NCT05792501

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

January 9, 2023

Last Update Submit

March 29, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • assess right sided heart failure post ventilator acquired pneumonia

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

    one year from april 2022 to april 2023

Secondary Outcomes (1)

  • Asess the risk factors associated with barotrauma on mechanical ventilation

    one year from april 2022 to april 2023

Interventions

type of therapy that helps you breathe or breathes for you when you can't breathe on your own

Eligibility Criteria

Age1 Month - 16 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children aged one month to up to 16 years Intubated and connected to MV for at least 48hrs.

You may qualify if:

  • children aged one month to up to 16 years Intubated and connected to MV for at least 48hrs.

You may not qualify if:

  • Neonates and cases connected to M.V less than 48 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PICU

Asyut, Assuit, 2063045, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 26509320BACKGROUND
  • 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.

    PMID: 23450549BACKGROUND

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsResuscitationEmergency TreatmentRespiratory Therapy

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

January 9, 2023

First Posted

March 31, 2023

Study Start

April 1, 2022

Primary Completion

April 30, 2023

Study Completion

June 30, 2023

Last Updated

March 31, 2023

Record last verified: 2023-03

Locations