Inspiratory Muscle Training and Nasal High Flow in Difficult Weaning

Evangelismos Hospital

Status: Unknown

Conditions: Weaning Outcome; High-risk for Reintubation Patients

Treatments: Other: Inspiratory muscle Training and Nasal High Flow; Device: Inspiratory muscle training and Venturi mask

Study type: Interventional

Funder types: Other

Identifiers

NCT03908658

6345/14-03-2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 146 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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146 participants in 2 patient groups

Inspiratory Muscle Training and Nasal High Flow

Active Comparator group

Description:

Inspiratory Muscle Training will start as soon as the patient wakes up and is cooperative, ventilated with support settings. Nasal High Flow will be applied immediately after extubation. IMT intervention will continue until patient's discharge from the ICU

Treatment:

Other: Inspiratory muscle Training and Nasal High Flow

Inspiratory Muscle Training and Venturi mask

Active Comparator group

Description:

IMT will start as soon as the patient wakes up and is cooperative, ventilated with support settings. Venturi mask will be applied immediately after extubation. IMT intervention will continue until patient's discharge from the ICU

Treatment:

Device: Inspiratory muscle training and Venturi mask