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

NCT ID: NCT03431389

Last Updated: 2018-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-01
• Study Completion Date: 2016-05-31

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.

Conditions

Tracheostomy Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Decannulated group

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.

Group Type: ACTIVE_COMPARATOR

Tracheostomy tube

Intervention Type: DEVICE

Tracheostomy done to all patients by open surgical technique and was done in ICUs without need to transfer to theatre.

Failure of decannulation group

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.

Group Type: ACTIVE_COMPARATOR

Tracheostomy tube

Intervention Type: DEVICE

Tracheostomy done to all patients by open surgical technique and was done in ICUs without need to transfer to theatre.

Interventions

Tracheostomy tube

Tracheostomy done to all patients by open surgical technique and was done in ICUs without need to transfer to theatre.

Intervention Type: DEVICE

Other Intervention Names

TT

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Hala Saad Abdel-Ghaffar

Professor of anesthesia and intensive care, faculty of medicine, Assiut university.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hala S Abdelghaffar, MD

Role: PRINCIPAL_INVESTIGATOR

Professor in anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt.

Locations

Assiut university main hospital, ICUs

Asyut, Assiut Governorate, Egypt

Countries

Egypt

Other Identifiers

IRB00008718/00045

Identifier Type: -

Identifier Source: org_study_id