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Completed

NCT Number: NCT02845076

Weaning From Noninvasive Ventilation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Donato Hospital, Arezzo, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protocol for weaning of noninvasive ventilation

Other

3 protocols for weaning of noninvasive ventilation will be compared

Primary outcomes

  1. 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.

Secondary outcomes

  1. Rate of NIV re-institution

    Time frame: 10 days of NIV discontinuation

  2. NIV weaning success rates

    Time frame: 10 days of NIV discontinuation

  3. Duration of ICU stay

    Time frame: up to 24 weeks

  4. Rates of intubation

    Time frame: first 5 days of NIV discontinuation

  5. In-hospital mortality

    Time frame: up to 24 weeks

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Collaborators

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

Registry information

Acronym: WEANIV

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jul 27, 2016
Registry last updated
Jul 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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