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.: PACTR201806003340429 Date of Approval: 21/04/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Perioperative efficacy of alveolar recruitment maneuvers versus thoracic epidural analgesia as a prophylaxis against lung atelectasis in obese patient
Official scientific title Effects of Thoracic Epidural Analgesia in Combination With alveolar Recruitment Maneuver on lung expansion and gas exchange after Upper Abdominal Surgery in Obese Patients
Brief summary describing the background and objectives of the trial The aim of the present study is to evaluate the effects of thoracic epidural analgesia in combination with alveolar recruitment maneuver on lung expansion and gas exchange after upper abdominal surgery in obese patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied lung atelectasis in obese patient,Nutritional, Metabolic, Endocrine,Respiratory,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 21/04/2018
Actual trial start date 21/04/2018
Anticipated date of last follow up 21/10/2018
Actual Last follow-up date 21/10/2018
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Not yet 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 Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group 1: Recruitment maneuver combined with continuous thoracic epidural analgesia. (RM-TEA group): throughout the operation Epidural analgesia started at the end of surgery during closure of the surgical incision. After endotracheal intubation ,sustained inflation of the lung obtained by increasing the inspiratory pressure to reach 40cm H2O , while lungs were recruited by increasing the PEEP in a stepwise fashion, first to 10 cm H2O (3breaths), then to 15cm H2O (3breaths), and finally to 20 cm H2O (10breaths) and sust 25
Experimental Group Group 2: Recruitment maneuver alone (RM group) throughout the operation the same done as in the first group without the use of TEA. Conventional analgesia in the form of intramuscular pethidine and intravenous paracetamol started at the end of surgery during closure of the surgical incisions. 25
Experimental Group Group 3: Thoracic Epidural analgesia (TEA) throughout the operation The same done as in the first group without the use of RM. The technique was performed with sterilized epidural set (B- BRAUN) including (Touphy needle, catheter, bacterial filter and low resistance syringe) 25
Control Group Group 4: control group: neither RM nor TEA throughout the operation control group: neither RM nor TEA will be used in this group: Analgesia was maintained with incremental doses of fentanyl (0.5mcg/kg) and conventional analgesia in the form of ( 1mg/kg) intramuscular pethidine and intravenous paracetamol done . 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria: male and female patients with body mass index averaged between (35-45) kg/m2 and age average between (18- 45) years, ASA 1 and 2 patients, prepared to undergo upper abdominal Exclusion criteria: pregnancy, cardiac diseases, history of ischemic heart disease and new York heart association (NYHA) class III or IV, per-existing pulmonary disease ,renal ,hepatic or neuro-muscular disease, smokers and any contraindications for regional anesthesia . 18 Year(s) 45 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 19/04/2018 aswan university
Ethics Committee Address
Street address City Postal code Country
el seel street aswan 35127 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ¿ Visual Analogue Scale (VAS) pain scores ¿ Respiratory rate (RR) ¿ Arterial oxygen saturation (SaO2or spo2), and arterial blood gas (ABG) including arterial partial pressure of oxygen (PaO2), arterial partial pressure of carbon dioxide (PaCo2) and O2 index ¿ Heart rate (HR) and Mean arterial blood pressure (MAP) were measured at regular intervals 30minutes post operative2hrs , 6hrs and 12 hrs postoperative
Secondary Outcome ¿ Any complications of the techniques ¿ Chest x ray done for identification of degree of lung expansion ¿ Length of ICU stay (days) ¿ Length of hospital stay (days) during the operation and after 2hrs in ICU postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine Aswan umiversity el seel street aswan 35127 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of medicine aswan university el seel street aswan 35127 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor sherif kamal arafa el bahr street tanta 35127 Egypt Funding Agency
Secondary Sponsor amir abozikary el sayed el seel street aswan 35127 Egypt Funding Agency
COLLABORATORS
Name Street address City Postal code Country
sherif kamal arafa el bahr street tanta 35127 Egypt
amir abozikary el sayed el seel street aswan 35127 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator sherif arafa sherifarafa1020@gmail.com 01005714014 el bahr street
City Postal code Country Position/Affiliation
tanta 35127 Egypt lecturer of anesthesia , icu .aswan university
Role Name Email Phone Street address
Public Enquiries sherif arafa sherifarafa1020@gmail.com 01005714014 el bahr street
City Postal code Country Position/Affiliation
tanta 35127 Egypt lecturer of anesthesia , icu .aswan university
Role Name Email Phone Street address
Scientific Enquiries sherif arafa sherifarafa1020@gmail.com 01005714014 el bahr street
City Postal code Country Position/Affiliation
tanta 35127 Egypt lecturer of anesthesia , icu .aswan university
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information