Patient Application
CADENCE™

When considering an adult patient with a Tracheostomy as a candidate for the
Cadence Self-Breathing System, the indications, contraindications and
precautions should be carefully and thoroughly reviewed. It should be
determined if the patient is medically ready for the initiation of self-breathing
trials. The table presents criteria and descriptions that can be considered in
estimating patient preparedness for Cadence Self-Breathing Trials.
Criteria that can be Considered in Estimating Patient Preparedness for Self-
Breathing Trials*

Estimating Patient Preparedness for Cadence Self-Breathing Trials
Criteria Description
Objective Measurements Adequate oxygenation (e.g., PO2 > 60 mm Hg on FiO2 < 0.4; PEEP < 5-10 cm H2O; PO2/ FiO2> 150-300)
 Stable cardiovascular system (e.g., HR < 140; stable BP; no (or minimal) pressures)
 Afebrile (temperature < 38°C)
 No significant respiratory acidosis
 Adequate hemoglobin (e.g., Hgb > 8-10 g/dL)
 Adequate mentation (e.g., arousable, GCS > 13, no continuous sedative infusions)
 Stable metabolic status (e.g., acceptable electrolytes)
Subjective Clinical Assessments Resolution of disease acute phase; physician believes discontinuation possible; adequate cough
*Hgb=hemoglobin; HR=heart rate; GCS= Glasgow coma scale

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The ability of the patient to breathe through the upper airway must first be
evaluated prior to Cadence Self-Breathing Therapy initiation. It is
recommended that the "Deflated Cuff Tracheostomy Occlusion Procedure" be
performed to evaluate airflow through the upper airway.

Patient Selection
Checklist
Consider the following checklist during patient selection. All criteria in the
checklist must be met in order to be considered for the Cadence Self-
Breathing Trial.

 

Patient Selection Checklist
Criteria Met Patient Criteria

The patient is an adult.

The patient is greater than or equal to 160 cm (63 inches) tall.

The patient has a body mass greater than or equal to 30 kg (66 pounds).

The patient is free of surgical complications, fever, infection, inflammation and hemodynamic instability.

The patient is able to move air readily in and out past the tracheostomy tube with the cuff deflated and the stoma occluded.

The patient has a Portex Blue Line Fenestrated tracheostomy tube size # 7, # 8 or #9) .

The patient can easily communicate with the care team.

The patient has NOT had a recent tracheotomy or tracheotomy revision with post procedure inflammation, edema, and/or bleeding.

The patient does NOT have airway abnormalities that impair proper functioning of the tracheostomy tube.

The patient does NOT have a tracheostomy tube oversized for patient's trachea.

The patient does NOT need an inflated tracheostomy tube cuff.

The patient does NOT use a foam filled cuffed tracheostomy tube.

The patient does NOT have significantly impaired swallow or significant aspiration of gastric content.

The patient does NOT have copious uncontrolled upper airway secretions.

The patient does NOT have significant problems with mucus plugging.

The patient does NOT have a lack of medical readiness for self-breathing trial.

The patient does NOT have high PEEP.

High FiO2requirements.

The patient does NOT have severely impaired ventilatory drive.

The patient does NOT have respiratory muscle fatigue or paralysis.

The patient does NOT have unresolved disease acute phase process (infection, sepsis, bleeding).

The patient does NOT have unstable post surgical condition.

The patient does NOT have hemodynamic instability.

The patient does NOT have fever.

The patient does have significant respiratory acidosis.

The patient does NOT have unstable metabolic status.

The patient does NOT have Anemia.

The patient does NOT have absence of cough reflex.

The patient is NOT unconsciousness or experience delirium.

The patient does NOT have severe agitation and/or significant sedation requirements.

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Esprit

 

Guidelines To Establish Patient Evaluation & Selection, System Preparation & Clinical Application

Download the Guidelines Document

Patient Monitoring

Catheter Tip Verification

It is recommended that an AP portable chest radiograph with the
appropriate Portex Blue Line Fenestrated Cuffed Tracheostomy Tube in place is
obtained to estimate catheter size for initial use. The radiograph should be
reviewed to measure the distance from the tip of the tracheostomy tube to the
carina. The optimal placement of the tip of the Cadence Catheter is 2 to 3 cm
above the carina.
As a clinical example, if the chest radiograph obtained with the #8 Portex Blue
Line Fenestrated Cuffed Tracheostomy Tube in place shows a distance of 6 cm
between the tracheostomy tube and the carina. 13.5 cm catheter extends 3
cm beyond the end of the tracheostomy tube placing the catheter within the
recommended distance of approximately 2-3 cm above the carina.

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Oxygen Saturation and Heart Rate

The time-criticality of oxygen transport requires frequent to continual
monitoring of oxygen saturation. Pulse oximetry provides the necessary arterial
oxygen saturation monitoring and offers heart rate monitoring, as well. The
pulse oximeter should be configured such that abnormal oxygen saturation and
heart rate alarms are always audible to a clinician responsible for the Cadence
Self-Breathing Trial patient.

Airway Pressure Monitoring

Use of the Criterion 40 Airway Pressure monitoring device with adjustable high
pressure alarm is recommended. The tubing of the monitoring system is
attached to the Cadence Catheter connector. The monitoring system measures
pressure within the tracheal tube lumen. High airway monitor pressures reflect
tracheal airway pressures except under conditions causing occlusion or
obstruction of the device monitoring tubing or the lumen of the tracheostomy
tube above the fenestrations and surrounding the catheter.

Delivered FiO2

An oxygen analyzer should be used periodically to monitor and adjust delivered
FiO2. The FiO2 should be titrated to the lowest setting using pulse oximetry or
ABG's that achieve adequate oxygenation to reduce the risk of oxygen toxicity.

Arterial Blood Gas

Arterial blood gas (ABG) analysis is common practice and can be of significant
clinical value when direct measurement of ventilation, blood oxygen and acidbase
status are necessary. ABG analysis should be considered at the end of the
first Cadence Self-Breathing Trial. In addition, ABG analysis should be
obtained whenever clinically appropriate.

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Clinical Assessment

Bedside observational assessment by a trained clinician is critically important.
The qualified clinician should be present at the bedside as medically
appropriate. Objective measurement of vital signs can be helpful. Patients
should be encouraged to talk so that symptoms can be identified, and
appropriate education and reassurance can be given when the patient has
questions or concerns. Gross inspection and examination of the chest are
important features of the bedside assessment. Abnormalities suggesting
respiratory compromise should be identified by clinicians.

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