Weaning From Noninvasive Ventilation (WEANIV)

July 8, 2020 updated by: Aylin Ozsancak Ugurlu, Baskent University
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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

197

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Arezzo, Italy
        • San Donato Hospital
      • Bologna, Italy
        • Bologna University
      • Milan, Italy
        • Milan University
      • Adana, Turkey
        • Cukurova University
      • Istanbul, Turkey
        • Marmara University
      • Istanbul, Turkey, 34854
        • Sureyyapasa Center for Chest Diseases and Thoracic Surgery Training and Investiagation Hospital
      • Istanbul, Turkey
        • Başkent University
      • İzmir, Turkey
        • Dokuz Eylul University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Decrease in duration
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.
3 protocols for weaning of noninvasive ventilation will be compared
ACTIVE_COMPARATOR: Decrease in pressure and duration
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.
3 protocols for weaning of noninvasive ventilation will be compared
ACTIVE_COMPARATOR: Abrupt discontinuation of NIV
Patients will be disconnected from NIV and oxygenated with a nasal cannula. Oxygen flow will be limited to a maximum of 5L/min.
3 protocols for weaning of noninvasive ventilation will be compared

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The comparison of total duration of NIV after randomization
Time Frame: 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.
up to 10 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Stefano Nava, Bologna University
  • Study Director: Begum Ergan, Dokuz Eylul University
  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2016

Primary Completion (ACTUAL)

March 1, 2020

Study Completion (ACTUAL)

March 1, 2020

Study Registration Dates

First Submitted

March 28, 2016

First Submitted That Met QC Criteria

July 22, 2016

First Posted (ESTIMATE)

July 27, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 10, 2020

Last Update Submitted That Met QC Criteria

July 8, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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