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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
197

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Italy
      • Arezzo, Italy
        • San Donato Hospital
      • Bologna, Italy
        • Bologna University
      • Milan, Italy
        • Milan University
  • Turkey
      • 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
        • Baskent 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Protocol for weaning of noninvasive ventilation
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.
Other: Protocol for weaning of noninvasive ventilation
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.
Other: Protocol for weaning of noninvasive ventilation
3 protocols for weaning of noninvasive ventilation will be compared

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baskent University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Bologna
Cukurova University
Marmara University
Ospedale San Donato
Dokuz Eylul University
University of Milan
Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BaskentU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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