NCT04911244

Brief Summary

asses diagnostic performance of different methods for detection of ventilator associated pneumonia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Status
completed

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

August 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 2, 2021

Completed
Last Updated

June 2, 2021

Status Verified

May 1, 2021

Enrollment Period

3.2 years

First QC Date

May 24, 2021

Last Update Submit

May 30, 2021

Conditions

Ventilator Associated Pneumonia

Outcome Measures

Primary Outcomes (4)

  • To detected diagnostic accuracy of chest ultrasound in VAP.

    To identify sensitivity and specificity of chest ultrasound in VAP diagnosis

    3 years

  • To detected diagnostic accuracy of protected endotracheal aspirate in VAP.

    To identify sensitivity and specificity of protected endotracheal aspirate in VAP diagnosis

    3 years

  • To detected diagnostic accuracy of usual endotracheal aspirate in VAP.

    To identify sensitivity and specificity of usual endotracheal aspirate in VAP diagnosis

    3 years

  • To detected diagnostic accuracy of chest X-ray in VAP.

    To identify sensitivity and specificity of chest X-ray in VAP diagnosis

    3 years

Study Arms (2)

VAP group

EXPERIMENTAL

patients confirmed diagnosis of VAP with bronchoalveolar lavage

Diagnostic Test: bronchoalveolar lavage

Non VAP group

EXPERIMENTAL

patients confirmed not VAP with bronchoalveolar lavage

Diagnostic Test: bronchoalveolar lavage

Interventions

bronchoalveolar lavageDIAGNOSTIC_TEST

endobronchial sampling through bronchoscopy

Also known as: protected endotracheal aspirate
Non VAP groupVAP group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adult patients mechanically ventilated for at least 48 hours in Respiratory ICU were included in the study.
  • who had:
  • Clinically suspected VAP according to simplified Clinical Pulmonary Infectious Score exceeding 6.
  • Or new or extension of a radiological image with at least two of the following clinical criteria:
  • Body temperature ≥ 38.5 ° C or \<36 ° C.
  • Leukocytes\> 10 \* 103 / ml or \<4 \* 103/ ml or \> 10% immature cells (in the absence of other known causes).
  • Purulent tracheal secretions.
  • Hypoxemia with PaO2 \<60 mmHg or a PaO2 / FiO2 \<300.

You may not qualify if:

  • Patients with diagnosis of community acquired pneumonia or hospital acquired pneumonia before starting of mechanical ventilation.
  • Patients who are contraindicated for bronchoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Nair GB, Niederman MS. Ventilator-associated pneumonia: present understanding and ongoing debates. Intensive Care Med. 2015 Jan;41(1):34-48. doi: 10.1007/s00134-014-3564-5. Epub 2014 Nov 27.

    PMID: 25427866BACKGROUND

  • Bouhemad B, Liu ZH, Arbelot C, Zhang M, Ferarri F, Le-Guen M, Girard M, Lu Q, Rouby JJ. Ultrasound assessment of antibiotic-induced pulmonary reaeration in ventilator-associated pneumonia. Crit Care Med. 2010 Jan;38(1):84-92. doi: 10.1097/CCM.0b013e3181b08cdb.

    PMID: 19633538BACKGROUND

  • Mongodi S, Via G, Girard M, Rouquette I, Misset B, Braschi A, Mojoli F, Bouhemad B. Lung Ultrasound for Early Diagnosis of Ventilator-Associated Pneumonia. Chest. 2016 Apr;149(4):969-80. doi: 10.1016/j.chest.2015.12.012. Epub 2015 Dec 22.

    PMID: 26836896BACKGROUND

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

May 24, 2021

First Posted

June 2, 2021

Study Start

August 1, 2016

Primary Completion

October 1, 2019

Study Completion

February 1, 2020

Last Updated

June 2, 2021

Record last verified: 2021-05