NCT03908658

Inspiratory Muscle Training and Nasal High Flow in Difficult Weaning

The Effectiveness of Inspiratory Muscle Training and Nasal High Flow Oxygen in Difficult Weaning of ICU Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (estimated)
• Sponsor: Evangelismos Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• High-risk for Reintubation Patients
• Weaning Outcome

Interventions

Type	Name	Description
OTHER	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
DEVICE	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

Timeline

• Start date: 2019-03-20
• Primary completion: 2021-01-01
• Completion: 2021-03-20
• First posted: 2019-04-09
• Last updated: 2020-02-12

Locations

1 site across 1 country: Greece