Ventilator Associated Pneumonia (VAP)NCT05792501
Pulmonary Infections and Barotrauma Associated With MV IN PICU
An observational study of Ventilator Associated Pneumonia (VAP), run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Ventilator Associated Pneumonia (VAP)
- What is being tested?
- Mechanical ventilation
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 16 years
- All sexes
- Child
Study population: children aged one month to up to 16 years Intubated and connected to MV for at least 48hrs.
Who may be able to join
- children aged one month to up to 16 years Intubated and connected to MV for at least 48hrs.
Who cannot join
- Neonates and cases connected to M.V less than 48 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Frequencies, Risk Factors and Outcome of Ventilation-Associated Lung Complications At Paediatric Intensive Care Unit (PICU)
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.
Read the detailed description
A constellation of adverse effects and complications may be associated with mechanical ventilation,The following are the Commonest Complications of Mechanical Ventilation
- Ventilator-associated pneumonia.
- Ventilator-induced lung injury.
- Ventilation induce Hemodynamic compromise leads to ARDS. Ventilator-Associated Pneumonia (VAP) It refers to nosocomial pneumonia occurring 48 hours or more after initiation of mechanical ventilation (MV)
It is the second most common HAI after blood stream infection in the paediatric age group, accounting for about 20% of all HAIs in the paediatric intensive care units (PICUs) and has a rate of 2.9- 21.6 per 1000 ventilator days.The risk factors responsible for VAP occurrence can be classified into:
A-Host related factors: include associated co-morbidities B-Device-related factors: include the endotracheal tube, the ventilation circuit, and the presence of a nasogastric or an orogastric tube.
C-Personnel related factors: include improper hand hygiene and inadequate use of personal protective equipment.
VAP is associated with increased hospital morbidity; mortality; duration of hospitalization by an average of 7-9 days per patient; and health care costs . The incidence rates of VAP are higher in developing countries with limited resources.
Ventilator-associated lung injury (VALI) It is the lung damage by application positive or negative pressure to the lung by mechanical ventilation.
The prevalence of VALI in children admitted to the paediatric intensive care unit (PICU) may approximate 10%.
Types of VALI:
- Voltrauma (This is damage caused by over-distension)
- Barotrauma (destructive entry of pressurised airway gases into the parenchyma, or into blood vessels.)
- Biotrauma (is known to upregulate pulmonary cytokine production)
- Oxygen toxicity (This is the damage caused by a high concentration of inspired oxygen)
- Recruitment /de-recruitment injury (atelectotrauma)
- Shearing injury Risk factors for VALI: blood product transfusion, acidaemia, and history of restrictive lung disease. larger tidal volume. investigators observed lower mortality among children ventilated with Vt ~8 mL/kg actual bodyweight compared with ~10 mL/kg in a before-after retrospective study .
Ventilation induce Hemodynamic compromise leads to ARDS:
Definition: Decrease in mean arterial pressure of 60 mm Hg or an absolute decrease to a systolic blood pressure < 80 mm Hg in the first 2 hours after intubation, required treatment for LTH with vasopressors.
primary factor influencing mortality in acute respiratory distress syndrome (ARDS) Incidence: 28.6% of patients intubated in the emergency department developed post-intubation hypotension, tatistically significant association between LTH and hyper carbic (PCO2 > 50 mm) chronic obstructive pulmonary disease
- Conditions
- Ventilator Associated Pneumonia (VAP)
- Being tested
- Mechanical ventilation
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ventilationDevice
type of therapy that helps you breathe or breathes for you when you can't breathe on your own
What is being measured
The primary outcome is the main question the study is designed to answer.
assess right sided heart failure post ventilator acquired pneumonia
use modified ross score for evaluation of heart failure post mechanical ventilation
Measured: one year from april 2022 to april 2023
Secondary outcomes (1)
Asess the risk factors associated with barotrauma on mechanical ventilation
previous chronic lung disease .previous NICU or PICU admission
Measured: one year from april 2022 to april 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start1 Apr 2022
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ventilator Associated Pneumonia (VAP)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Mahmoud Ezzat, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792501
- Sponsor's protocol ID
- Complication Of MV IN PICU
- Status last verified
- Mar 2023
- First submitted
- 9 Jan 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26509320Sud 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.
