Weaning From Noninvasive Ventilation - Clinical Trial for Hypercapnic Respiratory Failure | NCT02845076

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Protocol for weaning of noninvasive ventilation

About this trial

This is an interventional treatment trial for Hypercapnic Respiratory Failure focused on measuring Noninvasive ventilation, Respiratory insufficiency, Hypercapnia, ventilator weaning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

San Donato Hospital
Bologna University
Milan University
Cukurova University
Sureyyapasa Center for Chest Diseases and Thoracic Surgery Training and Investiagation Hospital
Baskent University
Marmara University
Dokuz Eylul University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Decrease in duration

Decrease in pressure and duration

Abrupt discontinuation of NIV

Arm Description

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.

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.

Patients will be disconnected from NIV and oxygenated with a nasal cannula. Oxygen flow will be limited to a maximum of 5L/min.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rate of NIV re-institution

NIV weaning success rates

Duration of ICU stay

Rates of intubation

In-hospital mortality

Full Information

NCT ID

NCT02845076

First Posted

March 28, 2016

Last Updated

July 8, 2020

Sponsor

Baskent University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02845076

Brief Title

Weaning From Noninvasive Ventilation

Acronym

WEANIV

Official Title

Weaning From Noninvasive Ventilation

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

September 2016 (Actual)

Primary Completion Date

March 2020 (Actual)

Study Completion Date

March 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Baskent University

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercapnic Respiratory Failure, Weaning Failure, Noninvasive Ventilation

Keywords

Noninvasive ventilation, Respiratory insufficiency, Hypercapnia, ventilator weaning

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

197 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Decrease in duration

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Decrease in pressure and duration

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Abrupt discontinuation of NIV

Arm Type

Active Comparator

Arm Description

Patients will be disconnected from NIV and oxygenated with a nasal cannula. Oxygen flow will be limited to a maximum of 5L/min.

Intervention Type

Other

Intervention Name(s)

Protocol for weaning of noninvasive ventilation

Intervention Description

3 protocols for weaning of noninvasive ventilation will be compared

Primary Outcome Measure Information:

Title

The comparison of total duration of NIV after randomization

Description

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.

Time Frame

up to 10 days

Secondary Outcome Measure Information:

Title

Rate of NIV re-institution

Time Frame

10 days of NIV discontinuation

Title

NIV weaning success rates

Time Frame

10 days of NIV discontinuation

Title

Duration of ICU stay

Time Frame

up to 24 weeks

Title

Rates of intubation

Time Frame

first 5 days of NIV discontinuation

Title

In-hospital mortality

Time Frame

up to 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials: