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

April 12, 2024 updated by: Amany Mohammed El-Rebigi, MD, Benha University

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

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.

Study Overview

Status

Completed

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.

Study Type

Observational

Enrollment (Actual)

315

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt, 13511
        • Benha University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events associated with mechanical ventilation
Time Frame: 4 weeks after following usage of invasive mechanical ventilation
to assess incidence of complications associated with invasive ventilation in critically ill children
4 weeks after following usage of invasive mechanical ventilation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Amany M. El-Rebigi, MD, Pediatric and Neonatology Department, Benha Faculty of Medicine, Benha University, Benha, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

April 11, 2024

First Submitted That Met QC Criteria

April 12, 2024

First Posted (Actual)

April 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • RC16-4-2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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