PubMed 23450549
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequencies, Risk Factors and Outcome of Ventilation-Associated Lung Complications At Paediatric Intensive Care Unit (PICU)
- ClinicalTrials.gov ID
- NCT05792501
- Acronym / sponsor ID
- Complication Of MV IN PICU
- Conditions
- Ventilator Associated Pneumonia (VAP)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A constellation of adverse effects and complications may be associated with mechanical ventilation,The following are the Commonest Complications of Mechanical Ventilation
- Ventilator-associated pneumonia.
- Ventilator-induced lung injury.
- Ventilation induce Hemodynamic compromise leads to ARDS. Ventilator-Associated Pneumonia (VAP) It refers to nosocomial pneumonia occurring 48 hours or more after initiation of mechanical ventilation (MV)
It is the second most common HAI after blood stream infection in the paediatric age group, accounting for about 20% of all HAIs in the paediatric intensive care units (PICUs) and has a rate of 2.9- 21.6 per 1000 ventilator days.The risk factors responsible for VAP occurrence can be classified into:
A-Host related factors: include associated co-morbidities B-Device-related factors: include the endotracheal tube, the ventilation circuit, and the presence of a nasogastric or an orogastric tube.
C-Personnel related factors: include improper hand hygiene and inadequate use of personal protective equipment.
VAP is associated with increased hospital morbidity; mortality; duration of hospitalization by an average of 7-9 days per patient; and health care costs . The incidence rates of VAP are higher in developing countries with limited resources.
Ventilator-associated lung injury (VALI) It is the lung damage by application positive or negative pressure to the lung by mechanical ventilation.
The prevalence of VALI in children admitted to the paediatric intensive care unit (PICU) may approximate 10%.
Types of VALI:
- Voltrauma (This is damage caused by over-distension)
- Barotrauma (destructive entry of pressurised airway gases into the parenchyma, or into blood vessels.)
- Biotrauma (is known to upregulate pulmonary cytokine production)
- Oxygen toxicity (This is the damage caused by a high concentration of inspired oxygen)
- Recruitment /de-recruitment injury (atelectotrauma)
- Shearing injury Risk factors for VALI: blood product transfusion, acidaemia, and history of restrictive lung disease. larger tidal volume. investigators observed lower mortality among children ventilated with Vt ~8 mL/kg actual bodyweight compared with ~10 mL/kg in a before-after retrospective study .
Ventilation induce Hemodynamic compromise leads to ARDS:
Definition: Decrease in mean arterial pressure of 60 mm Hg or an absolute decrease to a systolic blood pressure < 80 mm Hg in the first 2 hours after intubation, required treatment for LTH with vasopressors.
primary factor influencing mortality in acute respiratory distress syndrome (ARDS) Incidence: 28.6% of patients intubated in the emergency department developed post-intubation hypotension, tatistically significant association between LTH and hyper carbic (PCO2 > 50 mm) chronic obstructive pulmonary disease
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- children aged one month to up to 16 years Intubated and connected to MV for at least 48hrs.
Key inclusion criteria (1 listed)
- children aged one month to up to 16 years Intubated and connected to MV for at least 48hrs.
Key exclusion criteria (1 listed)
- Neonates and cases connected to M.V less than 48 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical ventilationtype of therapy that helps you breathe or breathes for you when you can't breathe on your own | Device | – |
Primary outcome
assess right sided heart failure post ventilator acquired pneumonia
Time frame: one year from april 2022 to april 2023
use modified ross score for evaluation of heart failure post mechanical ventilation
1 secondary outcome
Asess the risk factors associated with barotrauma on mechanical ventilation
Time frame: one year from april 2022 to april 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Background: PubMed 26509320Schouten 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.
- Background: PubMed 23450549Sud 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.
Related trials for Ventilator Associated Pneumonia (VAP)
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
Recruiting
Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia
Ventilator-Associated Pneumonia (VAP)
Recruiting
Effect of Ventilator Hyperinflation Combined With Body Positioning on ABG in VAP
Ventilator Associated Bacterial Pneumonia (VABP), Critical Illness
Active, not recruiting
HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array
HAP - Hospital Acquired Pneumonia, VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
Combined Use of a Respiratory Multiplex PCR and Algorithm-based Therapy to Improve Early Optimization of Antibiotic Therapy in Critically Ill Patients With Ventilator-associated Pneumonia
Ventilator Associated Pneumonia ( VAP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator Associated Pneumonia (VAP), run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess right sided heart failure post ventilator acquired pneumonia (time frame: one year from april 2022 to april 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05792501, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.