Outcomes of Tracheostomy Done for Patients Admitted in Anesthesia Intensive Care Units of Assiut University Hospital

Study Overview
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Brief Summary
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This study was undertaken to Identify the factors affecting the outcomes of tracheostomy done in ICU for patients subjected to prolonged intubation and ventilation and to suggest guidelines to control: proper timing of tracheostomy process of decannulation.

Detailed Description
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Tracheostomy is described as the creation of a stoma at the skin surface which leads into the trachea. From the first tracheostomy until about 1930, the operation was performed exclusively for laryngeal obstruction. Nowadays, due to the development of the care of critically ill patients in intensive care units (ICUs), there are other indications for the procedure including prolonged intubation and pulmonary toilet. The initial management of patients in an intensive care unit involves a series of interventions that aim to stabilize and then optimize their physiological state. Mechanical ventilation (MV) is a commonly utilized intervention to support a patient's respiratory function. The second phase in ICU management focuses on weaning the patient from the artificial supportive mechanisms. The principle role of tracheostomy in the ICU is to expedite the weaning process in patients requiring prolonged mechanical ventilation and those predicted to be at risk of pulmonary aspiration. Tracheostomy facilitates weaning primarily by allowing increased level of patient activity and mobility. Tracheostomy protects the larynx and the upper airway from prolonged intubation which may lead to laryngotracheal stenosis. Patients with tracheostomies tend to have fewer days of mechanical ventilation because of the improvements in the respiratory physiology. This is especially in trauma patients. They have improved secretion clearance as suction is easy and less strength is required for expectoration. This may be linked to the lower incidence of pneumonia and respiratory infections seen, especially in trauma victims. Patients with tracheostomy are less sedated and therefore able to move in bed. The patients may also be able to swallow, so may be started on oral feeding sooner and mouth care is easier compared with an endotracheal tube (ETT) tube.

Official Title
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Outcomes of Tracheostomy Done for Patients Admitted in Anesthesia Intensive Care Units of Assiut University Hospital

Conditions
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Tracheostomy Complication

Intervention / Treatment
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* Device: Tracheostomy tube


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients who were admitted to the ICUs of the main Assiut University Hospital. mechanically ventilated and underwent tracheostomy during his/her stay in ICU. Exclusion Criteria: Patients who were admitted to ICUs and didn't need tracheostomy during the period of admission in ICU or after discharge from ICU, Patients who died during admission in ICUs before being tracheostomized, Patients who died during admission in ICUs after being tracheostomized and the cause of death was not related to the tracheostomy procedure or care.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Tracheostomy done to all patients by open surgical technique and was done in ICUs without need to transfer to theatre. The patients were followed up daily until discharge from ICU. The following items were recorded: Duration of application of tracheostomy tube before decannulation (cannulation time), complications of tracheostomy, mortality due to tracheostomy.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Decannulated group<br>Decannulation was considered when the patients were no longer in need for tracheostomy tube and fulfilled the criteria of decannulation: No need for mechanical ventilation, no chocking with oral intake, no chest infection, effective cough reflex, laryngeal examination show bilateral mobile vocal cords with sufficient gap. Trial of decannulation was considered successful, if there was no need to reapply tracheostomy within 6 months of decannulation. | Device: Tracheostomy tube<br>* Tracheostomy done to all patients by open surgical technique and was done in ICUs without need to transfer to theatre.<br>* Other names: TT;|
| Active Comparator: Failure of decannulation group<br>Decannulation was considered when the patients were no longer in need for tracheostomy tube and fulfilled the criteria of decannulation: No need for mechanical ventilation, no chocking with oral intake, no chest infection, effective cough reflex, laryngeal examination show bilateral mobile vocal cords with sufficient gap. Decannulation trail was considered failed if there was a need to reapplication of tracheostomy at the time of decannulation or within six months of decannulation the duration of follow up. | Device: Tracheostomy tube<br>* Tracheostomy done to all patients by open surgical technique and was done in ICUs without need to transfer to theatre.<br>* Other names: TT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful decanulation | Trial of decannulation was considered successful, if there was no need to reapply tracheostomy within 6 months of decannulation. | 6 month |