Weaning From Noninvasive Ventilation

Not Applicable

Completed

• Conditions: Hypercapnic Respiratory Failure; Noninvasive Ventilation; Weaning Failure
• Interventions: Other: Protocol for weaning of noninvasive ventilation

• Registration Number: NCT02845076
• Lead Sponsor: Baskent University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-28
• Study First Submitted QC: 2016-07-22
• Study First Posted: 2016-07-27
• Study Start: 2016-09
• Primary Completion: 2020-03
• Study Completion: 2020-03
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-08
• Last Update Posted: 2020-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Decrease in pressure and duration	Protocol for weaning of noninvasive ventilation	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	Protocol for weaning of noninvasive ventilation	Patients will be disconnected from NIV and oxygenated with a nasal cannula. Oxygen flow will be limited to a maximum of 5L/min.
Decrease in duration	Protocol for weaning of noninvasive ventilation	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Rates of intubation	first 5 days of NIV discontinuation
NIV weaning success rates	10 days of NIV discontinuation
Rate of NIV re-institution	10 days of NIV discontinuation
Duration of ICU stay	up to 24 weeks
In-hospital mortality	up to 24 weeks

Trial Locations

Locations (8)

Sureyyapasa Center for Chest Diseases and Thoracic Surgery Training and Investiagation Hospital; 🇹🇷 Istanbul, Turkey

Milan University; 🇮🇹 Milan, Italy

Baskent University; 🇹🇷 Istanbul, Turkey

Marmara University; 🇹🇷 Istanbul, Turkey

San Donato Hospital; 🇮🇹 Arezzo, Italy

Bologna University; 🇮🇹 Bologna, Italy

Dokuz Eylul University; 🇹🇷 İzmir, Turkey

Cukurova University; 🇹🇷 Adana, Turkey