Effects of Respiratory Muscle Training in Mechanically Ventilated Adults

NCT02469064 | Completed Results DMC

• 1 other identifier: 1755
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

Brief Summary

Respiratory muscle training (RMT) is considered a therapeutic strategy to improve respiratory muscle strength in mechanically ventilated (MV) patients and facilitates ventilator weaning. RMT aims at improving strength and endurance of respiratory muscles . However, scarce research exists regarding evaluation of RMT in MV patients and additionally studies differ in methods, RMT protocols and subjects included. There are not reports about Colombian studies evaluating RMT effects on MV patients. The aim of this study is to evaluate the effectiveness of respiratory muscle training in increasing respiratory muscle strength and improving weaning outcomes in MV patients who required ventilatory support for more than 48 hours at an Intensive Care Unit of an IV level Hospital in Cali during the period 2014-2015

Conditions

Respiratory Muscle Weakness

Keywords

mechanical ventilation; respiratory muscle; weaning; training; Intensive care

Outcome Measures

Primary Outcomes (1)

• Weaning Time From Mechanical Ventilation

  Weaning time was considered as time elapsed from beginning of pressure support mode in mechanical ventilation (Pressure support at 10 centimeters of water (cmsH2O) or less) or continuous positive pressure in the airway mode (CPAP) until patient extubation

  Measured by the end of the period of mechanical ventilation, an average expected time of 4 days

Secondary Outcomes (1)

• Changes in Maximum Inspiratory Pressure (MIP)

  Measured at baseline (baseline MIP) and right before patient extubation (finalMIP, an average of 2 hours)

Study Arms (2)

Respiratory Muscle Training

EXPERIMENTAL

Experimental group receives as additional treatment respiratory muscle training.

Other: Respiratory muscle training; Other: Cardiopulmonary Physical Therapy

Conventional physical therapy

ACTIVE COMPARATOR

Conventional Cardiopulmonary Physical Therapy

Other: Cardiopulmonary Physical Therapy

Interventions

Respiratory muscle training OTHER

Respiratory muscle training is done twice every day, with 3 series of 10 repetitions each, with a resting pause of two minutes between series (during resting time, patient is connected to mechanical ventilation again). We adjust initial load for respiratory muscle training as 50% of MIP. At the end of every training session, we assess dyspnea (perceived effort) using Modified Borg Scale (23). Four physical therapists are in charge of Respiratory muscle training, these therapists work at ICU and have experience with critically ill patients.

Respiratory Muscle Training

Cardiopulmonary Physical Therapy OTHER

Control group receives Cardiopulmonary Physical Therapy every 6 hours, physical therapy and mechanical ventilation management

Conventional physical therapy; Respiratory Muscle Training

Eligibility Criteria

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

You may qualify if:

• Age 18 years at least
• Informed consent to participate in study by legal representative or family member
• First event requiring mechanical ventilation
• Being intubated at the study setting ( Valle del Lili Foundation) or at peripheral services and referred 12 hours or less after intubation
• Adequate gas interchange: Blood pressure of oxygen \> 60 mmHg with Inspired fraction of oxygen ≤ 0. 5 and positive pressure at end of expiration (PEEP) \< 8 cmh20
• Sedation level between -1 and 0 (24, 25)
• Hemodynamic stability: Medium arterial blood pressure \> 60 mmHg without vasopressors or requiring a minimum of vasopressor support (epinephrine \< 0,4 mcg/Kg/ min)

You may not qualify if:

• Progressive neuromuscular disease such as Amyotrophic Lateral Sclerosis , Muscular Dystrophy, Multiple Sclerosis, Myasthenia Gravis, or other neuromuscular disorder that could interfere with response to inspiratory muscle training .
• Central nervous system disorders: severe traumatic brain injury
• Spinal cord injury at a level higher than T8
• Chest or spine skeletal disorders (scoliosis, flail chest, spine surgery) that limit movement of ribs and rib cage.
• Requirement of ventilatory support at home prior to hospitalization
• Presence of excessive secretions (requiring more than one suctioning procedure every hour).
• Tracheostomy
• Previous requirement of mechanical ventilation during this period of hospitalization
• Pregnancy

Sponsors & Collaborators

• Fundacion Clinica Valle del Lili: lead
• Universidad del Valle, Colombia: collaborator

Related Publications (12)

• 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

• 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

• 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

• 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

• 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

• 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

• Chang AT, Boots RJ, Henderson R, Paratz JD, Hodges PW. Case report: inspiratory muscle training in chronic critically ill patients--a report of two cases. Physiother Res Int. 2005;10(4):222-6. doi: 10.1002/pri.14.

  PMID: 16411617 BACKGROUND

• American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.

  PMID: 12186831 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

• Chang AT, Boots RJ, Brown MG, Paratz J, Hodges PW. Reduced inspiratory muscle endurance following successful weaning from prolonged mechanical ventilation. Chest. 2005 Aug;128(2):553-9. doi: 10.1378/chest.128.2.553.

  PMID: 16100137 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

• 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 DERIVED

MeSH Terms

Interventions

Breathing Exercises

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Results Point of Contact

• Title: Dr Lina Marcela Sandoval Moreno
• Organization: Universidad del Valle

linamarce48@gmail.com

316 478 0808

Study Officials

• Lina M Sandoval, PT

  Fundacion Valle del Lili- Universidad del Valle

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: June 11, 2015
• Study Start: September 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 12, 2023
• Results First Posted: November 2, 2018

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share