Hypercapnic Respiratory Failure, Noninvasive Ventilation, Weaning Failure
Conditions
Keywords
Noninvasive ventilation, Respiratory insufficiency, Hypercapnia, ventilator weaning
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.
Interventions
OTHERProtocol for weaning of noninvasive ventilation
3 protocols for weaning of noninvasive ventilation will be compared
Sponsors
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
Baskent University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The comparison of total duration of NIV after randomization | 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. |
Secondary
| Measure | 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 | up to 24 weeks |
| Rates of intubation | first 5 days of NIV discontinuation |
| In-hospital mortality | up to 24 weeks |
Countries
Italy, Turkey (Türkiye)
Outcome results
None listed