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.: PACTR202205629173217 Date of Approval: 31/05/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Assessment of the routine application of double modified nasopharyngeal airways versus the use of low-flow nasal cannula during pediatric upper gastrointestinal endoscopy.
Official scientific title Application of double modified nasopharyngeal airways during pediatric upper gastrointestinal endoscopy.
Brief summary describing the background and objectives of the trial Upper gastrointestinal (GI) endoscopy is an important diagnostic and therapeutic procedure that is commonly conducted in children under general anesthesia or deep sedation. The purpose of this study is to evaluate the effectiveness of inserting bilateral NPA during pediatric endoscopic sedation for upper GI endoscopy compared to the standard use of LFNC. We hypothesize that bilateral NFA is non-inferior to LFNC in terms of the incidence of hypoxic events and respiratory instability.
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 Prevention
Anticipated trial start date 01/06/2022
Actual trial start date 01/06/2022
Anticipated date of last follow up 01/11/2022
Actual Last follow-up date 01/12/2022
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
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 Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group A Throughout the endoscopic procedure In group A (intervention group), the correct sizes of double-well lubricated (using lidocaine gel) NPAs will be bilaterally inserted via nostrils once the patients have attained the deep level of sedation (i.e., stoppage of active body movements). The correct size of the NPA will be identified by measuring from the tip of the patient’s nose to the tip of the earlobe. The maximum diameter of the airway that will fit will be used. To ensure this, we will select a size that is close to the diameter of the patient's little finger. The NPAs will be advanced carefully, with the bevel directed toward the nasal septum, along the floor of the nasopharynx until the flanges rest against the nostrils. The correct placement of the NPA should be distal to the soft palate and proximal to the epiglottis. The NPAs will then be attached to endotracheal tube connectors of the same size, which will be subsequently coupled to a double-lumen endotracheal tube connector, enabling simple connection to the anesthesia circuit. Spontaneous ventilation will be allowed, with periods of intermittent manual assisted ventilation provided as needed. 25
Control Group Group B Throughout the endoscopy procedure. In group B (control group), the patients will receive low-flow supplemental oxygen (3 L/min) via a nasal cannula. 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The study will enroll children of both sexes aged between 1 and 10 years old with an ASA physical status of I-II who will undergoing elective upper GI endoscopy under deep sedation. Children will be excluded from the study if they have significant cardiovascular, hepatic, renal, or respiratory disorders. Patients with upper airway anatomical disorders, malignancy, known allergies to the drugs used, or who will require emergency procedures will be also excluded from the study. Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 1 Year(s) 10 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 06/07/2022 Ain Shams University Faculty of Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ramsis street, Abassia Cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The frequency of hypoxic events (SaO2 <90% for more than 15 seconds as identified by pulse oximetry or apnea for more than 15 seconds as identified by respiratory monitoring). Throughout the endoscopic procedure
Secondary Outcome Duration of endoscopy, gastroenterologist's satisfaction, incidence of nasopharyngeal injury caused by NPA insertion, bradycardia (heart rate <60 beats/min), hypotension (systolic blood pressure <20% from baseline), indication of endoscopy, and the occurrence of other side effects (e.g., nausea and vomiting). Throughout the endoscopic procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University educational pediatric hospital Ramsis street, Abbassia Cairo 11566 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ain Shams university Ramsis street, Abassia Cairo 11566 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mostafa Mansour Hussein Ramsis street, Abassia Cairo 11566 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mostafa Mansour Hussein Ramsis street Cairo 11566 Egypt
Akram Mohamed Amer Ramsis street Cairo 11566 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mostafa Mansour Hussein mostafa.mansor@med.asu.edu.eg 00201093322145 Ramsis street
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Assistant professor of anesthesia and intensive care faculty of medicine Ain Shams university
Role Name Email Phone Street address
Public Enquiries Mostafa Mansour Hussein mostafa.mansor@med.asu.edu.eg 00201093322145 Ramsis street, Abassia
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Assistant professor of anesthesia and intensive care faculty of medicine Ain Shams university
Role Name Email Phone Street address
Scientific Enquiries Mostafa Mansour Hussein mostafa.mansor@med.asu.edu.eg 00201093322145 Ramsis street, Abassia
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Assistant professor of anesthesia and intensive care faculty of medicine Ain Shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification. (including text, tables, figures, and appendices) Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication. No end date. Anyone who wishes to access the data. For any type of analyses. The data will be available in our university’s data warehouse.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information