Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201708002440345 Date of Approval: 18/07/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Diagnostic accuracy of lung ultrasonography combined with procalcitonin for the diagnosis of ventilator associated pneumonia
Official scientific title Diagnostic accuracy of lung ultrasonography combined with procalcitonin for the diagnosis of ventilator associated pneumonia
Brief summary describing the background and objectives of the trial Ventilator-associated pneumonia (VAP) is the most frequent nosocomial infection among critical patients and is associated with increased mortality, morbidity, and duration of mechanical ventilation (MV) and ICU stay, with an obvious impact on patient management costs.1-2 There is still no definitive, validated diagnostic gold standard procedure, and early diagnosis of VAP remains a challenge to the intensivist.3 At the bedside, diagnostic and monitoring imaging of pulmonary infections mainly relies on chest radiographs (CXRs), but this method is unreliable in daily practice in the critically ill.4-5 Lung ultrasound (LUS) is a simple, non irradiating, noninvasive, cost-effective, bedside technique. Many previous studies have found that LUS is an important means of distinguishing respiratory distress etiologies.6 It has also been successfully used to diagnose and monitor community acquired pneumonia.15-17 In the critically ill, a LUS score was reliable for quantifying lung aeration and monitoring antibiotic efficacy in VAP.7 Procalcitonin (PCT) expression in parenchymal tissue is induced by bacterial infection and its concentrations have been successfully used to diagnose and guide antibiotic therapy in lower respiratory tract infections.8,9 The aim of this study is to evaluate the diagnostic accuracy of the combination of LUS and PCT in the diagnosis of ventilator associated Pneumonia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied diagnosis of ventilator assosciated pneumonia,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/05/2017
Actual trial start date 01/06/2017
Anticipated date of last follow up 05/10/2017
Actual Last follow-up date 02/11/2017
Anticipated target sample size (number of participants) 93
Actual target sample size (number of participants) 90
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
3150/05/17 department of anesthesia and surgical ICU
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group (I): LUS only will be done for patients of this group. LUS only will be done for patients of this group. 24 hour A comprehensive scan was taken in six areas for each lung (superior and inferior areas in the anterior, lateral, and posterior fields using anterior and posterior axillary lines as landmarks). The following ultrasound findings were collected: (1) small subpleural consolidations (echo-poor regions > 0.5 cm in diameter, lobar/hemilobar consolidation defined by a tissue-like pattern, and dynamic li 30
Experimental Group Group (II): PCT only will be done for patients of this group. PCT only will be done for patients of this group. 24 hour PCT only will be done for patients of this group. 30
Experimental Group Group (III): LUS combined with PCT will be done for patients of this group. LUS combined with PCT will be done for patients of this group. 24 hour Technique of LUS: A comprehensive scan was taken in six areas for each lung (superior and inferior areas in the anterior, lateral, and posterior fields using anterior and posterior axillary lines as landmarks). The following ultrasound findings were collected: (1) small subpleural consolidations (echo-poor regions > 0.5 cm in diameter, lobar/hemilobar consolidation defined by a tissue-like patte 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients will be included in the study if their age ¿18, mechanical ventilation for more than 48 h, newly appeared/evolving CXR infiltrate, and two or more of the following clinical criteria: temperature ¿ 38.5 ¿C or hypothermia (< 36.5¿ ), leukocytosis > 104/mL, or leukopenia < 4.103/mL; purulent tracheal secretions; and PaO2/FIO2 < 300 mm Hg. Exclusion criteria comprised patients with ongoing pneumonia or if their age ¿ 18. 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/05/2017 research ethics committee
Ethics Committee Address
Street address City Postal code Country
1 elgeish street tanta 1122 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To evaluate to evaluate the diagnostic accuracy of the combination of LUS and PCT in the diagnosis of ventilator associated Pneumonia. Once the ventilator associated pneumonia is suspected lung ultrasound and procalcitonin level are done to ensure the diagnosis.
Secondary Outcome To assess the period of stay in the ICU After confirming the diagnosis of ventilator associated pneumonia, we will assess if early diagnosis well shorten the duration of stay in the ICU
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Anaesthesia Dept, Tanta Univ Hospital 1 el geish street tanta 11111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
anesthesia department 1 el geish street tanta 11111 Egypt
faculty of medicine 1 el geish street tanta 1122 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor anesthesia department 1 el geish street tanta 11111 Egypt Hospital
Secondary Sponsor faculty of medicine 1 el geish street tanta 1122 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Gehan Morsy Eid 7 tharwat street tanta 4444 Egypt
Mohamed Mohye Eldin AbuElyazed 15 el estad street tanta 5555 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator gehan eid gehan2552011@gmail.com 01287466651 7 tharwat street
City Postal code Country Position/Affiliation
tanta 4444 Egypt Lecturer of Anaesthesia and and Intesive care
Role Name Email Phone Street address
Public Enquiries gehan eid gehan2552011@gmail.com 01287466651 7 tharwat street
City Postal code Country Position/Affiliation
tanta 4444 Egypt Lecturer of Anaesthesia and and Intesive care
Role Name Email Phone Street address
Scientific Enquiries mohamed abu elyazed moh_yazed75@yahoo.com 01120014472 15 elestad street
City Postal code Country Position/Affiliation
tanta 5555 Egypt Lecturer of Anaesthesia and and Intesive care
REPORTING
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