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WEANIV: Weaning From Noninvasive Ventilation

Sponsor
Baskent University (Other)
Overall Status
Completed
CT.gov ID
NCT02845076
Collaborator
University of Bologna (Other), Marmara University (Other), Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital (Other), Dokuz Eylul University (Other), Cukurova University (Other), Ospedale San Donato (Other), University of Milan (Other)
197
Enrollment
8
Locations
3
Arms
42
Actual Duration (Months)
24.6
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Protocol for weaning of noninvasive ventilation
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
197 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Weaning From Noninvasive Ventilation
Actual Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Mar 1, 2020
Actual Study Completion Date :
Mar 1, 2020

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Rate of NIV re-institution [10 days of NIV discontinuation]

  2. NIV weaning success rates [10 days of NIV discontinuation]

  3. Duration of ICU stay [up to 24 weeks]

  4. Rates of intubation [first 5 days of NIV discontinuation]

  5. In-hospital mortality [up to 24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 San Donato Hospital Arezzo Italy
2 Bologna University Bologna Italy
3 Milan University Milan Italy
4 Cukurova University Adana Turkey
5 Sureyyapasa Center for Chest Diseases and Thoracic Surgery Training and Investiagation Hospital Istanbul Turkey 34854
6 Baskent University Istanbul Turkey
7 Marmara University Istanbul Turkey
8 Dokuz Eylul University İzmir Turkey

Sponsors and Collaborators

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

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aylin Ozsancak Ugurlu, MD, Baskent University
ClinicalTrials.gov Identifier:
NCT02845076
Other Study ID Numbers:
  • BaskentU
First Posted:
Jul 27, 2016
Last Update Posted:
Jul 10, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Aylin Ozsancak Ugurlu, MD, Baskent University
Noninvasive ventilation
Respiratory insufficiency
Hypercapnia
ventilator weaning
Additional relevant MeSH terms:
Respiratory Insufficiency

Study Results

No Results Posted as of Jul 10, 2020