability to speak in sentences due to respiratory distress
- Respiratory rate > 24/min
- Altered mental status
- The use of accessory muscles of respiration
Who cannot join
- Respiratory arrest or unstable cardiorespiratory status
- Suspected Pneumothorax
- Urgent need for intubation
- Systolic blood pressure < 90 mmHg
- Inability to protect airway
- Facial deformity
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- Facial, esophageal, or gastric surgery history
- All trauma patients
- Acute myocardial infarction
- Severe arrythmias
- Refractory nausea and vomiting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dokuz Eylul University School of Medicine
The aim of the present study; To compare the effects of respiratory support options available for NIMV at the emergency department; i.e. AVAPS and ST/T modes, on the patient's pCO2 values, additional treatment need (another non-invasive ventilation method or endotracheal intubation) and the duration of stay in hospital.
Read the detailed description
Non-invasive positive pressure ventilation (NIMV) is a life-saving procedure for patients with hypoxic and/or hypercapnic respiratory failure. AVAPS (average volume assured pressure support) is a noninvasive ventilation mode which has been developed to assure volume and pressure controlled respiratory support. AVAPS can ensure a constant tidal air volume to the patient with variable pressure support. Thus the positive features of the volume and pressure controlled support, which have a positive impact on the healing and recovery processes are combined.
This study aims to compare, in a randomized order, BPAP ST/T and BPAP ST / T Mode with AVAPS, in patients with hypercapnic respiratory failure in the emergency department.
Subjects: One hundred and two patients with hypercapnic respiratory failure will be included.
Primary outcome; decrease in the PaCO2 values
Secondary outcomes are stated as; Failure of treatment options, or change of the NIMV mode due to patient noncompliance or the patient's need for intubation and length of hospital stay (length of stay in the hospital from the emergency department).
- Conditions
- Hypercapnic Respiratory Failure
- Being tested
- Noninvasive mechanical ventilation
- Keywords
- respiratory failure, hypercapnia, BPAP, AVAPS
- Medical subject headings
- Respiratory Insufficiency, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive mechanical ventilationDevice
| Study group | Role | What they receive |
|---|---|---|
| BPAP ST/T | Active comparator | Non-invasive Ventilation with BPAP ST/T mode Receives: Device: Noninvasive mechanical ventilation |
| AVAPS | Experimental | Non-invasive Ventilation with AVAPS mode Receives: Device: Noninvasive mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaCO2 values
Will measure change in PaCO2 values in the blood gase analysis of patients comparing those treated with BPAP ST/T and those with AVAPS
Measured: On arrival, at one hour, and at two hourly intervals thereafter
Secondary outcomes (3)
Failure of treatment options
Change of the NIMV mode due to patient noncompliance (switching to the second mode) or the patient's need for intubation during the treatment
Measured: During the treatment
Length of hospital stay
Length of hospital stay in the hospital (From the emergency department admission)
Measured: up to 6 months
The time of treatment
The sum of the noninvasive ventilation time in the emergency department.
Measured: During the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start20 Oct 2016
- Primary completion20 Jul 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypercapnic Respiratory FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Başak Bayram, Dokuz Eylul University
- Investigators
- Başak Bayram, MD, Study director, Dokuz Eylul University, School of Medicine, Department of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398239
- Sponsor's protocol ID
- 2089357
- Status last verified
- Jan 2018
- First submitted
- 30 Nov 2016
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dokuz Eylul University School of Medicine
- ClinicalTrials.gov ID
- NCT03398239
- Acronym / sponsor ID
- 2089357
- Conditions
- Hypercapnic Respiratory Failure
- Keywords
- respiratory failure, hypercapnia, BPAP, AVAPS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 20 Oct 2016 (actual)
- Primary completion
- 20 Jul 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 12 Jan 2018 (actual)
- 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.
The aim of the present study; To compare the effects of respiratory support options available for NIMV at the emergency department; i.e. AVAPS and ST/T modes, on the patient's pCO2 values, additional treatment need (another non-invasive ventilation method or endotracheal intubation) and the duration of stay in hospital.
Detailed description
Non-invasive positive pressure ventilation (NIMV) is a life-saving procedure for patients with hypoxic and/or hypercapnic respiratory failure. AVAPS (average volume assured pressure support) is a noninvasive ventilation mode which has been developed to assure volume and pressure controlled respiratory support. AVAPS can ensure a constant tidal air volume to the patient with variable pressure support. Thus the positive features of the volume and pressure controlled support, which have a positive impact on the healing and recovery processes are combined.
This study aims to compare, in a randomized order, BPAP ST/T and BPAP ST / T Mode with AVAPS, in patients with hypercapnic respiratory failure in the emergency department.
Subjects: One hundred and two patients with hypercapnic respiratory failure will be included.
Primary outcome; decrease in the PaCO2 values
Secondary outcomes are stated as; Failure of treatment options, or change of the NIMV mode due to patient noncompliance or the patient's need for intubation and length of hospital stay (length of stay in the hospital from the emergency department).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPAP ST/T | Active comparator | Device: Noninvasive mechanical ventilationNon-invasive Ventilation with BPAP ST/T mode |
| AVAPS | Experimental | Device: Noninvasive mechanical ventilationNon-invasive Ventilation with AVAPS mode |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- PaCO2 > 45mmHg and any of the following
- SaO2 <90% on air
- SaO2 <93% on >6 Litres O2/min
- Inability to speak in sentences due to respiratory distress
- Respiratory rate > 24/min
Key exclusion criteria (11 listed)
- Respiratory arrest or unstable cardiorespiratory status
- Suspected Pneumothorax
- Urgent need for intubation
- Systolic blood pressure < 90 mmHg
- Inability to protect airway
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 |
|---|---|---|
| Noninvasive mechanical ventilation | Device | AVAPS, BPAP ST/T |
Primary outcome
PaCO2 values
Time frame: On arrival, at one hour, and at two hourly intervals thereafter
Will measure change in PaCO2 values in the blood gase analysis of patients comparing those treated with BPAP ST/T and those with AVAPS
3 secondary outcomes
Failure of treatment options
Time frame: During the treatment
Length of hospital stay
Time frame: up to 6 months
The time of treatment
Time frame: During the treatment
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 Jan 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Hypercapnic Respiratory Failure
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Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
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Bedside Spirometry for Acute Lung Injury
Respiratory Insufficiency
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Role of HFNC During FOB in Patients With Respiratory Failure
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RESET-COPD Cohort: Real-Time Monitoring and Early Warning in COPD Patients Receiving Home NPPV
Pulmonary Disease, Chronic Obstructive (COPD), Chronic Respiratory Failure With Hypercapnia
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.
Başak Bayram, MD study director
Dokuz Eylul University, School of Medicine, Department of Emergency Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive mechanical ventilation in people with Hypercapnic Respiratory Failure, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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 7 inclusion and 11 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 Jan 2018. 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 Turkey (Türkiye). 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?
PaCO2 values (time frame: On arrival, at one hour, and at two hourly intervals thereafter). 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 Jan 2018.