Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02845076
Other study ID # BaskentU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT05539599 - Comprehensive Ultrasound Evaluation as a Predictor of Weaning
Completed NCT01915563 - Rest After Spontaneous Breathing Trial for Prevention of Post-extubation Failure N/A
Recruiting NCT01721434 - Effects of Levosimendan on Diaphragm Function in Mechanically Ventilated Patients Phase 2/Phase 3
Completed NCT01928277 - Weaning From Mechanical Ventilation: Spontaneous Breathing Trial and the Assessment of Work of Breathing N/A
Recruiting NCT05632822 - Value of Diaphragm Function Predicting Weaning From Mechanical Ventilation
Completed NCT06332768 - NIV Versus HFO Versus Standard Therapy Immediately After Weaning From Mechanical Ventilation in ARDS Patients N/A
Completed NCT03240263 - Inspiratory Muscle Training in Difficult to Wean Patients N/A
Completed NCT01867853 - Volume Responsiveness Before SBT Predicts the Outcome of Mechanical Ventilation Weaning in Critically Ill Patients N/A
Recruiting NCT06040138 - Monitoring of Breathing Effort Through Pressure Time Product Measurement Using Airway Occlusion Pressure
Completed NCT06224010 - Respiratory Drive and Inspiratory Effort in COVID-19 Associated ARDS
Completed NCT03129217 - The Validity of Maximal Diaphragm Thickening Fraction to Measure Diaphragm Function in Mechanically Ventilated Patients
Completed NCT05550220 - A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients N/A
Not yet recruiting NCT05431036 - Evaluation of a Combined Model in Predicting Weaning Outcome in Critically Ill Patients.
Recruiting NCT05906888 - Weaning With Tracheostomy - an Observational Study on Patient-centered Outcomes
Recruiting NCT05944588 - Predictive Value of Chest Ultrasound Observation on Extubation Failure
Not yet recruiting NCT05802745 - P0.1 and Extubation Failure in Critically Ill Patients
Recruiting NCT03894189 - The Effect of Doxapram Versus Theophylline on Diaphragmatic Function N/A
Completed NCT01877850 - Utility of a Weaning Protocol in ICU N/A
Completed NCT03580720 - Electromyography for Diaphragm Effort N/A
Recruiting NCT03880864 - Lung Ultrasound for Predicting Outcome of Weaning From Mechanical Ventilation Phase 1