Can High Intensity Inspiratory Muscle Training Improve Inspiratory Muscle

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04347317
Study type	Interventional
Source	Hospital Universitari Vall d'Hebron Research Institute
Contact	Esther Batlle Borraz, PT
Phone	+34697964618
Email	esther.batlle.borraz@gmail.com
Status	Not yet recruiting
Phase	N/A
Start date	June 1, 2021
Completion date	December 31, 2021

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms