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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
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 9, 2020
Last Updated
April 16, 2021
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
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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
Citations:
Citation
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
Results Reference
background
PubMed Identifier
22093119
Citation
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.
Results Reference
background
PubMed Identifier
26365266
Citation
Bonnevie T, Villiot-Danger JC, Gravier FE, Dupuis J, Prieur G, Medrinal C. Inspiratory muscle training is used in some intensive care units, but many training methods have uncertain efficacy: a survey of French physiotherapists. J Physiother. 2015 Oct;61(4):204-9. doi: 10.1016/j.jphys.2015.08.003. Epub 2015 Sep 11.
Results Reference
background
PubMed Identifier
30007823
Citation
Bissett B, Leditschke IA, Green M, Marzano V, Collins S, Van Haren F. Inspiratory muscle training for intensive care patients: A multidisciplinary practical guide for clinicians. Aust Crit Care. 2019 May;32(3):249-255. doi: 10.1016/j.aucc.2018.06.001. Epub 2018 Jul 11.
Results Reference
background
PubMed Identifier
29038671
Citation
Tonella RM, Ratti LDSR, Delazari LEB, Junior CF, Da Silva PL, Herran ARDS, Dos Santos Faez DC, Saad IAB, De Figueiredo LC, Moreno R, Dragosvac D, Falcao ALE. Inspiratory Muscle Training in the Intensive Care Unit: A New Perspective. J Clin Med Res. 2017 Nov;9(11):929-934. doi: 10.14740/jocmr3169w. Epub 2017 Oct 2.
Results Reference
background
PubMed Identifier
23663795
Citation
Condessa RL, Brauner JS, Saul AL, Baptista M, Silva AC, Vieira SR. Inspiratory muscle training did not accelerate weaning from mechanical ventilation but did improve tidal volume and maximal respiratory pressures: a randomised trial. J Physiother. 2013 Jun;59(2):101-7. doi: 10.1016/S1836-9553(13)70162-0.
Results Reference
background
PubMed Identifier
22340987
Citation
Bissett B, Leditschke IA, Green M. Specific inspiratory muscle training is safe in selected patients who are ventilator-dependent: a case series. Intensive Crit Care Nurs. 2012 Apr;28(2):98-104. doi: 10.1016/j.iccn.2012.01.003. Epub 2012 Feb 15.
Results Reference
background
PubMed Identifier
12015377
Citation
Sassoon CS, Caiozzo VJ, Manka A, Sieck GC. Altered diaphragm contractile properties with controlled mechanical ventilation. J Appl Physiol (1985). 2002 Jun;92(6):2585-95. doi: 10.1152/japplphysiol.01213.2001.
Results Reference
background
PubMed Identifier
18367735
Citation
Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.
Results Reference
background
PubMed Identifier
22425820
Citation
Hudson MB, Smuder AJ, Nelson WB, Bruells CS, Levine S, Powers SK. Both high level pressure support ventilation and controlled mechanical ventilation induce diaphragm dysfunction and atrophy. Crit Care Med. 2012 Apr;40(4):1254-60. doi: 10.1097/CCM.0b013e31823c8cc9.
Results Reference
background
Citation
Silva PE. Inspiratory muscle training in mechanical ventilation: suitable protocols and endpoints, the key to clear results - a critical review. ASSOBRAFIR Ciência. 2015;6(1):21-30
Results Reference
background
Citation
Elbouhy MS, AbdelHalim HA, Hashem AMA. Effect of respiratory muscles training in weaning of mechanically ventilated COPD patients. Egypt J Chest Dis Tuberc. 2014;63(3):679-87
Results Reference
background
PubMed Identifier
17933168
Citation
Bissett B, Leditschke IA. Inspiratory muscle training to enhance weaning from mechanical ventilation. Anaesth Intensive Care. 2007 Oct;35(5):776-9. doi: 10.1177/0310057X0703500520.
Results Reference
background
PubMed Identifier
12564952
Citation
Sprague SS, Hopkins PD. Use of inspiratory strength training to wean six patients who were ventilator-dependent. Phys Ther. 2003 Feb;83(2):171-81.
Results Reference
background
PubMed Identifier
20795923
Citation
Cader SA, Vale RG, Castro JC, Bacelar SC, Biehl C, Gomes MC, Cabrer WE, Dantas EH. Inspiratory muscle training improves maximal inspiratory pressure and may assist weaning in older intubated patients: a randomised trial. J Physiother. 2010;56(3):171-7. doi: 10.1016/s1836-9553(10)70022-9.
