NCT03266380

Brief Summary

The primary objective of this study is to assess the incidence of VAP in patients with TBI and to identify risk factors for developing VAP in this specific patient population (types of co-injuries in patients with multiple trauma or characteristics on admission). The secondary objective is to assess the prevalence of pathogens responsible for early- and late-onset VAP in patients with TBI. The tertiary objective is to discuss the ability of preventive measures to reduce the incidence of VAP

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

September 8, 2017

Status Verified

September 1, 2017

Enrollment Period

1.9 years

First QC Date

August 28, 2017

Last Update Submit

September 6, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Risk factors and common preventive measures for ventilator associated pneumonia in patients with severe traumatic brain injury Risk factors and common preventive measures for ventilator associated pneumonia in patients with severe traumatic brain injury

    The patients are divided into three groups, as follows: patients who donot develop VAP, those who develop early onset VAP, and those who develop late-onset VAP • The primary objective of this study is to assess the incidence of VAP in patients with TBI and to identify risk factors for developing VAP in this specific patient population (types of co-injuries in patients with multiple trauma or characteristics on admission). The secondary objective is to assess the prevalence of pathogens responsible for early- and late-onset VAP in patients with TBI. The tertiary objective is to discuss the ability of preventive measures to reduce the incidence of VAP.

    all patients admitted to general or trauma ICU in assiut university hospital will be recorded from january 2018 to december 2018

Interventions

observationalDIAGNOSTIC_TEST

All patients do an emergency brain computed tomography scan. Intracranial hypertension is treated with mannitol with or without a craniotomy. A third generation cephalosporin (ceftriaxone) and metronidazole are administered as antibiotic prophylaxis for accompanying wound injuries (skin and soft tissue). VAP preventive strategies that are performed in the ICU include daily interruption of sedation and a readiness to extubate assessment, early facilitation of mobility, elevating the head of the bed to 30- 45 degree, change of the ventilator circuit if visibly soiled or malfunctioning, stress ulcer prophylaxis, residual gastric volume monitoring, early parenteral nutrition, and deep venous thrombosis prophylaxis. An infusion of midazolam and propofol is to be used for sedation.

Eligibility Criteria

Age10 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The patients are divided into three groups, as follows: patients who donot develop VAP, those who develop early onset VAP, and those who develop late-onset VAP with no age or sex predliction

You may qualify if:

  • \- All patients with TBI who are on MV for \>48 h after the initial evaluation.
  • Patients are transferred either from the emergency room directly to the ICU, or they are transferred to the operating room first and are then admitted to the ICU after surgery.
  • Patients intubated outside the hospital and who had no side effects are also included.

You may not qualify if:

  • \- Patients with documented gastric aspiration, recent antibiotic therapy, 2 days of hospitalization in the preceding 30 days, residence in a nursing home or extended care facility, home therapy, or an underlying malignancy are excluded.
  • Patients who are transferred within the hospital if there was an accident or change in the ventilator system, or who have other known risk factors for developing pneumonia, are also excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist at anesthesia and ICU department

Study Record Dates

First Submitted

August 28, 2017

First Posted

August 30, 2017

Study Start

January 1, 2018

Primary Completion

December 1, 2019

Study Completion

December 30, 2019

Last Updated

September 8, 2017

Record last verified: 2017-09