Weaning From Noninvasive Ventilation

NCT02845076 | Completed DMC

• 1 other identifier: BaskentU
• Study Type: interventional
• Target: 197
• Locations: 2 countries
• Sites: 8

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.

Conditions

Hypercapnic Respiratory Failure; Weaning Failure; Noninvasive Ventilation

Keywords

Noninvasive ventilation; Respiratory insufficiency; Hypercapnia; ventilator weaning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (3)

Decrease in duration

ACTIVE COMPARATOR

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

Decrease in pressure and duration

ACTIVE COMPARATOR

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

Abrupt discontinuation of NIV

ACTIVE COMPARATOR

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

Interventions

Protocol for weaning of noninvasive ventilation OTHER

3 protocols for weaning of noninvasive ventilation will be compared

Abrupt discontinuation of NIV; Decrease in duration; Decrease in pressure and duration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• % 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baskent University: lead
• University of Bologna: collaborator
• Marmara University: collaborator
• Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital: collaborator
• Dokuz Eylul University: collaborator
• Cukurova University: collaborator
• Ospedale San Donato: collaborator
• University of Milan: collaborator

Study Sites (8)

San Donato Hospital

Arezzo, Italy

Location

Bologna University

Bologna, Italy

Location

Milan University

Milan, Italy

Location

Cukurova University

Adana, Turkey (Türkiye)

Location

Sureyyapasa Center for Chest Diseases and Thoracic Surgery Training and Investiagation Hospital

Istanbul, 34854, Turkey (Türkiye)

Location

Baskent University

Istanbul, Turkey (Türkiye)

Location

Marmara University

Istanbul, Turkey (Türkiye)

Location

Dokuz Eylul University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Hypercapnia

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Stefano Nava

  Bologna University

  STUDY CHAIR

• Begum Ergan

  Dokuz Eylul University

  STUDY DIRECTOR

• Sait Karakurt

  Marmara University

  PRINCIPAL INVESTIGATOR

• Ezgi Ozyılmaz

  Cukurova University

  PRINCIPAL INVESTIGATOR

• Raffaele Scala

  San Donato Hospital

  PRINCIPAL INVESTIGATOR

• Fabiano Di Marco

  Milan University

  PRINCIPAL INVESTIGATOR

• Zuhal Karakurt

  Sureyyapasa Center for Chest Diseases and Thoracic Surgery Training and Investiagation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 28, 2016
• First Posted: July 27, 2016
• Study Start: September 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: July 10, 2020

Record last verified: 2020-07

Locations

TU (5); IT (3)