Clinical trial NCT02845076: Weaning From Noninvasive Ventilation
Official title: Weaning From Noninvasive Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercapnic Respiratory Failure
Weaning Failure
Noninvasive Ventilation
Keywords: Noninvasive ventilation
Respiratory insufficiency
Hypercapnia
ventilator weaning
Lead sponsor: Baskent University
Sponsor class: OTHER
Collaborators: name: University of Bologna
name: Marmara University
name: Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital
name: Dokuz Eylul University
name: Cukurova University
name: Ospedale San Donato
name: University of Milan
First posted: 2016-07-27
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

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
* 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:

* 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

Primary outcomes:
measure: The comparison of total duration of NIV after randomization
timeFrame: up to 10 days
Secondary outcomes:
measure: Rate of NIV re-institution
timeFrame: 10 days of NIV discontinuation
measure: NIV weaning success rates
timeFrame: 10 days of NIV discontinuation
measure: Duration of ICU stay
timeFrame: up to 24 weeks
measure: Rates of intubation
timeFrame: first 5 days of NIV discontinuation
measure: In-hospital mortality
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Arezzo
country: Italy
facility: San Donato Hospital
city: Bologna
country: Italy
facility: Bologna University
city: Milan
country: Italy
facility: Milan University
city: Adana
country: Turkey
facility: Cukurova University
city: Istanbul
country: Turkey
facility: Sureyyapasa Center for Chest Diseases and Thoracic Surgery Training and Investiagation Hospital
city: Istanbul
country: Turkey
facility: Baskent University
city: Istanbul
country: Turkey
facility: Marmara University
city: İzmir
country: Turkey
facility: Dokuz Eylul University
Study officials:
affiliation: Bologna University
name: Stefano Nava
role: STUDY_CHAIR
affiliation: Dokuz Eylul University
name: Begum Ergan
role: STUDY_DIRECTOR
affiliation: Marmara University
name: Sait Karakurt
role: PRINCIPAL_INVESTIGATOR
affiliation: Cukurova University
name: Ezgi Ozyılmaz
role: PRINCIPAL_INVESTIGATOR
affiliation: San Donato Hospital
name: Raffaele Scala
role: PRINCIPAL_INVESTIGATOR
affiliation: Milan University
name: Fabiano Di Marco
role: PRINCIPAL_INVESTIGATOR
affiliation: Sureyyapasa Center for Chest Diseases and Thoracic Surgery Training and Investiagation Hospital
name: Zuhal Karakurt
role: PRINCIPAL_INVESTIGATOR
References: