Weaning From Noninvasive Ventilation

Study Overview
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Brief Summary
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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.

Official Title
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Weaning From Noninvasive Ventilation

Conditions
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Hypercapnic Respiratory Failure, Weaning Failure, Noninvasive Ventilation

Intervention / Treatment
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* Other: Protocol for weaning of noninvasive ventilation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Decrease in duration<br>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. | Other: Protocol for weaning of noninvasive ventilation<br>* 3 protocols for weaning of noninvasive ventilation will be compared<br>|
| Active Comparator: Decrease in pressure and duration<br>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. | Other: Protocol for weaning of noninvasive ventilation<br>* 3 protocols for weaning of noninvasive ventilation will be compared<br>|
| Active Comparator: Abrupt discontinuation of NIV<br>Patients will be disconnected from NIV and oxygenated with a nasal cannula. Oxygen flow will be limited to a maximum of 5L/min. | Other: Protocol for weaning of noninvasive ventilation<br>* 3 protocols for weaning of noninvasive ventilation will be compared<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 10 days | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | up to 24 weeks | 
| Rates of intubation |  | first 5 days of NIV discontinuation | 
| In-hospital mortality |  | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Noninvasive ventilation, Respiratory insufficiency, Hypercapnia, ventilator weaning