Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Bologna | OTHER |
| Marmara University | OTHER |
| Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protocol for weaning of noninvasive ventilation | Other | 3 protocols for weaning of noninvasive ventilation will be compared |
|
| Measure | Description | Time Frame |
|---|---|---|
| The comparison of total duration of NIV after randomization | The patients will be considered as 'weaning failure' if:
| up to 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of NIV re-institution | 10 days of NIV discontinuation | |
| NIV weaning success rates | 10 days of NIV discontinuation | |
| Duration of ICU stay |
Not provided
Inclusion Criteria:
Patients will be screened by the physician 24 hours (±6 hours) after initiation of NIV treatment if:
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),
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stefano Nava | Bologna University | Study Chair |
| Begum Ergan | Dokuz Eylul University | Study Director |
| Sait Karakurt | Marmara University | Principal Investigator |
| Ezgi Ozyılmaz | Cukurova University | Principal Investigator |
| Raffaele Scala | San Donato Hospital | Principal Investigator |
| Fabiano Di Marco | Milan University | Principal Investigator |
| Zuhal Karakurt | Sureyyapasa Center for Chest Diseases and Thoracic Surgery Training and Investiagation Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Donato Hospital | Arezzo | Italy | ||||
| Bologna University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D006935 | Hypercapnia |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D002985 | Clinical Protocols |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D016020 | Epidemiologic Study Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
Not provided
Not provided
| Dokuz Eylul University |
| OTHER |
| Cukurova University | OTHER |
| Ospedale San Donato | OTHER |
| University of Milan | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| up to 24 weeks |
| Rates of intubation | first 5 days of NIV discontinuation |
| In-hospital mortality | up to 24 weeks |
| Bologna |
| Italy |
| Milan University | Milan | Italy |
| Cukurova University | Adana | Turkey (Türkiye) |
| Sureyyapasa Center for Chest Diseases and Thoracic Surgery Training and Investiagation Hospital | Istanbul | 34854 | Turkey (Türkiye) |
| Baskent University | Istanbul | Turkey (Türkiye) |
| Marmara University | Istanbul | Turkey (Türkiye) |
| Dokuz Eylul University | Izmir | Turkey (Türkiye) |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017530 | Health Care Quality, Access, and Evaluation |