NCT04565002

Brief Summary

Abstract..........................................................................................................04 Introduction....................................................................................................10 Methods.........................................................................................................14 Financial Support...........................................................................................22 References.....................................................................................................24

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 25, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

September 25, 2020

Status Verified

September 1, 2020

Enrollment Period

2.1 years

First QC Date

September 18, 2020

Last Update Submit

September 24, 2020

Conditions

ICU Acquired WeaknessDiaphragmatic Injury

Keywords

transcutaneous electrical diaphragmatic stimulationelderlymechanical ventilationICU acquired weakness

Outcome Measures

Primary Outcomes (1)

  • As a primary endpoint, the change in FDI in EG patients will be considered.

    This index is considered valid to predict success in weaning and extubation, together with other variables.

    18 months

Secondary Outcomes (1)

  • Changes in mechanical ventilation time

    20 months

Study Arms (2)

EG

EXPERIMENTAL

The TEDS protocol will consist of the following parameters: a) frequency of 30 Hz; b) pulse width of 0.4 ms; c) respiratory rate of 15 irpm; d) holding time of 1 s; e) rise time of 1 s; f) 2 s descent time; and g) 2 s non-stimulus time. Phrenics equipment (Dualpex 961, Quark®) will be used. The positioning of the electrodes will be performed according to a study by Cancelliero et al. (2012), who proposed the placement of two electrodes in the right and left paraxiphoid regions, and two others in the direction of the axillary midline, over the seventh intercostal space, also on the right and left sides.

Device: Transcutaneous Electrical Diaphragmatic Stimulation

CG

NO INTERVENTION

The control group will undergo the same assessments as the experimental group, but the TEDS will not be applied.

Interventions

Transcutaneous Electrical Diaphragmatic StimulationDEVICE

The procedure consists of electrical stimulation in the region of the motor points of the diaphragm. Its configurations contribute to produce involuntary muscle contractions. There are four electrodes positioned superficially on the skin.

Also known as: TEDS
EG

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged ≥ 60 years who underwent IMV.

You may not qualify if:

  • Recent surgical scar and/or open lesion in the regions where the electrodes would be placed
  • Severe hemodynamic instability
  • Patient-ventilator asynchrony not reversible with adjustments or optimization of sedation
  • Hypoglycemia \< 60 mg/dL
  • Presence of a cardiac pacemaker
  • Undrained pneumothorax
  • Use of increasing doses of vasoactive drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital e Maternidade Therezinha de Jesus

Juiz de Fora, Minas Gerais, 36025-140, Brazil

RECRUITING

Related Publications (18)

  • 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: 12015377BACKGROUND

  • 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: 12186831RESULT

  • Delerme S, Ray P. Acute respiratory failure in the elderly: diagnosis and prognosis. Age Ageing. 2008 May;37(3):251-7. doi: 10.1093/ageing/afn060. Epub 2008 Apr 3.

    PMID: 18388161RESULT

  • Demoule A, Molinari N, Jung B, Prodanovic H, Chanques G, Matecki S, Mayaux J, Similowski T, Jaber S. Patterns of diaphragm function in critically ill patients receiving prolonged mechanical ventilation: a prospective longitudinal study. Ann Intensive Care. 2016 Dec;6(1):75. doi: 10.1186/s13613-016-0179-8. Epub 2016 Aug 5.

    PMID: 27492005RESULT

  • Desai SV, Law TJ, Needham DM. Long-term complications of critical care. Crit Care Med. 2011 Feb;39(2):371-9. doi: 10.1097/CCM.0b013e3181fd66e5.

    PMID: 20959786RESULT

  • Ferrari G, De Filippi G, Elia F, Panero F, Volpicelli G, Apra F. Diaphragm ultrasound as a new index of discontinuation from mechanical ventilation. Crit Ultrasound J. 2014 Jun 7;6(1):8. doi: 10.1186/2036-7902-6-8. eCollection 2014.

    PMID: 24949192RESULT

  • Gargani L, Volpicelli G. How I do it: lung ultrasound. Cardiovasc Ultrasound. 2014 Jul 4;12:25. doi: 10.1186/1476-7120-12-25.

