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.: PACTR201610001799417 Date of Approval: 01/10/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of the effect of lung recruitment and positive end- expiratory pressure (PEEP) on anesthesia induced atelectasis using lung ultrasound
Official scientific title Evaluation of the effect of lung recruitment and positive end- expiratory pressure (PEEP) on anesthesia induced atelectasis using lung ultrasound in children undergoing major abdominal surgery. A randomized Controlled Trial
Brief summary describing the background and objectives of the trial Atelectasis is a side effect of general anesthesia which can be found in all types of interventions and patients of all ages. The reported incidence of anesthesia- induced atelectasis in children varies, ranging from 12 to 42% in sedated and nonintubated patients and from 68 to 100% in children with general anesthesia with tracheal intubation or laryngeal mask.Such lung collapse causes arterial blood oxygenation to decline during and after anesthesia. Although anesthesia-induced atelectasis resolves spontaneously in children with American Society of Anesthesiology¿s (ASA) physical status classification I to II after minor surgical procedures, this entity may persist in the postoperative period in high-risk children undergoing complex surgeries. In the latter population, atelectasis potentially increases the risk for ventilator-induced lung injuryand could be associated with other postoperative pulmonary complications.Sonography is a simple, noninvasive, and radiation-free methodology which has gained increasing usage in daily practice. .Alveolar recruitment maneuver (ARM) is a technique using sustained airway pressure increase aiming at recruiting collapse alveoli, increasing lung area available for gases changes and consequently improving arterial oxygenation. It is not only used in ARDS patients but also in clinical situation with the development of collapsed lung areas (atelectasis).The aim of this work is to evaluate the effect of lung recruitment on anesthesia induced atelectasis using intraoperative lung ultrasound. Objectives ¿To determine the effect of recruitment on anesthesia induced atelectasis using lung ultrasound. ¿ To Estimate the change of Pao2 with anesthesia induced lung atelectasis. ¿To Estimate the change of Pao2 with lung recruitment. ¿To evaluate the feasibility of use of lung ultrasound as a tool to guide optimum lung recruitment.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied anesthesia induced atelectasis,Paediatrics,Respiratory,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/10/2016
Actual trial start date 01/10/2016
Anticipated date of last follow up 01/03/2017
Actual Last follow-up date 01/03/2017
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group lung recruitment group. continuous positive airway pressure( CPAP) (30) cm H2O (40) seconds , lung recruitment manoeuvre will be performed in patients using continuous positive airway pressure( CPAP) (30) cm H2O for (40) seconds after induction of anesthesia 20 Active-Treatment of Control Group
Control Group Without recruitment maneuver group patient ventilation will be maintained on pressure controlled mode targeting tidal volume 6-8 ml/kg with inspiratory to expiratory ( I: E) ratio 1:1.5, and Fio2 1without recruitment but with PEEP 5cm H2O. 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.ASA physical status I-II. 2.Age (1-4) years. 3.Patients undergoing major abdominal surgery in supine position (eg. Splenectomy, exploration, kasai etc.,). 1.Parents¿ refusal. 2.Patients with congenital heart disease. 3.Patients with chronic pulmonary disease ( asthma, bronchiectasis, emphysematous disease, etc.,) 4.Patients with respiratory tract infection. 5.Patients with chest wall deformities. 1 Year(s) 4 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 18/06/2016 Research Ethics Committee ,Faculty of medicine , Cairo university
Ethics Committee Address
Street address City Postal code Country
kasr alainy , faculty of medicine , cairo university cairo 202 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The lung aeration score 5minutes following induction of general anesthesia Atelectasis will be assessed by ultrasound using lung aeration score applied for each region. Lung score is four points (0 = normal lung, 1 = moderate aeration loss, 2 = severe aeration loss, 3 = complete aeration loss and consolidation) so, applying score for 12 regions bilateral will result in maximum score 36 and lowest score 0.
Secondary Outcome ¿Arterial oxygen tension (Pao2). Lung ultrasound examinations will be performed at different time-points immediately before induction of anesthesia, 5, 15 minutes following induction of general anesthesia, before extubation and after extubation at recovery room to detect and monitor atelectasis. Arterial blood samples will be collected simultaneously to measure Pao2
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Children Hospital of Cairo University 1 Abou EL Rish SQ.EL SAYEDA ZEINAB ,Cairo cairo 202 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
cairo university cairo university Rd, Giza GIZA 202 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Anesthesia department, Kasr alainy hospital kasr al ainy hospital , cairo university cairo 202 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mohamed Elayashy Mohamed El Haram , Giza Giza 202 Egypt
Riham Hussein Saleh kasr alainy cairo cairo 202 Egypt
Iman Riad M.Abdel- Aal kasr alainy, cairo cairo 202 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Nabih nabihomar100@yahoo.com 01002773488 7 Ahmed mukhtar hagazy st,manial,cairo
City Postal code Country Position/Affiliation
cairo 202 Egypt Assistant Lecturer of anesthesia, Faculty of medicine, Cairo University
Role Name Email Phone Street address
Public Enquiries Iman Riad imanriad2005@yahoo.com 01001226731 kasr alainy , cairo
City Postal code Country Position/Affiliation
cairo 202 Egypt Professor of anesthesia , pain management & surgical ICU. Faculty of medicine , Cairo university
Role Name Email Phone Street address
Scientific Enquiries Mohamed Elayashy mohamedelayashy@gmail.com 01001833155 EL Haram , Giza
City Postal code Country Position/Affiliation
Giza 202 Egypt Lecturer of anesthesia, pain management& surgical ICU
REPORTING
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