Clinical trial NCT03908658: Inspiratory Muscle Training and Nasal High Flow in Difficult Weaning
Official title: The Effectiveness of Inspiratory Muscle Training and Nasal High Flow Oxygen in Difficult Weaning of ICU Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: High-risk for Reintubation Patients
Weaning Outcome
Keywords: inspiratory muscle training
Nasal High Flow
Lead sponsor: Evangelismos Hospital
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the present study is to investigate the effectiveness of inspiratory muscle training and nasal high flow oxygen in patients with difficult weaning and high-risk for re-intubation. The hypothesis of the study is that starting inspiratory muscle training once patients are awake and co-operative along with the application of nasal high flow oxygen immediately after extubation will have a beneficial effect in preventive re-intubation in these high-risk patients.

Detailed description: 20-30% of intubated patients are difficult to be weaned off the mechanical ventilation and have a prolonged ICU stay. It is well established that prolonged ICU stay is associated with reduced muscle strength, functional ability and quality of life.

Inspiratory muscle training (IMT) via a threshold device has been proposed as an effective exercise for minimizing the detrimental effect of mechanical ventilation in critical ill patients with prolonged weaning. Additionally, Nasal High Flow (NHF) oxygen has been proved to support efficiently either high or low-risk patients after extubation and thus preventing re-intubation.

A randomized intervention study was designed to assess the efficacy of combining IMT and NHF as therapeutic strategies for difficult weaning. Once patients with prognostic factors of difficult weaning are awake and co-operative they will be randomized to one of the two following study groups: 1) IMT and NHF group, 2) IMT and Venturi mask group. IMT will start as soon as the patient wakes up and is cooperative, ventilated with support settings. Each allocated oxygen delivery device will be applied immediately after extubation. IMT intervention will continue until patients' discharge from the ICU.

Eligibility criteria: Inclusion Criteria:

* \>65 years,
* BMI\> 35kg/m2,
* weak cough,
* heart (i.e heart failure ) and lung comorbidities (i.e COPD),
* hypercapnia during mechanical ventilation
* \> 72hours on mechanical ventilation
* failed first spontaneous breathing trial

Exclusion Criteria:

* Glasgow Coma scale (GCS)\<13,
* pre-existing neuromuscular disease or deformity of Spinal Cord,
* terminal disease
* hemodynamic instability with \>0.1μg/kg/min noradrenaline
* patients of immediately need of Non-invasive ventilation after extubation

Primary outcomes:
measure: Rate of weaning failure
timeFrame: 48 hours after extubation
Secondary outcomes:
measure: Maximal Inspiratory Pressure
timeFrame: Within 2 hours after patient randomization, within 24 hours after extubation, within 24 hours after ICU discharge
measure: Maximal Expiratory Pressure
timeFrame: Within 2 hours after patient randomization, within 24 hours after extubation, within 24 hours after ICU discharge
measure: Endurance of respiratory muscles
timeFrame: Within 2 hours after patient randomization, within 24 hours after extubation , within 24 hours after ICU discharge
measure: Muscle strenght
timeFrame: Within 2 hours after patient randomization, within 24 hours after ICU discharge, within 24 hours before hospital discharge
measure: Functional ability
timeFrame: Within 24 hours after ICU discharge, within 24 hours before hospital discharge
measure: Short Form 36 Health Survey (SF-36) questionnaire
timeFrame: Within 24 hours before hospital discharge
measure: Euro-Qol 5 Dimensions 5 Level of severity scale (Euro-Qol 5D-5L scale)
timeFrame: Within 24 hours before hospital discharge
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Evangelismos Hospital
Study officials:
References: