Clinical trial NCT05792501: Pulmonary Infections and Barotrauma Associated With MV IN PICU
Official title: Frequencies, Risk Factors and Outcome of Ventilation-Associated Lung Complications At Paediatric Intensive Care Unit (PICU)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventilator Associated Pneumonia (VAP)
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children aged one month to up to 16 years Intubated and connected to MV for at least 48hrs.

Brief summary: This study aims to determine the incidence, risk factors and outcome of ventilation associated common complication in the PICUs at Assiut University Children Hospital in Egypt.

Detailed description: A constellation of adverse effects and complications may be associated with mechanical ventilation,The following are the Commonest Complications of Mechanical Ventilation

1. Ventilator-associated pneumonia.
2. Ventilator-induced lung injury.
3. Ventilation induce Hemodynamic compromise leads to ARDS. Ventilator-Associated Pneumonia (VAP) It refers to nosocomial pneumonia occurring 48 hours or more after initiation of mechanical ventilation (MV)

It is the second most common HAI after blood stream infection in the paediatric age group, accounting for about 20% of all HAIs in the paediatric intensive care units (PICUs) and has a rate of 2.9- 21.6 per 1000 ventilator days.The risk factors responsible for VAP occurrence can be classified into:

A-Host related factors: include associated co-morbidities B-Device-related factors: include the endotracheal tube, the ventilation circuit, and the presence of a nasogastric or an orogastric tube.

C-Personnel related factors: include improper hand hygiene and inadequate use of personal protective equipment.

VAP is associated with increased hospital morbidity; mortality; duration of hospitalization by an average of 7-9 days per patient; and health care costs . The incidence rates of VAP are higher in developing countries with limited resources.

Ventilator-associated lung injury (VALI) It is the lung damage by application positive or negative pressure to the lung by mechanical ventilation.

The prevalence of VALI in children admitted to the paediatric intensive care unit (PICU) may approximate 10%.

Types of VALI:

* Voltrauma (This is damage caused by over-distension)
* Barotrauma (destructive entry of pressurised airway gases into the parenchyma, or into blood vessels.)
* Biotrauma (is known to upregulate pulmonary cytokine production)
* Oxygen toxicity (This is the damage caused by a high concentration of inspired oxygen)
* Recruitment /de-recruitment injury (atelectotrauma)
* Shearing injury Risk factors for VALI: blood product transfusion, acidaemia, and history of restrictive lung disease. larger tidal volume.

investigators observed lower mortality among children ventilated with Vt \~8 mL/kg actual bodyweight compared with \~10 mL/kg in a before-after retrospective study .

Ventilation induce Hemodynamic compromise leads to ARDS:

Definition: Decrease in mean arterial pressure of 60 mm Hg or an absolute decrease to a systolic blood pressure \< 80 mm Hg in the first 2 hours after intubation, required treatment for LTH with vasopressors.

primary factor influencing mortality in acute respiratory distress syndrome (ARDS) Incidence: 28.6% of patients intubated in the emergency department developed post-intubation hypotension, tatistically significant association between LTH and hyper carbic (PCO2 \> 50 mm) chronic obstructive pulmonary disease

Eligibility criteria: Inclusion Criteria:

* children aged one month to up to 16 years Intubated and connected to MV for at least 48hrs.

Exclusion Criteria:

* Neonates and cases connected to M.V less than 48 hours.

Primary outcomes:
measure: assess right sided heart failure post ventilator acquired pneumonia
timeFrame: one year from april 2022 to april 2023
Secondary outcomes:
measure: Asess the risk factors associated with barotrauma on mechanical ventilation
timeFrame: one year from april 2022 to april 2023
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: PICU
state: Assuit
Study officials:
References:
citation: Schouten LR, Veltkamp F, Bos AP, van Woensel JB, Serpa Neto A, Schultz MJ, Wosten-van Asperen RM. Incidence and Mortality of Acute Respiratory Distress Syndrome in Children: A Systematic Review and Meta-Analysis. Crit Care Med. 2016 Apr;44(4):819-29. doi: 10.1097/CCM.0000000000001388.
citation: Sud S, Sud M, Friedrich JO, Wunsch H, Meade MO, Ferguson ND, Adhikari NK. High-frequency ventilation versus conventional ventilation for treatment of acute lung injury and acute respiratory distress syndrome. Cochrane Database Syst Rev. 2013 Feb 28;(2):CD004085. doi: 10.1002/14651858.CD004085.pub3.