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

Weaning Failure Clinical Trial

Official title:

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?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04347317
• Other study ID #: PR(ATR)03/2020
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2021
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Esther Batlle Borraz, PT
• Phone: +34697964618
• Email: esther.batlle.borraz[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Medical patients aged = 18 years hospitalized in the ICU.

• Patients ventilated by tracheostomy and who have failed = 1 spontaneous breathing test.

• Being ventilated in assisted-controlled, assisted or pressure support modes.

• PEEP = 10 cmH2O

• Richmond Agitation-Sedation Scale between -1 and 0.

• Confusion Assessment Method for the Intensive Care Unit negative.

• Cardiorespiratory and hemodynamic stability in the absence of vasopressor support or with minimal requirement (dobutamine or dopamine = 5 µg / kg / min, phenylephrine = 1 µg / kg / min).

• FiO2 = 0,6

• PaO2/FiO2 ratio > 200

• Blood lactate levels < 4 mmol/L

Exclusion Criteria:

• Progressive neuromuscular disease

• Thoraco-abdominal surgery in a period <30 days from the beginning of the study.

• Diseases that cause hemodynamic instability (cardiac arrhythmia, decompensated heart failure, unstable ischemic heart disease).

• Hemoptysis

• Unstable chest wall.

• Not drained pneumothorax

• Phrenic nerve injury

• Spinal cord injury above T8

• Clinical signs of respiratory distress (paradoxal breathing, use of accessory respiratory muscles)

• Body mass index > 40 kg / m2

• Use domiciliary ventilator support prior to hospitalization.

• Skeletal disorder of the rib cage that impairs its biomechanics (severe kyphoscoliosis, congenital deformities).

• Body temperature > 38ºC

• Pregnancy

• Receive therapy with nitric oxide or nebulized prostacyclin.

• Medical order.

Related Conditions & MeSH terms

• Respiratory Aspiration
• Weaning Failure

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitari Vall d'Hebron Research Institute	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (26)

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inspiratory muscle strength	Measured with MIP (Maximal Inspiratory Pressure); Assessments: Baseline, after the intervention period	Through study completion, an average of 28 days
Secondary	Expiratory muscle strength	Measured with MEP (Maximal Expiratory Pressure); Baseline, after the intervention period	Through study completion, an average of 28 days
Secondary	Rapid Shallow Breathing Index	Measured with the mechanical ventilator	Through study completion, an average of 28 days
Secondary	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
Secondary	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
Secondary	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
Secondary	Length of stay in the ICU	Measured in days.	Through study completion, an average of 28 days
Secondary	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