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.: PACTR202303563303199 Date of Approval: 31/03/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Video Laryngoscope Improves Nasotracheal Intubation in Maxillofacial Surgery: A Randomized Clinical Trial
Official scientific title Video Laryngoscope Improves Nasotracheal Intubation in Maxillofacial Surgery: A Randomized Clinical Trial
Brief summary describing the background and objectives of the trial The intubation can be done either through the orotracheal route or the nasotracheal route. Recently, a large number of technics are increasingly used for intubation such as the video laryngoscope. The video laryngoscope has been shown to improve the visualization of the upper airways and to allow better conditions in orotracheal intubation. We evaluate the effectiveness of the video laryngoscope compared to the macintosh laryngoscope in nasotracheal intubation for maxillofacial surgery. The study aimed to evaluate the effectiveness of the video laryngoscope compared to the Macintosh laryngoscope in patients undergoing oro-maxillofacial surgery requiring nasotracheal intubation.
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 Supportive care
Anticipated trial start date 01/01/2021
Actual trial start date 27/01/2021
Anticipated date of last follow up 01/12/2021
Actual Last follow-up date 12/12/2021
Anticipated target sample size (number of participants) 64
Actual target sample size (number of participants) 62
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 Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group M Group M: Patients to undergo nasotracheal intubation by a direct laryngoscope with a Macintosh laryngoscope. 11 months The included patients were randomly assigned into two groups using an online Random list generator (https://www.random.org/). We then obtained two groups based on the technique of intubation: - Group V: Patients to undergo nasotracheal intubation by video laryngoscopy Medcaptain®. - Group M: Patients to undergo nasotracheal intubation by a direct laryngoscope with a Macintosh laryngoscope. 31 Active-Treatment of Control Group
Experimental Group Group V Group V: Patients to undergo nasotracheal intubation by video laryngoscopy Medcaptain®. 11 months The included patients were randomly assigned into two groups using an online Random list generator (https://www.random.org/). We then obtained two groups based on the technique of intubation: - Group V: Patients to undergo nasotracheal intubation by video laryngoscopy Medcaptain®. - Group M: Patients to undergo nasotracheal intubation by a direct laryngoscope with a Macintosh laryngoscope. 31
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients aged between 20 and 65 scheduled for a maxillofacial surgery needing nasotracheal intubation, were included in this study if they had an ASA score (American society of anesthesiology) of I or II. Patients with a predicted difficult airway, hemostasis disorder, recurrent epistaxis, nasal deformation, recent nasopharyngeal surgery, obstructive sleep apnea, and BMI ≥ 35 kg/m2 were not included in this study. Patients who had narrow nostrils not allowing the passage of a tube adapted to the patient, patients with major epistaxis interfering with the visibility of the glottis, or patients with unexpected difficult intubation were excluded from this study. Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 65 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 27/01/2021 Comite de protection des personne du Sud
Ethics Committee Address
Street address City Postal code Country
ISIS. EL AIN ROAD KM 0.5. IN FRONT OF THE MEDICAL SCHOOL OF SFAX Sfax 3000 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The Passage of the intubation tube was done through 3 steps: First from the nose to the oropharynx, second from the oropharynx to the glottic entrance, and finally from the glottic entrance to the trachea. The primary outcome was the total intubation duration time The end of intubation
Secondary Outcome The Cormack and Lehane score At the end of intubation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Habib Bourguiba University Hospital El Ain Street Km 0.5 Sfax 3029 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Habib Bourguiba University Hospital El Ain Road Km 0.5 Sfax 3029 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Habib Bourguiba University Hospital El Ain Road Km0.5 Sfax 3029 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
Imen Zouche Department of anesthesiology. Habib Bourguiba University Hospital. EL Ain Road km 0.5 Sfax 3000 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Moncef Sellami sellami_moncef@yahoo.fr 0021624050980 Habib Bourguiba University Hospital. El AIn Road Km 0.5
City Postal code Country Position/Affiliation
Sfax 3029 Tunisia Department of otorhinolaryngology
Role Name Email Phone Street address
Public Enquiries Imen Zouche imen.zouche2016@gmail.com 0021658127457 Habib Bourguiba University Hospital. El AIn Road Km 0.5
City Postal code Country Position/Affiliation
Sfax 3029 Tunisia Department of anesthesiology
Role Name Email Phone Street address
Scientific Enquiries Salma Ktata slayma@hotmail.com 0021658512306 Habib Bourguiba University Hospital. El AIn Road Km 0.5
City Postal code Country Position/Affiliation
Sfax 3029 Tunisia Department of anesthesiology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Study protocol, Statistical Analysis Plan, Analytic Code will be available beginning 3 months and ending 5 years following article publication IPD Sharing Statement: the research team will share Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 5 years following article publication Proposal should be directed to sellami_moncef@medecinesfax.org To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 25/03/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 25/03/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information