Hypercapnic Respiratory FailureWEANIVNCT02845076
Weaning From Noninvasive Ventilation
A study testing Protocol for weaning of noninvasive ventilation in people with Hypercapnic Respiratory Failure and Weaning Failure, run by Baskent University at 8 sites in 2 countries.
Trial summary
Noninvasive ventilation (NIV) weaning strategies differ considerably from one another. These strategies have yet not been compared to each other. Therefore, the investigators planned to perform a prospective, randomized, pilot study involving hypercapnic acute respiratory failure patients ready to be weaned off from… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercapnic Respiratory Failure, Weaning Failure, Noninvasive Ventilation
- What is being tested?
- Protocol for weaning of noninvasive ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Sep 2016to Mar 2020
- 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
- Patients will be screened by the physician 24 hours (±6 hours) after initiation of NIV treatment if:
- Age ≥18 years old
- Hypercapnic ARF ( baseline pH<7.35, paCO2>45 mmHg, BORG>4)
- Breathing frequency< 25 bpm under NIV
- pH >7.35 under NIV
- 10% or more decrease from baseline PaCO2 under NIV
Show all 21Show fewer
- Kelly ≤ 2 under NIV (Alert. Follows simple/3 step complex commands)
- PaO2 between 60 and 70 mmHg under NIV
- No need for sedation
- Systolic blood pressure 90-180 mmHg without vasopressors
- Body temperature 36-38°C
- Heart rate 50-120 bpm
- The patient will be enrolled to the study and will be randomized to one of the NIV weaning protocols, if passes daily weaning criteria listed below after 1 hour of spontaneous breathing (with supplementary oxygen),
- Respiratory rate 8-30 bpm
- Systolic blood pressure 90-180 mmHg without vasopressors
- Body temperature 36-38°C
- Heart rate 50-120 bpm
- Neurologic score of Kelly ≤2 (Alert. Follows simple/ 3-step complex commands),
- SaO2 ≥88-92% with a FiO2≤40%.
- pH≥7.35
- Absence of severe dyspnea (BORG>4).
Who cannot join
- Age <18 years old
- NIV use at home for chronic respiratory failure
- CPAP use for acute respiratory failure
- NIV use as palliative treatment
- Severe heart failure with cardiac index ≤ 2 L/min/m2
- Severe hepatic failure with bilirubin ≥ 34.2µmol/L
- Severe renal failure with creatinine ≥ 220 µmol/L
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Turkey (Türkiye)5 sites
Cukurova University
Adana
Sureyyapasa Center for Chest Diseases and Thoracic Surgery Training and Investiagation Hospital
Istanbul, 34854
Baskent University
Istanbul
Marmara University
Istanbul
Dokuz Eylul University
Izmir
Italy3 sites
San Donato Hospital
Arezzo
Bologna University
Bologna
Milan University
Milan
About this study
Noninvasive ventilation (NIV) weaning strategies differ considerably from one another. These strategies have yet not been compared to each other. Therefore, the investigators planned to perform a prospective, randomized, pilot study involving hypercapnic acute respiratory failure patients ready to be weaned off from NIV. The investigators are going to compare the success rate of NIV weaning and the duration of NIV after randomization between 3 NIV weaning methods: gradual decrease in duration of NIV or level of ventilator support, and abrupt discontinuation of NIV.
- Being tested
- Protocol for weaning of noninvasive ventilation
- Keywords
- Noninvasive ventilation, Respiratory insufficiency, Hypercapnia, ventilator weaning
- 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.
Protocol for weaning of noninvasive ventilationOther
3 protocols for weaning of noninvasive ventilation will be compared
| Study group | Role | What they receive |
|---|---|---|
| Decrease in duration | Active comparator | Weaning will be started with the liberation of patient from NIV during day-time and then nighttime support will be gradually reduced. From day 2 the daytime NIV will be gradually decreased in steps of at least 2 hours/day at the attending discretion. At day 2, nighttime discontinuation will be considered. When a patient reaches without the presence of any reinstitution criteria, the duration of NIV use as 4 hours per 16 hours during daytime, it will be liberated definitively from NIV. Receives: Other: Protocol for weaning of noninvasive ventilation |
| Decrease in pressure and duration | Active comparator | Weaning will be started with the liberation of patient from NIV during day-time and then nighttime support will be gradually reduced. The level of pressure support will be decreased by 2-4 cmH2O per 4 hours during daytime in patients with good tolerance, with no change at night time. From day 2 the daytime NIV will be gradually decreased in steps of at least 2 hours/day at the attending discretion. At day 2, nighttime discontinuation will be considered, based on the vitals and ABGs recorded at 8 pm (see above), with gradual decrease of at least 2 hrs/night. When a patient reaches without the presence of any reinstitution criteria, the level of PS of 8 cmH20, it will be liberated definitively from NIV. Receives: Other: Protocol for weaning of noninvasive ventilation |
| Abrupt discontinuation of NIV | Active comparator | Patients will be disconnected from NIV and oxygenated with a nasal cannula. Oxygen flow will be limited to a maximum of 5L/min. Receives: Other: Protocol for weaning of noninvasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The comparison of total duration of NIV after randomization
The patients will be considered as 'weaning failure' if:
- The participant will meet the NIV reinstitution or intubation criteria during the weaning phase or within the first 5 days of NIV discontinuation
- Weaning from NIV was not possible If the failing patient stabilizes afterwards and passes the screening and weaning criteria, the patient will be weaned again with the same protocol. If the patient fails weaning trials 3 times, then the patient will not be re-considered for further enrollment.
