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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Intensity IMT | Active Comparator |
| |
| High Intensity IMT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Intensity IMT | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Inspiratory muscle strength | Measured with MIP (Maximal Inspiratory Pressure) Assessments: Baseline, after the intervention period | Through study completion, an average of 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Expiratory muscle strength | Measured with MEP (Maximal Expiratory Pressure) Baseline, after the intervention period | Through study completion, an average of 28 days |
| Rapid Shallow Breathing Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esther Batlle Borraz, PT | Contact | +34697964618 | esther.batlle.borraz@gmail.com | |
| Bernat Planas Pascual, PT,MSc | Contact | +34934892465 | bplanas@vhebron.net |
| Name | Affiliation | Role |
|---|---|---|
| Bernat Planas Pascual, PT,MSc | Hospital Universitari Vall d'Hebron Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Vall d'Hebron Research Institute | Barcelona | 08035 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Dixit A, Prakash S. Effects of threshold inspiratory muscle training versus conventional physiotherapy on the weaning period of mechanically ventilated patients: a comparative study. Int J Physiother Res. 2014;2(2):424-8 | ||
| 22093119 | Background | Moodie L, Reeve J, Elkins M. Inspiratory muscle training increases inspiratory muscle strength in patients weaning from mechanical ventilation: a systematic review. J Physiother. 2011;57(4):213-21. doi: 10.1016/S1836-9553(11)70051-0. | |
| 26365266 |
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| High Intensity IMT | Procedure | 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. |
|
Measured with the mechanical ventilator
| Through study completion, an average of 28 days |
| Duration of the weaning period | Defined as the hours since the first attempt of spontaneous breathing (or the initiation of pressure support ≤ 7 cmH2O) to successful weaning | Through study completion, an average of 28 days |
| Weaning success | Recorded as successfully if the patient can breathe spontaneously through tracheostomy without restart mechanical ventilation for at least 48 hours. | Through study completion, an average of 28 days |
| Duration of mechanical ventilation | Recorded as the days since patient was connected to mechanical ventilator to successful weaning. | Through study completion, an average of 28 days |
| Length of stay in the ICU | Measured in days. | Through study completion, an average of 28 days |
| Complications | Defined as the patient needs to be intubated again when the patient was weaned or the death of the participant | Through study completion, an average of 28 days |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
|
| Background |
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