Pulmonary Infections and Barotrauma Associated With MV IN PICU

• Sponsor: Assiut University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05792501
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 14.9
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ventilator Associated Pneumonia (VAP)	Device: Mechanical ventilation

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

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Frequencies, Risk Factors and Outcome of Ventilation-Associated Lung Complications At Paediatric Intensive Care Unit (PICU)
• Actual Study Start Date: Apr 1, 2022
• Anticipated Primary Completion Date: Apr 30, 2023
• Anticipated Study Completion Date: Jun 30, 2023

Outcome Measures

Primary Outcome Measures

1. assess right sided heart failure post ventilator acquired pneumonia [one year from april 2022 to april 2023]

   use modified ross score for evaluation of heart failure post mechanical ventilation

Secondary Outcome Measures

1. Asess the risk factors associated with barotrauma on mechanical ventilation [one year from april 2022 to april 2023]

   previous chronic lung disease .previous NICU or PICU admission

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Month to 16 Years
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PICU	Assiut	Assuit	Egypt	2063045

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Abdelrahman Mahmoud Ezzat, principle investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT05792501
• Other Study ID Numbers: Complication Of MV IN PICU
• First Posted: Mar 31, 2023
• Last Update Posted: Mar 31, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pneumonia, Ventilator-Associated

Study Results

No Results Posted as of Mar 31, 2023