Measured: up to 10 days
Secondary outcomes (5)
Rate of NIV re-institution
Measured: 10 days of NIV discontinuation
NIV weaning success rates
Measured: 10 days of NIV discontinuation
Duration of ICU stay
Measured: up to 24 weeks
Rates of intubation
Measured: first 5 days of NIV discontinuation
In-hospital mortality
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2020
- Study completionMar 2020
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
- None (open label)
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bologna, Marmara University, Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital, Dokuz Eylul University, Cukurova University, Ospedale San Donato, University of Milan
- Responsible party
- Principal investigator, Aylin Ozsancak Ugurlu, Baskent University
- Investigators
- Stefano Nava, Study chair, Bologna UniversityBegum Ergan, Study director, Dokuz Eylul UniversitySait Karakurt, Principal investigator, Marmara UniversityEzgi Ozyılmaz, Principal investigator, Cukurova UniversityRaffaele Scala, Principal investigator, San Donato HospitalFabiano Di Marco, Principal investigator, Milan UniversityZuhal Karakurt, Principal investigator, Sureyyapasa Center for Chest Diseases and Thoracic Surgery Training and Investiagation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845076
- Sponsor's protocol ID
- BaskentU
- Acronym
- WEANIV
- Status last verified
- Jul 2020
- First submitted
- 28 Mar 2016
- Last updated
- 10 Jul 2020
- 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 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weaning From Noninvasive Ventilation
- ClinicalTrials.gov ID
- NCT02845076
- Acronym / sponsor ID
- WEANIV / BaskentU
- Keywords
- Noninvasive ventilation, Respiratory insufficiency, Hypercapnia, ventilator weaning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Collaborators
- University of Bologna, Marmara University, Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital, Dokuz Eylul University, Cukurova University, Ospedale San Donato, University of Milan
- Study start
- Sep 2016 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 27 Jul 2016 (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.
Noninvasive ventilation (NIV) weaning strategies differ considerably from one another. These strategies have yet not been compared to each other. Therefore, the investigators planned to perform a prospective, randomized, pilot study involving hypercapnic acute respiratory failure patients ready to be weaned off from NIV. The investigators are going to compare the success rate of NIV weaning and the duration of NIV after randomization between 3 NIV weaning methods: gradual decrease in duration of NIV or level of ventilator support, and abrupt discontinuation of NIV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Decrease in duration | Active comparator | Other: Protocol for weaning of noninvasive ventilationWeaning will be started with the liberation of patient from NIV during day-time and then nighttime support will be gradually reduced. From day 2 the daytime NIV will be gradually decreased in steps of at least 2 hours/day at the attending discretion. At day 2, nighttime discontinuation will be considered. When a patient reaches without the presence of any reinstitution criteria, the duration of NIV use as 4 hours per 16 hours during daytime, it will be liberated definitively from NIV. |
| Decrease in pressure and duration | Active comparator | Other: Protocol for weaning of noninvasive ventilationWeaning will be started with the liberation of patient from NIV during day-time and then nighttime support will be gradually reduced. The level of pressure support will be decreased by 2-4 cmH2O per 4 hours during daytime in patients with good tolerance, with no change at night time. From day 2 the daytime NIV will be gradually decreased in steps of at least 2 hours/day at the attending discretion. At day 2, nighttime discontinuation will be considered, based on the vitals and ABGs recorded at 8 pm (see above), with gradual decrease of at least 2 hrs/night. When a patient reaches without the presence of any reinstitution criteria, the level of PS of 8 cmH20, it will be liberated definitively from NIV. |
| Abrupt discontinuation of NIV | Active comparator | Other: Protocol for weaning of noninvasive ventilationPatients will be disconnected from NIV and oxygenated with a nasal cannula. Oxygen flow will be limited to a maximum of 5L/min. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients will be screened by the physician 24 hours (±6 hours) after initiation of NIV treatment if:
- Age ≥18 years old
- Hypercapnic ARF ( baseline pH<7.35, paCO2>45 mmHg, BORG>4)
- Breathing frequency< 25 bpm under NIV
- pH >7.35 under NIV
Key exclusion criteria (7 listed)
- Age <18 years old
- NIV use at home for chronic respiratory failure
- CPAP use for acute respiratory failure
- NIV use as palliative treatment
- Severe heart failure with cardiac index ≤ 2 L/min/m2
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 |
|---|---|---|
| Protocol for weaning of noninvasive ventilation3 protocols for weaning of noninvasive ventilation will be compared | Other | Abrupt discontinuation of NIV, Decrease in duration, Decrease in pressure and duration |
Primary outcome
The comparison of total duration of NIV after randomization
Time frame: up to 10 days
The patients will be considered as 'weaning failure' if: * The participant will meet the NIV reinstitution or intubation criteria during the weaning phase or within the first 5 days of NIV discontinuation * Weaning from NIV was not possible If the failing patient stabilizes afterwards and passes the screening and weaning criteria, the patient will be weaned again with the same protocol. If the patient fails weaning trials 3 times, then the patient will not be re-considered for further enrollment.
5 secondary outcomes
Rate of NIV re-institution
Time frame: 10 days of NIV discontinuation
NIV weaning success rates
Time frame: 10 days of NIV discontinuation
Duration of ICU stay
Time frame: up to 24 weeks
Rates of intubation
Time frame: first 5 days of NIV discontinuation
In-hospital mortality
Time frame: up to 24 weeks
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 10 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
Stefano Nava study chair
Bologna University
Begum Ergan study director
Dokuz Eylul University
Sait Karakurt principal investigator
Marmara University
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protocol for weaning of noninvasive ventilation in people with Hypercapnic Respiratory Failure and Weaning Failure, run by Baskent University at 8 sites in 2 countries.
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 21 inclusion and 7 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 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Turkey (Türkiye), Italy. 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?
The comparison of total duration of NIV after randomization (time frame: up to 10 days). 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 10 Jul 2020.