Study Results
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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COMPLETED
NA
197 participants
INTERVENTIONAL
2016-09-30
2020-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Decrease in duration
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.
Protocol for weaning of noninvasive ventilation
3 protocols for weaning of noninvasive ventilation will be compared
Decrease in pressure and duration
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.
Protocol for weaning of noninvasive ventilation
3 protocols for weaning of noninvasive ventilation will be compared
Abrupt discontinuation of NIV
Patients will be disconnected from NIV and oxygenated with a nasal cannula. Oxygen flow will be limited to a maximum of 5L/min.
Protocol for weaning of noninvasive ventilation
3 protocols for weaning of noninvasive ventilation will be compared
Interventions
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Protocol for weaning of noninvasive ventilation
3 protocols for weaning of noninvasive ventilation will be compared
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Bologna
OTHER
Marmara University
OTHER
Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital
OTHER
Dokuz Eylul University
OTHER
Cukurova University
OTHER
Ospedale San Donato
OTHER
University of Milan
OTHER
Baskent University
OTHER
Responsible Party
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Aylin Ozsancak Ugurlu
MD
Principal Investigators
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Stefano Nava
Role: STUDY_CHAIR
Bologna University
Begum Ergan
Role: STUDY_DIRECTOR
Dokuz Eylul University
Sait Karakurt
Role: PRINCIPAL_INVESTIGATOR
Marmara University
Ezgi Ozyılmaz
Role: PRINCIPAL_INVESTIGATOR
Cukurova University
Raffaele Scala
Role: PRINCIPAL_INVESTIGATOR
San Donato Hospital
Fabiano Di Marco
Role: PRINCIPAL_INVESTIGATOR
Milan University
Zuhal Karakurt
Role: PRINCIPAL_INVESTIGATOR
Sureyyapasa Center for Chest Diseases and Thoracic Surgery Training and Investiagation Hospital
Locations
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San Donato Hospital
Arezzo, , Italy
Bologna University
Bologna, , Italy
Milan University
Milan, , Italy
Cukurova University
Adana, , Turkey (Türkiye)
Sureyyapasa Center for Chest Diseases and Thoracic Surgery Training and Investiagation Hospital
Istanbul, , Turkey (Türkiye)
Baskent University
Istanbul, , Turkey (Türkiye)
Marmara University
Istanbul, , Turkey (Türkiye)
Dokuz Eylul University
Izmir, , Turkey (Türkiye)
Countries
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Other Identifiers
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BaskentU
Identifier Type: -
Identifier Source: org_study_id
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