Can High Intensity Inspiratory Muscle Training Improve Inspiratory Muscle Strength and Accelerate Weaning in Medical Patients With Difficulty on Weaning?
Primary Purpose
Weaning Failure
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Low Intensity IMT
High Intensity IMT
Sponsored by
About this trial
This is an interventional treatment trial for Weaning Failure focused on measuring mechanical ventilator weaning, mechanical ventilation, difficult weaning, intensive care unit, inspiratory muscle training, ventilator-induced diaphragmatic dysfunction, physiotherapy
Eligibility Criteria
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.
Sites / Locations
- Hospital Universitari Vall d'Hebron Research Institute
- Hospital Universitari Vall d'Hebron
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Low Intensity IMT
High Intensity IMT
Arm Description
Outcomes
Primary Outcome Measures
Inspiratory muscle strength
Measured with MIP (Maximal Inspiratory Pressure)
Assessments:
Baseline, after the intervention period
Secondary Outcome Measures
Expiratory muscle strength
Measured with MEP (Maximal Expiratory Pressure)
Baseline, after the intervention period
Rapid Shallow Breathing Index
Measured with the mechanical ventilator
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
Weaning success
Recorded as successfully if the patient can breathe spontaneously through tracheostomy without restart mechanical ventilation for at least 48 hours.
Duration of mechanical ventilation
Recorded as the days since patient was connected to mechanical ventilator to successful weaning.
Length of stay in the ICU
Measured in days.
Complications
Defined as the patient needs to be intubated again when the patient was weaned or the death of the participant
Full Information
NCT ID
NCT04347317
First Posted
April 9, 2020
Last Updated
April 16, 2021
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04347317
Brief Title
Can High Intensity Inspiratory Muscle Training Improve Inspiratory Muscle Strength and Accelerate Weaning in Medical Patients With Difficulty on Weaning?
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?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Anticipated)
Primary Completion Date
September 15, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weaning Failure
Keywords
mechanical ventilator weaning, mechanical ventilation, difficult weaning, intensive care unit, inspiratory muscle training, ventilator-induced diaphragmatic dysfunction, physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low Intensity IMT
Arm Type
Active Comparator
Arm Title
High Intensity IMT
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Low Intensity IMT
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
High Intensity IMT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Inspiratory muscle strength
Description
Measured with MIP (Maximal Inspiratory Pressure)
Assessments:
Baseline, after the intervention period
Time Frame
Through study completion, an average of 28 days
Secondary Outcome Measure Information:
Title
Expiratory muscle strength
Description
Measured with MEP (Maximal Expiratory Pressure)
Baseline, after the intervention period
Time Frame
Through study completion, an average of 28 days
Title
Rapid Shallow Breathing Index
Description
Measured with the mechanical ventilator
Time Frame
Through study completion, an average of 28 days
Title
Duration of the weaning period
Description
Defined as the hours since the first attempt of spontaneous breathing (or the initiation of pressure support ≤ 7 cmH2O) to successful weaning
Time Frame
Through study completion, an average of 28 days
Title
Weaning success
Description
Recorded as successfully if the patient can breathe spontaneously through tracheostomy without restart mechanical ventilation for at least 48 hours.
Time Frame
Through study completion, an average of 28 days
Title
Duration of mechanical ventilation
Description
Recorded as the days since patient was connected to mechanical ventilator to successful weaning.
Time Frame
Through study completion, an average of 28 days
Title
Length of stay in the ICU
Description
Measured in days.
Time Frame
Through study completion, an average of 28 days
Title
Complications
Description
Defined as the patient needs to be intubated again when the patient was weaned or the death of the participant
Time Frame
Through study completion, an average of 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esther Batlle Borraz, PT
Phone
+34697964618
Email
esther.batlle.borraz@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bernat Planas Pascual, PT,MSc
Phone
+34934892465
Email
bplanas@vhebron.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernat Planas Pascual, PT,MSc
Organizational Affiliation
Hospital Universitari Vall d'Hebron Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Vall d'Hebron Research Institute
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernat Planas Pascual, PT, MSc
Phone
+34934892465
Email
bplanas@vhebron.net
First Name & Middle Initial & Last Name & Degree
Esther Batlle Borraz, PT
Phone
+34697964618
Email
esther.batlle.borraz@gmail.com
First Name & Middle Initial & Last Name & Degree
Bernat Planas Pascual, PT,MSc
First Name & Middle Initial & Last Name & Degree
Alba Gomez Garrido, MD, PhD
First Name & Middle Initial & Last Name & Degree
Esther Batlle Borraz, PT
First Name & Middle Initial & Last Name & Degree
Alberto Rojo Ruiz, PT
First Name & Middle Initial & Last Name & Degree
Gonzalo Ballesteros Reviriego, PT, MSc
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernat Planas Pascual, MSc
12. IPD Sharing Statement
Plan to Share IPD
No
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Can High Intensity Inspiratory Muscle Training Improve Inspiratory Muscle Strength and Accelerate Weaning in Medical Patients With Difficulty on Weaning?
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