    PMID: 24993976RESULT

  • Geddes LA, Voorhees WD, Bourland JD, Riscili CE. Optimum stimulus frequency for contracting the inspiratory muscles with chest-surface electrodes to produce artificial respiration. Ann Biomed Eng. 1990;18(1):103-8. doi: 10.1007/BF02368420.

    PMID: 2306029RESULT

  • Goligher EC, Fan E, Herridge MS, Murray A, Vorona S, Brace D, Rittayamai N, Lanys A, Tomlinson G, Singh JM, Bolz SS, Rubenfeld GD, Kavanagh BP, Brochard LJ, Ferguson ND. Evolution of Diaphragm Thickness during Mechanical Ventilation. Impact of Inspiratory Effort. Am J Respir Crit Care Med. 2015 Nov 1;192(9):1080-8. doi: 10.1164/rccm.201503-0620OC.

    PMID: 26167730RESULT

  • Hussain SN, Mofarrahi M, Sigala I, Kim HC, Vassilakopoulos T, Maltais F, Bellenis I, Chaturvedi R, Gottfried SB, Metrakos P, Danialou G, Matecki S, Jaber S, Petrof BJ, Goldberg P. Mechanical ventilation-induced diaphragm disuse in humans triggers autophagy. Am J Respir Crit Care Med. 2010 Dec 1;182(11):1377-86. doi: 10.1164/rccm.201002-0234OC. Epub 2010 Jul 16.

    PMID: 20639440RESULT

  • Kim WY, Lim CM. Ventilator-Induced Diaphragmatic Dysfunction: Diagnosis and Role of Pharmacological Agents. Respir Care. 2017 Nov;62(11):1485-1491. doi: 10.4187/respcare.05622. Epub 2017 Jul 11.

    PMID: 28698263RESULT

  • 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: 18367735RESULT

  • Matamis D, Soilemezi E, Tsagourias M, Akoumianaki E, Dimassi S, Boroli F, Richard JC, Brochard L. Sonographic evaluation of the diaphragm in critically ill patients. Technique and clinical applications. Intensive Care Med. 2013 May;39(5):801-10. doi: 10.1007/s00134-013-2823-1. Epub 2013 Jan 24.

    PMID: 23344830RESULT

  • Radell PJ, Remahl S, Nichols DG, Eriksson LI. Effects of prolonged mechanical ventilation and inactivity on piglet diaphragm function. Intensive Care Med. 2002 Mar;28(3):358-64. doi: 10.1007/s00134-002-1207-8. Epub 2002 Feb 6.

    PMID: 11904668RESULT

  • Umbrello M, Formenti P, Longhi D, Galimberti A, Piva I, Pezzi A, Mistraletti G, Marini JJ, Iapichino G. Diaphragm ultrasound as indicator of respiratory effort in critically ill patients undergoing assisted mechanical ventilation: a pilot clinical study. Crit Care. 2015 Apr 13;19(1):161. doi: 10.1186/s13054-015-0894-9.

    PMID: 25886857RESULT

  • van den Berg M, Hooijman PE, Beishuizen A, de Waard MC, Paul MA, Hartemink KJ, van Hees HWH, Lawlor MW, Brocca L, Bottinelli R, Pellegrino MA, Stienen GJM, Heunks LMA, Wust RCI, Ottenheijm CAC. Diaphragm Atrophy and Weakness in the Absence of Mitochondrial Dysfunction in the Critically Ill. Am J Respir Crit Care Med. 2017 Dec 15;196(12):1544-1558. doi: 10.1164/rccm.201703-0501OC.

    PMID: 28787181RESULT

  • Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.

    PMID: 22392031RESULT

  • Volpicelli G, Mussa A, Garofalo G, Cardinale L, Casoli G, Perotto F, Fava C, Frascisco M. Bedside lung ultrasound in the assessment of alveolar-interstitial syndrome. Am J Emerg Med. 2006 Oct;24(6):689-96. doi: 10.1016/j.ajem.2006.02.013.

    PMID: 16984837RESULT

Central Study Contacts

HEBERT O JUNIOR, MSc

CONTACT

32991301526hebertojr@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The study has a double blind characteristic. Neither the researcher nor the research subject is aware of his group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2020

First Posted

September 25, 2020

Study Start

June 25, 2018

Primary Completion

July 20, 2020

Study Completion

June 30, 2021

Last Updated

September 25, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)