Analysis of the Magnetic Tape Bandage on Respiratory Functional Effects.

NCT05356299 | Unknown

• 1 other identifier: 123/20
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Invasive mechanical ventilation (IMV) is the mainstay of supportive care in acute respiratory failure. However, maintaining ventilatory support beyond what is necessary may increase the risk of nosocomial infections, favour respiratory muscle atrophy, prolong ICU stay and increase hospital costs. Similarly, premature withdrawal of ventilatory support may increase ICU patient mortality by requiring reintubation. The MV weaning process is nothing more than the set of procedures that lead to the restoration of normal ventilation of the patient, freeing him/her from ventilatory support and eventually also from an artificial airway. This is a gradual process that can take a significant amount of hospitalisation time, so much so that it could even correspond to 40% of the entire period of ventilatory support. Currently, the process of disconnection from IMV is based on the performance of a spontaneous ventilation test (SVT) either with an unsupported oxygen source or with low ventilator support , with a duration of 30 to 120 minutes. One of the causes that may condition the viability of SVT is respiratory muscle weakness, which may be ventilator-induced. This condition is a syndrome characterised by the appearance of diffuse and symmetrical muscle weakness affecting 26-65% of patients mechanically ventilated for more than 5 days. Muscle wasting has been demonstrated by ultrasonography with an 18% reduction in the cross-sectional area of the rectus femoris muscle on the 10th day of evolution. This syndrome is associated with an increase in mechanical ventilation time and a 2 to 5-fold increase in mortality. Based on the above, the assessment of respiratory muscle strength should form part of the disconnection protocols of our units. The most studied parameters that provide us with information on patient readiness to face this process are f/Vt, PIM and P(O.1). Recently, the study of the diaphragm by ultrasonography is becoming a valid alternative technique for the study of the state of the muscle most involved in spontaneous breathing.

Conditions

Airway Extubation

Keywords

Airway extubation failure; Magnetictape; Invasive mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Peak Inspiratory Pressure

  The measurement will be performed using the ventilator software (Puritan Bennett 980 / 840, Medtronic, Dublin Ireland). Change from Baseline Peak Inspiratory Pressure at 24 h.

  5 minutes, 24 hours

Secondary Outcomes (7)

• Airway Occlusion Pressure

  5 minutes, 12 hours, 24 hours

• Diaphragmatic excursion and Diaphragmatic thickening fraction

  5 minutes, 12 hours, 24 hours

• Peak coughing flow

  5 minutes, 12 hours, 24 hours

• Ph

  5 minutes, 12 hours, 24 hours

• PaCO2, PaO2

  5 minutes, 12 hours, 24 hours

Study Arms (1)

MagneticTape group

EXPERIMENTAL

The Magnetic Tape bandage will be placed by the patient's care team and will be placed in the anterior superior part of each hemithorax, matching the large vessels and lymph nodes, in the posterior part of the thorax in the paravertebral area from C3 to T9 and in the subcostal region, following the direct innervation of the thorax and shoulder girdle, as well as the dorsal levels with lateral horns that control the vascularisation of the thorax and shoulder girdle.

Other: Magnetictape bandage application

Interventions

Magnetictape bandage application OTHER

The Magnetic Tape bandage will be placed by the patient's care team and will be placed in the anterior superior part of each hemithorax, matching the large vessels and lymph nodes, in the posterior part of the thorax in the paravertebral area from C3 to T9 and in the subcostal region, following the direct innervation of the thorax and shoulder girdle, as well as the dorsal levels with lateral horns that control the vascularisation of the thorax and shoulder girdle.

MagneticTape group

Eligibility Criteria

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

You may qualify if:

• All patients who have received IMV for more than 48 hours and are intended to start the ventilator weaning process.

You may not qualify if:

• Adequate oxygenation (SatO2\>90% or PaO2\>60mmHg, FiO2\<0.4 and PEEP \<7).
• Patients under deep sedation+/- muscle relaxation
• Patients in need of OTI due to structural alterations of the central nervous system
• Patients with a history of previously known neurological disease
• Patients with wounds or burns in the paravertebral region, interscapular or subcostal region
• Patients with active oncological disease
• Patients with contraindication for exposure to electromagnetic fields
• Patients under 18 years of age.

Sponsors & Collaborators

• Hospital Universitario Doctor Peset: lead

Study Sites (1)

Hospital Universitario Doctor Peset

Valencia, 46002, Spain

RECRUITING

Related Publications (7)

• Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.

  PMID: 17470624 RESULT

• Esteban A, Alia I, Ibanez J, Benito S, Tobin MJ. Modes of mechanical ventilation and weaning. A national survey of Spanish hospitals. The Spanish Lung Failure Collaborative Group. Chest. 1994 Oct;106(4):1188-93. doi: 10.1378/chest.106.4.1188.

  PMID: 7924494 RESULT

• Esteban A, Ferguson ND, Meade MO, Frutos-Vivar F, Apezteguia C, Brochard L, Raymondos K, Nin N, Hurtado J, Tomicic V, Gonzalez M, Elizalde J, Nightingale P, Abroug F, Pelosi P, Arabi Y, Moreno R, Jibaja M, D'Empaire G, Sandi F, Matamis D, Montanez AM, Anzueto A; VENTILA Group. Evolution of mechanical ventilation in response to clinical research. Am J Respir Crit Care Med. 2008 Jan 15;177(2):170-7. doi: 10.1164/rccm.200706-893OC. Epub 2007 Oct 25.

  PMID: 17962636 RESULT

• Esteban A, Alia I, Tobin MJ, Gil A, Gordo F, Vallverdu I, Blanch L, Bonet A, Vazquez A, de Pablo R, Torres A, de La Cal MA, Macias S. Effect of spontaneous breathing trial duration on outcome of attempts to discontinue mechanical ventilation. Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med. 1999 Feb;159(2):512-8. doi: 10.1164/ajrccm.159.2.9803106.

  PMID: 9927366 RESULT

• Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481.

  PMID: 24108501 RESULT

• De Jonghe B, Sharshar T, Lefaucheur JP, Authier FJ, Durand-Zaleski I, Boussarsar M, Cerf C, Renaud E, Mesrati F, Carlet J, Raphael JC, Outin H, Bastuji-Garin S; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Paresis acquired in the intensive care unit: a prospective multicenter study. JAMA. 2002 Dec 11;288(22):2859-67. doi: 10.1001/jama.288.22.2859.

  PMID: 12472328 RESULT

• Ali NA, O'Brien JM Jr, Hoffmann SP, Phillips G, Garland A, Finley JC, Almoosa K, Hejal R, Wolf KM, Lemeshow S, Connors AF Jr, Marsh CB; Midwest Critical Care Consortium. Acquired weakness, handgrip strength, and mortality in critically ill patients. Am J Respir Crit Care Med. 2008 Aug 1;178(3):261-8. doi: 10.1164/rccm.200712-1829OC. Epub 2008 May 29.

  PMID: 18511703 RESULT

Study Officials

• Hector Hernández-Garcés, PhD

  University Hospital Dr. Peset

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hector Hernández-Garcés, PhD

CONTACT

+34963131652; hektorhernandez84@gmail.com

Samuel Fernández-Carnero, PhD

CONTACT

+34620895315; samuelfernandezcarnero@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Hector Hernández-Garcés

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: May 2, 2022
• Study Start: April 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)