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

NCT04347317 | Unknown DMC

• 1 other identifier: PR(ATR)03/2020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Weaning Failure

Keywords

mechanical ventilator weaning; mechanical ventilation; difficult weaning; intensive care unit; inspiratory muscle training; ventilator-induced diaphragmatic dysfunction; physiotherapy

Outcome Measures

Primary Outcomes (1)

• Inspiratory muscle strength

  Measured with MIP (Maximal Inspiratory Pressure) Assessments: Baseline, after the intervention period

  Through study completion, an average of 28 days

Secondary Outcomes (7)

• Expiratory muscle strength

  Through study completion, an average of 28 days

• Rapid Shallow Breathing Index

  Through study completion, an average of 28 days

• Duration of the weaning period

  Through study completion, an average of 28 days

• Weaning success

  Through study completion, an average of 28 days

• Duration of mechanical ventilation

  Through study completion, an average of 28 days

Study Arms (2)

Low Intensity IMT

ACTIVE COMPARATOR

Procedure: Low Intensity IMT

High Intensity IMT

EXPERIMENTAL

Procedure: High Intensity IMT

Interventions

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.

Low Intensity IMT

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.

High Intensity IMT

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (2)

Hospital Universitari Vall d'Hebron Research Institute

Barcelona, 08035, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Related Publications (26)

• 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

  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.

  PMID: 22093119 BACKGROUND

• 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.

  PMID: 26365266 BACKGROUND

• 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.

  PMID: 30007823 BACKGROUND

• 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.

  PMID: 29038671 BACKGROUND

• 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.

  PMID: 23663795 BACKGROUND

• 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.

  PMID: 22340987 BACKGROUND

• 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.

  PMID: 12015377 BACKGROUND

• 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.

  PMID: 18367735 BACKGROUND

• 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.

  PMID: 22425820 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 17933168 BACKGROUND

• 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.

  PMID: 12564952 BACKGROUND

• 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.

  PMID: 20795923 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 29398169 BACKGROUND

• 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.

  PMID: 27475524 BACKGROUND

• 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.

  PMID: 12114357 BACKGROUND

• 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.

  PMID: 29584447 BACKGROUND

• 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.

  PMID: 16358138 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 21385346 BACKGROUND

• 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.

  PMID: 16996322 BACKGROUND

• 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.

  PMID: 27762595 BACKGROUND

Study Officials

• Bernat Planas Pascual, PT,MSc

  Hospital Universitari Vall d'Hebron Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esther Batlle Borraz, PT

CONTACT

+34697964618; esther.batlle.borraz@gmail.com

Bernat Planas Pascual, PT,MSc

CONTACT

+34934892465; bplanas@vhebron.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 15, 2020
• Study Start: June 1, 2021
• Primary Completion: September 15, 2021
• Study Completion: December 31, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)