Clinical trial NCT05356299: Analysis of the Magnetic Tape Bandage on Respiratory Functional Effects.
Official title: Analysis of the Magnetic Tape Bandage on Respiratory Functional Effects in Patients After Extubation Failure a Quasi-experimental Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Airway Extubation
Keywords: Airway extubation failure
Magnetictape
Invasive mechanical ventilation
Lead sponsor: Hospital Universitario Doctor Peset
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Peak Inspiratory Pressure
timeFrame: 5 minutes, 24 hours
Secondary outcomes:
measure: Airway Occlusion Pressure
timeFrame: 5 minutes, 12 hours, 24 hours
measure: Diaphragmatic excursion and Diaphragmatic thickening fraction
timeFrame: 5 minutes, 12 hours, 24 hours
measure: Peak coughing flow
timeFrame: 5 minutes, 12 hours, 24 hours
measure: Ph
timeFrame: 5 minutes, 12 hours, 24 hours
measure: PaCO2, PaO2
timeFrame: 5 minutes, 12 hours, 24 hours
measure: Time of mechanical ventilation
timeFrame: 5 minutes, 12 hours, 24 hours
measure: Weaning time
timeFrame: 5 minutes, 12 hours, 24 hours
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
Study officials:
affiliation: University Hospital Dr. Peset
name: Hector Hernández-Garcés, PhD
role: PRINCIPAL_INVESTIGATOR
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