Inspiratory Muscle Training and Nasal High Flow in Difficult Weaning

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-20

Study Completion Date

2021-03-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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High-risk for Reintubation Patients Weaning Outcome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Inspiratory Muscle Training and Nasal High Flow

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

Group Type ACTIVE_COMPARATOR

Inspiratory muscle Training and Nasal High Flow

Intervention Type OTHER

Inspiratory muscle Training will be used to increase respiratory muscle strength. Initial settings will depend on patient's maximal inspiratory pressure. Nasal High Flow will support respiratory muscles and thus reduce the work of breathing. By this mechanism the endurance of the respiratory muscles will increase in parallel with the strenght

Inspiratory Muscle Training and Venturi mask

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

Group Type ACTIVE_COMPARATOR

Inspiratory muscle training and Venturi mask

Intervention Type DEVICE

Inspiratory muscle Training will be used to increase respiratory muscle strength. Initial settings will depend on patient's maximal inspiratory pressure. Venturi mask is usually applied after extubation in every day clinical practice for oxygen supplementation

Interventions

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Inspiratory muscle Training and Nasal High Flow

Inspiratory muscle Training will be used to increase respiratory muscle strength. Initial settings will depend on patient's maximal inspiratory pressure. Nasal High Flow will support respiratory muscles and thus reduce the work of breathing. By this mechanism the endurance of the respiratory muscles will increase in parallel with the strenght

Intervention Type OTHER

Inspiratory muscle training and Venturi mask

Inspiratory muscle Training will be used to increase respiratory muscle strength. Initial settings will depend on patient's maximal inspiratory pressure. Venturi mask is usually applied after extubation in every day clinical practice for oxygen supplementation

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No