Clinical trial NCT06368973: Mechanical Ventilation-Associated Complications and Co-Morbidities in Children Admitted in Pediatric Intensive Care Unit
Official title: Mechanical Ventilation-Associated Complications and Co-Morbidities in Children Admitted in Pediatric Intensive Care Unit: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Ventilation Complication
Keywords: Mechanical Ventilation, Complications,Co-morbidities.
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 315
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all pediatric patients aged 29 days to 16 years who were admitted to the PICU and underwent IMV for at least 24 hours between January 2021 and December 2023. Our analysis included data gathered from the follow-up medical records maintained by the PICU team and other healthcare providers.

Brief summary: The goal of this study was to identify the prevalence of mechanical ventilation-associated complications and co-morbidities in pediatric patients admitted to the PICU of Benha University Hospital, uncover how often these problems occur, their types, factors linked to them and to compare the epidemiology of MV-associated complications.

Detailed description: Mechanical ventilation (MV) is used frequently for critically ill children in pediatric intensive care unit (PICU). While respiratory disease is a major indication for invasive mechanical ventilation (IMV), there are also numerous non-respiratory indications for mechanical ventilation, including neurological and neuromuscular pathology, congenital heart disease, hemodynamic shock, and postoperative care and pain management and septic shock.

Although lung-protective ventilation strategies are extensively implemented in the pediatric population, frequent adverse events (AEs) of mechanical ventilation are detected, such as accidental extubation, atelectasis, trauma by aspiration, ventilator-associated pneumonia (VAP), perioral tissue damage, secretion-mediated obstruction of the endotracheal tube (ETT), mucus plugging, air leak syndromes, neuromyopathy, post-extubation stridor, and PICU delirium. Some of these events require the direct intervention of the physician, nurse, or physiotherapist in order to be identified; thus, they are associated with the quality of care.The incidence of these complications among pediatric patients in the PICU is noteworthy, with rates ranging from 27 to 97 adverse events per thousand patients per day. This is mainly associated with hazardous invasive procedures that can lead to unfortunate poor outcome.Few studies focus on the complications of using ventilators in infants and adolescents, especially regarding VAP cases.

The goal of this study was to identify the prevalence of mechanical ventilation-associated complications and co-morbidities in pediatric patients admitted to the PICU of Benha University Hospital, uncover how often these problems occur, their types, factors linked to them and to compare the epidemiology of MV-associated complications.

Eligibility criteria: Inclusion Criteria:

* all pediatric patients aged 29 days to 16 years who were admitted to the pediatric intensive care unit and underwent invasive mechanical ventilation for at least 24 hours between January 2021 and December 2023.

Exclusion Criteria:

* newborns (\<29 days old),
* pediatric patients received invasive mechanical ventilation less than 24 hours
* children with chronic respiratory failure or unable to be discharged due to socioeconomic constraints and requiring long-term mechanical ventilation therapy and pediatric patients with incomplete data or transferred to another hospital.

Primary outcomes:
measure: Adverse events associated with mechanical ventilation
timeFrame: 4 weeks after following usage of invasive mechanical ventilation
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Benha University Hospital
Study officials:
affiliation: Pediatric and Neonatology Department, Benha Faculty of Medicine, Benha University, Benha, Egypt
name: Amany M. El-Rebigi, MD
role: PRINCIPAL_INVESTIGATOR
References: