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.: PACTR202004476254378 Date of Approval: 24/04/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative study of the outcome of oral versus nasal intubation in neonates and infants undergoing cardiac surgery
Official scientific title Comparative study of the outcome of oral versus nasal intubation in neonates and infants undergoing cardiac surgery
Brief summary describing the background and objectives of the trial Children undergoing surgery for congenital heart disease require endotracheal intubation. Many factors may influence the choice between oral intubation and nasal intubation. The practice of oral versus nasal intubation seems to be institutionally based as practice varies widely based on perceived risks and benefits. Nasal intubation is thought to offer less like lihood of dislodgment intraoperatively during transesophageal echocardiography probe placement and manipulation, as well as more comfort postoperatively before extubation (Greene NH et al 2019). Nasal intubation, however, carries an increased risk of epistaxis associated with traumatic intubation, particularly after systemic heparinization. It is also technically slightly more difficult, and it may be associated with nasal skin breakdown and pressure ischemia during hypothermia and low-flow states. There is additional concern that nasotracheal intubation may be associated with increased risk of sinusitis secondary to obstruction of the normal drainage of the maxillary sinuses (Moore BM et al 2012, Holzapfel L et al 1993). Presence of particular pathogens in the nasal cavity also has been shown to be associated with surgical site infection in patients undergoing cardiac surgery (Muñoz P et al 2008). However, oral intubation may potentially be associated with oral aversion in neonates intubated for prolonged periods, as well as oral and lingual injury. Aim of the work and hypothesis The aim of this study is to compare the outcome of oral and nasal intubation in neonates and infants undergoing cardiopulmonary bypass (CPB). We will also explore potential associations between the route of intubation and the occurrence of infection, the risk of accidental extubation, oral/nasal injury, postoperative intubation length, and postoperative length of hospital stay. Our hypothesis is that nasal intubation in neonates and infants undergoing open heart surgery may be better tolerated than the oral intubation with subsequent reduction of the postoperative sedative analgesic requirements which will affect postoperative intubation length, and postoperative length of ICU and hospital stay
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 22/04/2020
Actual trial start date 01/05/2020
Anticipated date of last follow up 24/11/2021
Actual Last follow-up date 01/12/2021
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
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 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
Control Group oral intubation Group Patients will be intubated orally with suitable size non cuffed endotracheal tube. after induction of anesthesia atients will be intubated orally with suitable size non cuffed endotracheal tube. 100 Active-Treatment of Control Group
Experimental Group Nasal Group Patients will be intubated nasally with suitable size non cuffed endotracheal tube. after induction of anesthesia Patients will be intubated nasally with suitable size non cuffed endotracheal tube. 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
This study will be conducted on 200 patients of either sex with their age less than one year submitted for on pump cardiac surgery Patients will be excluded from the current study in case of refusal of their guardians, redo cardiac surgery, congenital deformity of the nose and palate, presence of contraindication to nasal intubation, coagulation disorders, renal, hepatic or pulmonary disease, heart failure and moderate to severe pulmonary hypertension. Child: 6 Year-12 Year,Infant: 0 Month-23 Month,Infant: 1 Month-23 Month,New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 1 Month(s) 12 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 07/03/2020 Mansoura Faculty of Medicine Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
2 El-Gomhouria Street Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Total dose of postoperative fentanyl consumption during the first postoperative 24 hours. first postoperative 24 hours.
Secondary Outcome 1- Maximum heart rate [HR] and invasive mean arterial blood pressure [MAP] during intubation. 2-Time that will be taken for intubation (seconds). We will define an intubation duration as starting when the bag and mask ventilation stopped before intubation and terminating when the positive pressure ventilation (PPV) started after inserting the ET tube. 3-Minimum oxygen saturation during intubation. 4- Number of nasal intubation trials and number of failed nasal intubation. 5- Accidental extubation either spontaneous or during trans esophageal echo probe manipulation. 6- Occurrence of traumatic complications of nasal intubation (epistaxis). 7- Time to extubation (hours). 8- Intensive care unit (ICU) and hospital length of stays. 9- Post-operative complications (the need for re-intubation, stridor, pneumonia, wound infection) 24 hours.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university children hospital 2 El-Gomhouria Street Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Ibrahim Abd Elbaser 2 El-Gomhouria Street Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university children hospital 2 El-Gomhouria Street Mansoura 35516 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ibrahim Ibrahim Abd Elbaser 2 El-Gomhouria Street Mansoura 35516 Egypt
Nabil Abd El raouf Abd El mageed 2 El-Gomhouria Street Mansoura 35516 Egypt
Mohamed Maher El Morsy 2 El-Gomhouria Street Mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ibrahim Abd Elbaser ibrahimbaser2010@yahoo.com +201004976825 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of Anesthesia and Surgical Intensive Care at Mansoura University
Role Name Email Phone Street address
Public Enquiries Nabil Abd Elraouf nabil_abdelraouf@yahoo.com +201001538648 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Professor of anesthesia and surgical Intensive care at faculty of medicine Mansoura university
Role Name Email Phone Street address
Scientific Enquiries Mohamed El Morsy dr.sevo.anesthesia@gmail.com +201112582480 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of Anesthesia and Surgical Intensive Care at Mansoura University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will individual participate data and share it through the PubMed indexed journal Informed Consent Form,Study Protocol Form,Study Protocol Beginning 6 months and ending 12 months following article publication We will individual participate data and share it through the PubMed indexed journal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://irb.mans.edu.eg 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