Clinical trial NCT03431389: "Outcomes of Tracheostomy Done for Patients Admitted in Anesthesia Intensive Care Units of Assiut University Hospital"
Official title: "Outcomes of Tracheostomy Done for Patients Admitted in Anesthesia Intensive Care Units of Assiut University Hospital"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Tracheostomy Complication
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 81
Sex: ALL
Minimum age (years): 1
Maximum age (years): 79
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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:

1. proper timing of tracheostomy
2. process of decannulation.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Successful decanulation
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university main hospital, ICUs
state: Assiut Governorate
Study officials:
affiliation: Professor in anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt.
name: Hala S Abdelghaffar, MD
role: PRINCIPAL_INVESTIGATOR
References: