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.: PACTR202309750598928 Date of Approval: 22/09/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Video laryngoscope verses direct laryngoscope for endotracheal intubation among elective surgeries in Orotta and Halibet National Referral Hospitals Asmara, Eritrea.
Official scientific title Comparison of video laryngoscope and direct laryngoscope during endotracheal intubation: A Randomized Clinical Trial.
Brief summary describing the background and objectives of the trial Airway management plays an essential role in anesthesia during elective and emergency situations. Despite the necessity of extensive training and personal skills, direct laryngoscope stays the most widely used method of intubation. Video laryngoscope provides a better visualization of the airway, ease of use and short learning curve. However, with all its advantages, Video laryngoscope was less used as routine practice. The aim of the study was to compare C- MAC video laryngoscope and direct laryngoscope during endotracheal intubation. A randomized controlled trial was conducted on Patients undergoing elective surgery who were allocated randomly to each of the two Groups comprising of 48 patients in each as: Group I direct laryngoscope and Group II video laryngoscope.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Ear, Nose and Throat
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/01/2022
Actual trial start date 01/01/2022
Anticipated date of last follow up 10/02/2022
Actual Last follow-up date 10/02/2022
Anticipated target sample size (number of participants) 96
Actual target sample size (number of participants) 96
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 by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Video laryngoscope group Participants were intubated under general anesthesia using direct laryngoscope 5 min Patients initially were encountered during the preoperative assessment period. Informed written consent was obtained. A thorough Preanesthestic evaluation emphasis on the airway assessments was done. Previous anesthetic exposure and drug sensitivity were enquired.Routine preoperative laboratory investigations were conducted. No premedication was given. Patients were kept fasting for the night of 8 hours. In the preparation room, an intravenous 18G cannula was inserted with 1 liter of normal saline. Upon arrival to the operating room, patients were attached to vital sign monitoring instruments and continuous monitoring was carried out with noninvasive blood pressure and pulse oximetry and baseline vital signs were recorded before the start of the procedure.During the intraoperative period, patients were positioned on supine, pre oxygenated with oxygen for 2-3 min, after oxygen saturation reached 100%, general anaesthesia was induced with fentanyl, propofol/thiopental and after ventilating and good chest movement the patient was given Suxamethonium. After the patient is relaxed video laryngoscope (VL) was used to intubate the airway. Then the duration of intubation, numbers of attempt for intubation, Cormack lehane visuality, hemodynamic status (at the base line, after induction, 1min, and 5 min), ease of intubation, airway trauma, esophageal intubation and postoperative throat pain were recorded. 48
Control Group Direct Laryngoscope group Participants were intubated under general anesthesia using direct laryngoscope 5 min Patients initially were encountered during the preoperative assessment period. Informed written consent was obtained. A thorough Preanesthestic evaluation emphasis on the airway assessments was done. Previous anesthetic exposure and drug sensitivity were enquired. Routine preoperative laboratory investigations were conducted. No premedication was given. Patients were kept fasting for the night of 8 hours. In the preparation room, an intravenous 18G cannula was inserted with 1 liter of normal saline. Upon arrival to the operating room, patients were attached to vital sign monitoring instruments and continuous monitoring was carried out with noninvasive blood pressure and pulse oximetry and baseline vital signs were recorded before the start of the procedure. During the intraoperative period, patients were positioned on supine, pre oxygenated with oxygen for 2-3 min, after oxygen saturation reached 100%, general anaesthesia was induced with fentanyl, propofol/thiopental and after ventilating and good chest movement the patient was given Suxamethonium. After the patient is relaxed direct laryngoscope (DL) was used to intubate the airway. Then the duration of intubation, numbers of attempt for intubation, Cormack lehane visuality, hemodynamic status (at the base line, after induction, 1min, and 5 min), ease of intubation, airway trauma, esophageal intubation and postoperative throat pain were recorded. 48 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients from the age group >18 Elective patients under general anesthesia , patients ASA classification of I and II patients who have agreed to participate on the study patients who were intubated before arrival to operation theatre, those who were hemodynamic instability, upper respiratory tract infection and known history of difficult intubation. patients who declined to participate in the study. Adult: 19 Year-44 Year 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 21/01/2022 Research Ethical Clearance Committee
Ethics Committee Address
Street address City Postal code Country
wakiro street Asmara 0000 Eritrea
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome The secondary outcomes can be explained by the secondary effect of the provided interventions. Besides the primary outcome, they also have a secondary outcome on the patient conditions such as post- operative throat pain. The incidence of post-operative throat pain under direct laryngoscope (47.9%) was significantly greater (P=0.001) than video laryngoscope (14.6%). vital signs were recorded at base line , after induction of anesthsia then after one minute and five minutes. number of attempts and duration of intubation were recorderd in seconds.r
Primary Outcome The overall findings observed Video laryngoscope proven to have less time of intubation,and fewer esophageal intubations in comparison to direct laryngoscope. However, first attempt success rate, Cormack Lehane grade, drug type, ease of intubation, haemodynamic status were found to be statistically insignificant. Over all these finding demonstrate the efficacy and superiority of Video laryngoscope . vital signs were recorded at base line , after induction of anesthsia then after one minute and five minutes. number of attempts and duration of intubation were recorderd in seconds.r
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Orotta National Referral hospital Asmara Asmara 0000 Eritrea
Halibet National Referral Hospital Asmara Asmara 0000 Eritrea
FUNDING SOURCES
Name of source Street address City Postal code Country
Orotta College of Medcine and Health Sciences seharti street Asmara 0000 Eritrea
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Orotta College of Medicne and Health Sciences seharti Street Asmara 0000 Eritrea University
Secondary Sponsor Ministry of Health Research policy and HRD department Wekiro street Asmara 0000 Eritrea Governmental Sector
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Betiel Kidanemariam beteilyk@gmail.com 2917422105 Arediab Street
City Postal code Country Position/Affiliation
Asmara 0000 Eritrea Principal investigator and College lecture
Role Name Email Phone Street address
Public Enquiries Yonatan Andemeskel yonimer2@gmail.com 2917138237 121, Naval Base
City Postal code Country Position/Affiliation
Asmara 0000 Eritrea college lecturer and reserch coordinator
Role Name Email Phone Street address
Scientific Enquiries Micheal Mengistu Mikoberaki88@gmail.com 2917305987 Arbaete Asmara Street
City Postal code Country Position/Affiliation
Asmara 0000 Eritrea College lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all of the individual participants data collected during the trial after deidentification. Informed Consent Form Immediately following publication. no end date anyone who wishes to access the data, data will be available for any purpose and indefinitely
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 15/06/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 17/09/2023 Result - 17/09/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information