NCT04347317

Can High Intensity Inspiratory Muscle Training Improve Inspiratory Muscle Strength and Accelerate Weaning in Medical Patients With Difficulty on Weaning?

Can High Intensity Inspiratory Muscle Training Improve Inspiratory Muscle Strength and Accelerate Weaning in Medical Patients With Difficulty on Weaning Admitted in the Intensive Care Unit?

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Introduction: It has been described that invasive mechanical ventilation leads to diaphragm weakness. The inspiratory muscle weakness is related with a difficult and prolonged weaning as well as longer duration of mechanical ventilation and increased risk of complications and death. Consequently, the duration of stay in ICU is longer and the costs in ICU increase. Objectives: To determine the effects of a high intensity inspiratory muscle training (IMT) on inspiratory muscle strength, weaning outcomes, complications and length of stay in the ICU in medical patients with difficulty on weaning and admitted in the ICU. Methodology: In a single blind randomized clinical trial, 40 tracheotomy ventilated medical patients in which spontaneous breathing trial has failed ≥ 1 time, will be selected and randomized into two equitable groups. In the intervention group, IMT will be performed at 60% of the maximum inspiratory pressure (which will increase by 10% every week) while in the control group it will be performed at 30%. In both groups, 5 sets of 6 breaths will be performed, once a day, 5 days a week, for a maximum of 28 days or until the patient is successfully weaned. The main outcome will be the maximum inspiratory pressure, while the maximum expiratory pressure, weaning duration process, weaning success, duration of mechanical ventilation, length of stay in the ICU, complications and the rapid shallow breathing index will be analyzed as secondary outcomes. t-student test for independent samples will be used to analyze quantitative outcomes. For qualitative outcomes will be used X2 test. A value of p\<0.05 will be assumed as an indicator of statistically significant results. Future contributions: Our collect results can be useful for the updating of the clinical practice guidelines and promote its implementation in the clinical practice.

Conditions

• Weaning Failure

Interventions

Type	Name	Description
PROCEDURE	Low Intensity IMT	The control group will get a supervised IMT with Threshold IMT device, once a day, 5 days a week for a maximum of 28 days or until the participant is weaned successfully. In each session the participant will do 5 sets of 6 repetitions with 2 minutes of rest between sets. The initial training load will be adjusted to 30% of the MIP and will be increased by 10% of the initial MIP weekly. The patient will be placed in a semi-incorporated position (head of the bed elevated 45º). The ICU physiotherapist will check before training that the cuff of the tracheal tube is correctly swollen to avoid air leaks during the training. The ICU physiotherapist will disconnect the mechanical ventilation during the IMT and will provide supplemental oxygen when required. However, between series the participant will be returned to ventilator support. Patients will be instructed to do a whole expiration and immediately inspire as forceful as possible until reaching the total lung capacity.
PROCEDURE	High Intensity IMT	The experimental group will get a supervised IMT with Threshold IMT device, once a day, 5 days a week for a maximum of 28 days or until the participant is weaned successfully. In each session the participant will do 5 sets of 6 repetitions with 2 minutes of rest between sets. The initial training load will be adjusted to 60% of the MIP and will be increased by 10% of the initial MIP weekly. The patient will be placed in a semi-incorporated position (head of the bed elevated 45º). The ICU physiotherapist will check before training that the cuff of the tracheal tube is correctly swollen to avoid air leaks during the training. The ICU physiotherapist will disconnect the mechanical ventilation during the IMT and will provide supplemental oxygen when required. However, between series the participant will be returned to ventilator support. Patients will be instructed to do a whole expiration and immediately inspire as forceful as possible until reaching the total lung capacity.

Timeline

• Start date: 2021-06-01
• Primary completion: 2021-09-15
• Completion: 2021-12-31
• First posted: 2020-04-15
• Last updated: 2021-04-19

Locations

2 sites across 1 country: Spain