Weaning From Noninvasive Ventilation (WEANIV)

Baskent University

Status: Completed

Conditions: Weaning Failure; Noninvasive Ventilation; Hypercapnic Respiratory Failure

Treatments: Other: Protocol for weaning of noninvasive ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT02845076

BaskentU

Details and patient eligibility

About

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.

Enrollment: 197 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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197 participants in 3 patient groups

Decrease in duration

Active Comparator group

Description:

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.

Treatment:

Other: Protocol for weaning of noninvasive ventilation

Decrease in pressure and duration

Active Comparator group

Description:

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.

Treatment:

Other: Protocol for weaning of noninvasive ventilation

Abrupt discontinuation of NIV

Active Comparator group

Description:

Patients will be disconnected from NIV and oxygenated with a nasal cannula. Oxygen flow will be limited to a maximum of 5L/min.

Treatment:

Other: Protocol for weaning of noninvasive ventilation