Weaning From Noninvasive Ventilation

Weaning Failure Clinical Trial

— WEANIV  

Official title:

Weaning From Noninvasive Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02845076
• Other study ID #: BaskentU
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: March 2020

Study information

• Verified date: July 2020
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypercapnic Respiratory Failure
• Noninvasive Ventilation
• Respiratory Insufficiency
• Weaning Failure

Intervention

Other:
• Protocol for weaning of noninvasive ventilation
3 protocols for weaning of noninvasive ventilation will be compared

Locations

Country	Name	City	State
Italy	San Donato Hospital	Arezzo
Italy	Bologna University	Bologna
Italy	Milan University	Milan
Turkey	Cukurova University	Adana
Turkey	Baskent University	Istanbul
Turkey	Marmara University	Istanbul
Turkey	Sureyyapasa Center for Chest Diseases and Thoracic Surgery Training and Investiagation Hospital	Istanbul
Turkey	Dokuz Eylul University	Izmir

Sponsors (8)

Lead Sponsor	Collaborator
Baskent University	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

Countries where clinical trial is conducted

Italy,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of NIV re-institution		10 days of NIV discontinuation
Secondary	NIV weaning success rates		10 days of NIV discontinuation
Secondary	Duration of ICU stay		up to 24 weeks
Secondary	Rates of intubation		first 5 days of NIV discontinuation
Secondary	In-hospital mortality		up to 24 weeks