- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06368973
Mechanical Ventilation-Associated Complications and Co-Morbidities in Children Admitted in Pediatric Intensive Care Unit
Mechanical Ventilation-Associated Complications and Co-Morbidities in Children Admitted in Pediatric Intensive Care Unit: A Retrospective Study
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Cairo, Egypt, 13511
- Benha University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Adverse events associated with mechanical ventilation
Time Frame: 4 weeks after following usage of invasive mechanical ventilation
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to assess incidence of complications associated with invasive ventilation in critically ill children
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4 weeks after following usage of invasive mechanical ventilation
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amany M. El-Rebigi, MD, Pediatric and Neonatology Department, Benha Faculty of Medicine, Benha University, Benha, Egypt
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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