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CTRI Number  CTRI/2023/08/056258 [Registered on: 08/08/2023] Trial Registered Prospectively
Last Modified On: 06/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Other (Specify) [Procedure ]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the time to successful intubation in Video Laryngoscopy and Direct Laryngoscopy in Paediatric patients undergoing planned surgery under General Anaesthesia. 
Scientific Title of Study   A Comparative Study of Video Laryngoscopy and Direct Laryngoscopy for Elective Tracheal Intubation in Paediatric Patients. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Peter Marandi 
Designation  Junior Resident 
Affiliation  Rajendra Institute of Medical Sciences,Ranchi 
Address  Department of Anaesthesiology, Rajendra Institute of Medical Sciences, Ranchi, Bariatu, Ranchi - 834009, Jharkhand

Ranchi
JHARKHAND
834009
India 
Phone  7762925242  
Fax    
Email  petermarandi08@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dipali Singh 
Designation  Additional Professor  
Affiliation  Rajendra Institute of Medical Sciences,Ranchi 
Address  Department of Anaesthesiology, Rajendra Institute of Medical Sciences, Ranchi, Bariatu, Ranchi - 834009, Jharkhand

Ranchi
JHARKHAND
834009
India 
Phone  9620310511  
Fax    
Email  dipalishio@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bharati 
Designation  Assisstant Professor 
Affiliation  Rajendra Institute of Medical Sciences,Ranchi 
Address  Department of Anaesthesiology, Rajendra Institute of Medical Sciences, Ranchi, Bariatu, Ranchi - 834009, Jharkhand

Ranchi
JHARKHAND
834009
India 
Phone  9599277395  
Fax    
Email  bharati.bediya@gmail.com  
 
Source of Monetary or Material Support  
Rajendra Institue Of Medical Sciences, Ranchi, Bariatu, Ranchi Jharkhand 834009 
 
Primary Sponsor  
Name  Rajendra Institute of Medical Sciences Ranchi 
Address  Bariatu, Ranchi, Jharkhand 834009 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Peter Marandi  Rajendra Institute of Medical Sciences, Ranchi  Pediatric Surgery OT 5th Floor, Cardiology Building Rajendra Institute of Medical Sciences, Ranchi Bariatu, Ranchi, Jharkhand, 834009
Ranchi
JHARKHAND 		 7762925242

petermarandi08@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, RAJENDRA INSTITUTE OF MEDICAL SCIENCES, RANCHI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Direct Laryngoscopy  Time taken to Intubate starting from introduction of the laryngoscope blade between the two lips till the first capnographic confirmation following intubation. 
Intervention  Video Laryngoscopy  Time taken to Intubate starting from introduction of the laryngoscope blade between the two lips till the first capnographic confirmation following intubation. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  ASA status type I or II.

Elective Surgery requiring General Anaesthesia with tracheal intubation.

Informed consent by the Patient’s legal representatives. 
 
ExclusionCriteria 
Details  Patient/Parent/Legal Guardian unwilling.

Case of Head Injury.

Case of Emergency cases.

Case of Aspiration of Foreign Body.

Other comorbidities. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the time to successful intubation in Video Laryngoscopy & Direct Laryngoscopy in Paediatric patients undergoing Elective Airway Management.  At the time of intubation. 
 
Secondary Outcome  
Outcome  TimePoints 
a. To find out the frequency of attempts to intubate.
 		 At the time of intubation. 
To determine the incidence of complications like airway trauma, bronchospasm, hypoxia, & oesophageal intubation.  At the time of intubation 
To determine the Percentage of Glottic Opening Visible (POGO score).  At the time of intubation. 
To determine Cormack Lehane grading.  At the time of intubation. 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   17/08/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Endotracheal intubation is an essential skill performed by multiple medical specialists to secure a patient’s airway as well as provide oxygenation and ventilation. There are multiple techniques available, including the visualization of the vocal cords with a (conventional) laryngoscope or video laryngoscope, direct placement of the endotracheal tube into the trachea via cricothyrotomy, and fibreoptic visualization of the vocal cords via the nasal or oral route. The goal of endotracheal intubation in the emergency setting is to secure the patient’s airway and obtain first-pass success. There are many indications for endotracheal intubation, including poor respiratory drive, questionable airway patency, hypoxia, and hypercarbia. These indications are assessed by evaluating the patient’s mental status, conditions that may compromise the airway, level of consciousness, respiratory rate, respiratory acidosis, and level of oxygenation. In the setting of trauma, a Glasgow Coma Scale of 8 or less is generally an indication for intubation. The risks and benefits of endotracheal intubation should be assessed as would be done with any other procedure. Patients whose respiratory status might improve with less invasive methods should be tried on modalities such as non-invasive positive pressure ventilation or other modes of oxygenation. Severe orofacial trauma can obstruct oropharyngeal intubation due to significant bleeding or disruption of the facial and upper airway anatomy. Cervical spine manipulation during intubation can be harmful to patients with spine injury and immobility. In the setting of these clinical situations, other modes of ventilation and oxygenation should be undertaken if the clinical condition allows. If a definitive airway is required, providers should be prepared for the potential of a surgical airway. There are no absolute contraindications to intubation, and the decision to place a definitive airway should take into consideration each patient’s unique clinical condition. Tracheal intubation by video laryngoscope is the most innovative advancement and a completely different experience as compared with conventional Macintosh laryngoscope, and skills needed for the former method of indirect laryngoscopy are very different from those needed for direct laryngoscopy by Macintosh or Miller blade laryngoscopes. The latter method definitely requires training to be an experienced laryngoscopist and tracheal intubator, while in case of video laryngoscopy (VL), even the novices can successfully do laryngoscopy and intubate the trachea. The VL is visualization of an enlarged video image of airway structures. In contrast, using conventional laryngoscopy, anesthesiologists have only a narrow view of the airway structures, which can be further obscured during attempts to pass the endotracheal tube (ETT), and therefore, sometimes the ETT may slip into oesophagus.  A direct laryngoscopy allows visualization of the larynx. It is used during general anaesthesia, surgical procedures around the larynx, and resuscitation. This tool is useful in multiple hospital settings, from the emergency department to the intensive care unit and the operating room. By visualizing the larynx, endotracheal intubation is facilitated. This is an important step for a range of patients who are unable to secure their own airway, including those with altered mental status and those who are undergoing a surgical procedure. When using direct laryngoscopy to secure a patient’s airway, the physician must be well acquainted with the anatomy, indications, contraindications, preparation, equipment, proper technique, personnel, and complications of the procedure for successful endotracheal intubation. 
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