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.: PACTR202108492295773 Date of Approval: 26/08/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A Comparative Study between High Flow Nasal Oxygen Therapy and Venturi Mask Oxygen Therapy for Postoperative Laparoscopic Bariatric Surgery Patients with Atelectasis
Official scientific title A Comparative Study between High Flow Nasal Oxygen Therapy and Venturi Mask Oxygen Therapy for Postoperative Laparoscopic Bariatric Surgery Patients with Atelectasis: A randomized clinical trials
Brief summary describing the background and objectives of the trial The aim of this study is to compare the clinical outcome of treating postoperative laparoscopic bariatric surgery patients having atelectasis by using High Flow Nasal Oxygen Therapy versus Venturi Mask Oxygen Therapy. High flow nasal oxygen (HFNO2) therapy was first shown to be an effective treatment for acute respiratory failure in the pediatric and neonatal populations. Recently, it has gained popularity as a therapy in adult patients, with an expanding list of clinical applications.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/12/2019
Actual trial start date 01/12/2019
Anticipated date of last follow up 01/12/2020
Actual Last follow-up date 30/06/2021
Anticipated target sample size (number of participants) 110
Actual target sample size (number of participants) 110
Recruitment status Completed
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 randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group HFNO2 group stating with 30 L / min 6 hours stating with 30 L / min for 6 hours can be increased according to the patient needs then weaning takes place 55
Control Group VMO2 group venturi mask 60% 6 hours venturi mask 60% for 6 hours, can be increased according to patient clinical condition then weaning takes place 55 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients aged between 18 – 60 years old. Both genders. Preoperative Physical Status: ASA III Patients. BMI above 40 Kg/m2. Patients undergoing either laparoscopic sleeve gastrectomy or laparoscopic gastric mini-bypass with the presence of atelectasis confirmed clinically, radiologically and by arterial blood gases. Patients should be fully conscious upon ICU admission. Refusal of the intervention or participation in the study. Patient under age of 18 years old or above 60 years’ old. Pregnancy or lactation. Psychiatric illness. Known cases of chronic pulmonary disease. Known cases of cardiac diseases. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 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 20/08/2019 Ain Shams University Faculty of Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Abassia Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Partial pressure of oxygen PaO2/ fraction of inspired oxygen FiO2 and arterial Oxygen Saturation at 24 hours of Oxygen Therapy. postoperative period for 24 hours
Secondary Outcome Length of ICU stay. number of days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine Abbassya, Cairo , Egypt cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Asmaa Allam Shoubra Cairo 11231 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Abassia Cairo 11591 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Assistant Prof. Dr Mohamed Abdelsalam Aly Algendy Abassya Cairo 11591 Egypt
prof. Dr. Galal Adel Mohamed Abdelreheem Elkady Abassia Cairo 11591 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Asmaa Allam asmaanabeeh88@gmail.com 00201007428505 Shoubra
City Postal code Country Position/Affiliation
Cairo 11231 Egypt 1
Role Name Email Phone Street address
Scientific Enquiries Mohamed Algendy drgend2000@yahoo.com.au 00201001624439 Abassia
City Postal code Country Position/Affiliation
Cairo 11591 Egypt 1
Role Name Email Phone Street address
Public Enquiries Mohamed Sobhy Sobhy_m_7@hotmail.com 00201008440715 Abassia
City Postal code Country Position/Affiliation
Cairo 11591 Egypt 1
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data will be available Study Protocol Not applicable Not applicable
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 25/08/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 25/08/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information