Results Reference
background
Citation
Hernández-López GH; Cerón-Juárez R; Escobar-Ortiz D; Graciano-Gaytán L; Gorordo-Delsol LA; Merinos-Sánchez G; Castañón-González JA; Amezcua-Gutiérrez MA; Cruz-Montesinos S; Garduño-López J; Lima-Lucero IM; Montoya-Rojo JO. Retiro de la ventilación mecánica. Med Crit. 2017;31(4):238-45
Results Reference
background
PubMed Identifier
29398169
Citation
Sandoval Moreno LM, Casas Quiroga IC, Wilches Luna EC, Garcia AF. Efficacy of respiratory muscle training in weaning of mechanical ventilation in patients with mechanical ventilation for 48hours or more: A Randomized Controlled Clinical Trial. Med Intensiva (Engl Ed). 2019 Mar;43(2):79-89. doi: 10.1016/j.medin.2017.11.010. Epub 2018 Feb 3. English, Spanish.
Results Reference
background
PubMed Identifier
27475524
Citation
Medrinal C, Prieur G, Frenoy E, Robledo Quesada A, Poncet A, Bonnevie T, Gravier FE, Lamia B, Contal O. Respiratory weakness after mechanical ventilation is associated with one-year mortality - a prospective study. Crit Care. 2016 Jul 31;20(1):231. doi: 10.1186/s13054-016-1418-y.
Results Reference
background
PubMed Identifier
12114357
Citation
Martin AD, Davenport PD, Franceschi AC, Harman E. Use of inspiratory muscle strength training to facilitate ventilator weaning: a series of 10 consecutive patients. Chest. 2002 Jul;122(1):192-6. doi: 10.1378/chest.122.1.192.
Results Reference
background
PubMed Identifier
29584447
Citation
Vorona S, Sabatini U, Al-Maqbali S, Bertoni M, Dres M, Bissett B, Van Haren F, Martin AD, Urrea C, Brace D, Parotto M, Herridge MS, Adhikari NKJ, Fan E, Melo LT, Reid WD, Brochard LJ, Ferguson ND, Goligher EC. Inspiratory Muscle Rehabilitation in Critically Ill Adults. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2018 Jun;15(6):735-744. doi: 10.1513/AnnalsATS.201712-961OC.
Results Reference
background
PubMed Identifier
16358138
Citation
Caruso P, Denari SD, Ruiz SA, Bernal KG, Manfrin GM, Friedrich C, Deheinzelin D. Inspiratory muscle training is ineffective in mechanically ventilated critically ill patients. Clinics (Sao Paulo). 2005 Dec;60(6):479-84. doi: 10.1590/s1807-59322005000600009. Epub 2005 Dec 12.
Results Reference
background
Citation
Mohamed AR, El Basiouny HMS, Salem NM. Response of Mechanically Ventilated Respiratory Failure Patients to Respiratory Muscles Training. Med J Cairo Univ. 2014;82(1):19-24
Results Reference
background
Citation
Ibrahiem AA;, Mohamed AR;, Saber HM; Effect Of Respiratory Muscles Training In Addition To Standard Chest Physiotherapy On Mechanically Ventilated Patients. J Med Res Pract. 2014;3(3):52-8
Results Reference
background
PubMed Identifier
21385346
Citation
Martin AD, Smith BK, Davenport PD, Harman E, Gonzalez-Rothi RJ, Baz M, Layon AJ, Banner MJ, Caruso LJ, Deoghare H, Huang TT, Gabrielli A. Inspiratory muscle strength training improves weaning outcome in failure to wean patients: a randomized trial. Crit Care. 2011;15(2):R84. doi: 10.1186/cc10081. Epub 2011 Mar 7.
Results Reference
background
PubMed Identifier
16996322
Citation
Downey AE, Chenoweth LM, Townsend DK, Ranum JD, Ferguson CS, Harms CA. Effects of inspiratory muscle training on exercise responses in normoxia and hypoxia. Respir Physiol Neurobiol. 2007 May 14;156(2):137-46. doi: 10.1016/j.resp.2006.08.006. Epub 2006 Sep 22.
Results Reference
background
PubMed Identifier
27762595
Citation
Girard TD, Alhazzani W, Kress JP, Ouellette DR, Schmidt GA, Truwit JD, Burns SM, Epstein SK, Esteban A, Fan E, Ferrer M, Fraser GL, Gong MN, Hough CL, Mehta S, Nanchal R, Patel S, Pawlik AJ, Schweickert WD, Sessler CN, Strom T, Wilson KC, Morris PE; ATS/CHEST Ad Hoc Committee on Liberation from Mechanical Ventilation in Adults. An Official American Thoracic Society/American College of Chest Physicians Clinical Practice Guideline: Liberation from Mechanical Ventilation in Critically Ill Adults. Rehabilitation Protocols, Ventilator Liberation Protocols, and Cuff Leak Tests. Am J Respir Crit Care Med. 2017 Jan 1;195(1):120-133. doi: 10.1164/rccm.201610-2075ST.
Results Reference
background

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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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