Mechanical Ventilation-Associated Complications and Co-Morbidities in Children Admitted in Pediatric Intensive Care Unit

Mechanical Ventilation Complication Clinical Trial

Official title:

Mechanical Ventilation-Associated Complications and Co-Morbidities in Children Admitted in Pediatric Intensive Care Unit: A Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06368973
• Other study ID #: RC16-4-2023
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2024
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: December 31, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mechanical Ventilation Complication

Locations

Country	Name	City	State
Egypt	Benha University Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events associated with mechanical ventilation	to assess incidence of complications associated with invasive ventilation in critically ill children	4 weeks after following usage of invasive mechanical ventilation