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.: PACTR202008749509618 Date of Approval: 07/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title a novel airway device for for diagnostic trans esophageal echocardiography in pediatrics
Official scientific title Efficacy of the laryngeal mask airway gastro during trans esophageal echocardiography in pediatrics: A randomized trial.
Brief summary describing the background and objectives of the trial The laryngeal mask airway (LMA) Gastro is a new LMA with an endoscopy channel The LMA Gastro facilitated esophageal intubation while providing a positive pressure lung ventilation with clinically satisfactory seal pressures.The aim of our study is to evaluate the success of insertion of LMA Gastro for diagnostic TEE in pediatric patients and related airway and ventilation adverse effects
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Cardiology,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 15/08/2020
Actual trial start date
Anticipated date of last follow up 15/02/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 140
Actual target sample size (number of participants)
Recruitment status Active, not 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group endotracheal tube endotracheal tube will be inserted from the start of the procedure to the end the whole duration of the procedure endotracheal tube of appropriate size will be inserted after induction of anesthesia then will be removed at the end of the procedure 70 Placebo
Experimental Group LMA Gastro Laryngeal mask airway Gastro will be inserted from the start of the procedure to the end the whole duration of the procedure Laryngeal mask airway Gastro will be inserted after the induction of anesthesia and it will be removed at the end of the procedure 70
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
One hundred and forty patients eligible for elective interventional TEE in the cardiac lab. aged 8-18 years old, ASA II and III weighed ≥ 30 kg predicted difficult airway, known cervical spine disease, neurodevelopmental delay, patients with risk of aspiration or any contraindication to supraglottic airway device insertion, those requiring TEE for complex intervention (e.g. heart surgery, interventional procedures >60 min), hemodynamically unstable patients, those who need ventilatory support. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 8 Year(s) 18 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 16/07/2020 research ethics committee
Ethics Committee Address
Street address City Postal code Country
elgeish St. Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome measure the success rate of the TEE insertion at the start of the procedure
Secondary Outcome Success rate of TEE insertion at first time at the start of the procedure
Secondary Outcome Recovery time from extubation to discharge from the recovery room
Secondary Outcome cardiologist's satisfaction at the end of the procedure
Secondary Outcome adverse effects during the procedure and up to discharge from the recovery room
Secondary Outcome success rate of LMA Gastro insertion at the start of the procedure
Secondary Outcome success rate of LMA Gastro insertion at first attempt at the start of the procedure
Secondary Outcome ease of insertion after placement of airway device
Secondary Outcome extubation time time interval from discontinuation of anesthesia to removal of the airway
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Faculty of Medicine El-Geish st Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Mona Raafat Elghamry Elgeish st Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Mona Raafat Elghamry Elgeish st Tanta 31527 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Mona Raafat Elghamry Elgeish st Tanta 31527 Egypt
Atteia Gad Anwar Elgeish st Tanta 31527 Egypt
Amr Arafa Mohammed Elbadry Elgeish st Tanta 31527 Egypt
Aliaa Shaaban Elgeish st Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Atteia Anwar atteiagad@gmail.com +201025547544 Elgeish st
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant professor
Role Name Email Phone Street address
Public Enquiries Mona Elghamry drmonagh19802000@gmail.com +201060101867 Elgeish st
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Amr Elbadry amrarafa009@gmail.com +201285155509 Elgeish st
City Postal code Country Position/Affiliation
Tanat 31527 Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes statistics of success rate of TEE & LMA Gastro insertion,cardiologist's satisfaction,ease of airway device insertion, extubation time ,recovery time , and adverse effects Statistical Analysis Plan IPD will be shared after finishing and publication of the study.and it will be available for 6 months the IPD will be available for scientific researcher up on e-mail request with reason of the request. request will be sent to e-mail of drmonagh19802000@gmail.com
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