Analysis of the Magnetic Tape Bandage on Respiratory Functional Effects.

Airway Extubation Clinical Trial

Official title:

Analysis of the Magnetic Tape Bandage on Respiratory Functional Effects in Patients After Extubation Failure a Quasi-experimental Randomized Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05356299
• Other study ID #: 123/20
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2022
• Source: Hospital Universitario Doctor Peset
• Contact: Hector Hernández-Garcés, PhD
• Phone: +34963131652
• Email: hektorhernandez84[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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 Intensive Care Units (ICU) stay and increase hospital costs. Similarly, premature withdrawal of ventilatory support may increase ICU patient mortality by requiring reintubation. The Mechanical Ventilation (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. In addition, 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, Inspiratory Maximum Pressure (IMP) and Airway Occlusion Pressure 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. Magnetic Tape® is an elastic adhesive bandage with a longitudinal elongation of 50-60% designed to facilitate the process of metameric normalisation by producing physical ionisation when it comes into contact with electromagnetic fields such as those produced in the skin thanks to the formulation of cations (+ ions) and anions (- ions) that it incorporates per square centimetre, acting both polarities (positive and negative) indistinctly and uninterruptedly at the same time, painless and non-invasive, stimulating the cutaneous receptors and nerves, allowing neural stimulation. The electromagnetic field acts as the vehicle to induce the flow of ions (physical ionisation) and does not stimulate the nerve tissue itself as electrical stimulation does directly. However, once the ion flow is created, the mechanism of electrical and magnetic stimulation at the neural level is the same, producing depolarisation of the axon and initiation of the action potential. The skin is the largest sensory organ in the body and is highly innervated. The nerve fibres it contains are the dendritic limbs of sensory neurons whose cell bodies are located in the dorsal root ganglia. The main effects studied so far are: 1) It provides a considerable, significant and immediate change in the improvement of joint Range of Movement (ROM); 2) It produces a decrease or elimination of perceived pain in all phases of therapeutic action such as prevention, treatment, recovery, readaptation or performance; 3) It helps to normalise the autonomic nervous system; 4) It normalises the body's dermal temperature; 5) It helps to reduce the collection of liquid after a contusion or fall; 6) It helps to produce myo-normalisation either by relaxation or stimulation; 7) It helps to improve the symptoms caused by scar adhesions. We consider it interesting, as a starting point in the field of medicine, to present this work and evaluate the effect of Magnetic Tape on the respiratory musculature and, therefore, on the parameters most commonly used for the evaluation of the same in ventilated patients who are going to undergo a Spontaneus Ventilation Test (SVT).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 31
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Airway Extubation

Intervention

Other:
• Magnetictape bandage application
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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Doctor Peset	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Doctor Peset

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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 — View Citation

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. — View Citation

De Jonghe B, Sharshar T, Lefaucheur JP, Authier FJ, Durand-Zaleski I, Boussarsar M, Cerf C, Renaud E, Mesrati F, Carlet J, Raphaël JC, Outin H, Bastuji-Garin S; Groupe de Réflexion et d'Etude des Neuromyopathies en Réanimation. Paresis acquired in the int — View Citation

Esteban A, Alía I, Ibañez 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. — View Citation

Esteban A, Alía I, Tobin MJ, Gil A, Gordo F, Vallverdú I, Blanch L, Bonet A, Vázquez A, de Pablo R, Torres A, de La Cal MA, Macías S. Effect of spontaneous breathing trial duration on outcome of attempts to discontinue mechanical ventilation. Spanish Lung — View Citation

Esteban A, Ferguson ND, Meade MO, Frutos-Vivar F, Apezteguia C, Brochard L, Raymondos K, Nin N, Hurtado J, Tomicic V, González M, Elizalde J, Nightingale P, Abroug F, Pelosi P, Arabi Y, Moreno R, Jibaja M, D'Empaire G, Sandi F, Matamis D, Montañez AM, Anz — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Airway Occlusion Pressure	The measurement will be performed using the software and the ventilator curves (Puritan Bennett 980 / 840, Medtronic, Dublin Ireland).	5 minutes, 12 hours, 24 hours
Secondary	Diaphragmatic excursion and Diaphragmatic thickening fraction	Assessment of diaphragmatic activity will be performed using ultrasound equipment.	5 minutes, 12 hours, 24 hours
Secondary	Peak coughing flow	The measurement will be performed using the ventilator software (Puritan Bennett 980 / 840, Medtronic, Dublin Ireland).	5 minutes, 12 hours, 24 hours
Secondary	Ph	Will be performed by analysis of arterial vs. venous blood sample.	5 minutes, 12 hours, 24 hours
Secondary	PaCO2, PaO2	Will be performed by analysis of arterial vs. venous blood sample.	5 minutes, 12 hours, 24 hours
Secondary	Time of mechanical ventilation	The number of days the patient has been under OTI since intubation shall be recorded.	5 minutes, 12 hours, 24 hours
Secondary	Weaning time	The number of days from the first PVE to extubation of the patient shall be recorded.	5 minutes, 12 hours, 24 hours