FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/01/061281 [Registered on: 09/01/2024] Trial Registered Prospectively
Last Modified On: 21/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare two techniques of Intubation through nasal cavity that is traditional nasal Intubation versus Airway plus bougie guided nasal Intubation  
Scientific Title of Study   Comparative Evaluation of Conventional versus nasopharyngeal airway guided bougie technique for nasotracheal intubation in adult patients planned for surgery under general anaesthesia. 
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 SK Singhal 
Designation  Professor 
Affiliation  Pt. B D Sharma PGIMS Rohtak 
Address  Dept. of Anaesthesiology and Critical Care Pt. B D Sharma PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  9416391115  
Fax    
Email  ssinghal12@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bonam Sathish Kumar 
Designation  Junior Resident 
Affiliation  Pt. B D Sharma PGIMS Rohtak 
Address  Dept. of Anaesthesiology and Critical Care Pt. B D Sharma PGIMS Rohtak 124001 India

Rohtak
HARYANA
124001
India 
Phone  7095497558  
Fax    
Email  bonamsathishkumar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bonam Sathish Kumar 
Designation  Junior Resident 
Affiliation  Pt. B D Sharma PGIMS Rohtak 
Address  Dept. of Anaesthesiology and Critical Care Pt. B D Sharma PGIMS Rohtak 124001 India

Rohtak
HARYANA
124001
India 
Phone  7095497558  
Fax    
Email  bonamsathishkumar@gmail.com  
 
Source of Monetary or Material Support  
Institutional Pt. BD Sharma PGIMS Rohtak 
 
Primary Sponsor  
Name  Pt B D Sharma University of Health Sciences PGIMS 
Address  2nd Floor Modular OT Building Department of Anaesthesia and Critical Care Pt. B D Sharma University of Health Sciences PGIMS Rohtak Haryana 
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 Bonam Sathish Kumar  Pt. B D Sharma University of Health Sciences PGIMS   2nd Floor Modular OT Building Dept of Anaesthesiology and Critical Care PGIMS Rohtak
Rohtak
HARYANA 		 7095497558

bonamsathishkumar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics commitee,Pt B D Sharma PGIMS, Rohtak  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  Conventional nasotracheal intubation technique  Preoxygenation will be performed with 100% oxygen for 3 minutes. Induction of anaesthesia will be done with fentanyl(2mcg/kg) and propofol(2mg/kg). After assessing the adequacy of ventilation, atracurium 0.5 mg/kg will be given for neuromuscular blockade.After placing the patient in a sniffing position, direct laryngoscopy with a conventional Macintosh laryngoscope will be done, and the best glottic view will be obtained. A lubricated tracheal tube will be inserted in the more patent nare, and the tube will be advanced through the pharynx past the vocal cords under Macintosh laryngoscope visualization. If the passage of tube through nares is not possible, other nare will be used. If passage of the tracheal tube through the glottis is unsuccessful, either optimal external laryngeal manipulation or Magills forceps will be used to align the tube with the vocal cords. The tracheal tube will then be advanced into the trachea. The Macintosh laryngoscope will be removed and tracheal tube cuff will be inflated. Appropriate placement will be confirmed via chest auscultation and the presence of persistent square wave capnograph.If intubation is not successful after first attempt a smaller size endotracheal tube will be used for second attempt. If second attempt fails, patient will be intubated using Nasopharyngeal airway and bougie technique. If both the techniques fail, airway will be managed as per the attending Anaesthesiologist discretion.  
Intervention  NPA guided bougie technique for nasotracheal intubation.   All patients will undergo preoperative examination for nasal patency by the ENT team. Informed written consent will be taken from the patients after explaining the purpose and protocol of the study.Xylometazoline nasal drops will be instilled in both nostrils in the premedication room 30 minutes before shifting to the operation theatre.Upon arrival in the operating room, nasal drops will be instilled again.After securing the peripheral intravenous line with an 18-gauge cannula, preoxygenation will be performed with 100% oxygen for 3 minutes. Induction of anaesthesia will be done with fentanyl(2mcg/kg) and propofol(2mg/kg). After assessing the adequacy of ventilation, atracurium 0.5 mg/kg will be given for neuromuscular blockade. Patient will be ventilated for 3 minutes using 2% sevoflurane in 100% oxygen.After placing the patient in sniffing position, appropriate-size nasopharyngeal airway will be introduced in the patent nare. If the passage of nasopharyngeal airway through nare is not possible, other nare will be used. Macintosh laryngoscope blade will then be inserted in the oral cavity and the best laryngeal view will be noted. The bougie will be placed through the nasopharyngeal airway, coude tip end first, with coude tip facing anteriorly. While watching with the conventional Macintosh laryngoscope, the bougie will be advanced to the glottic opening. If needed, rotation of the bougie and/or external laryngeal manipulation will be used to align the bougie with the vocal cords. If these maneuvers are unsuccessful in placing bougie in the glottic opening, Magill‟s forceps will be used.If the bougie is not placed in two attempts,it will be considered as a failure of technique and intubation will be done using conventional technique. After the bougie is placed in or through the glottic opening, it will be rotated by 180°, such that the Coude tip faces posteriorly. The bougie will be then advanced in the trachea until resistance is met (distal hold-up sign). Laryngoscopy will be continued and the nasopharyngeal airway will be removed over the bougie. Using Seldinger‟s technique, the tracheal tube will be threaded over the bougie and advanced under laryngoscopic visualization. If the tube gets caught on glottic structures, it will be rotated. Once placed, the tracheal tube cuff will be inflated, and laryngoscope will be removed.Appropriate tracheal tube placement will then be confirmed with bilateral chest auscultation and persistent square wave capnography. If intubation is not successful after first attempt a smaller size endotracheal tube will be used for second attempt. If second attempt fails, patient will be intubated using a conventional technique. If both techniques fail, the airway will be managed using an alternate method. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of either sex, aged between 18 and 60 years belonging to ASA I & II posted for elective surgery under general anaesthesia. 
 
ExclusionCriteria 
Details  1. Refusal to consent.
2. Anticipated difficult airway.
3. Pregnant females.
4. History of recurrent epistaxis.
5. History of bleeding diathesis, Nasal trauma.
6. History of rhinoplasty or septoplasty.
7. Patients with nasal passage stenosis, nasal deformity, polyp, nasopharyngeal tumor.
8. Patients on anticoagulants, antiplatelets. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare both techniques in terms of Nasopharyngeal trauma.   After Securing the Endotracheal tube Nasopharyngeal Trauma will be asses using 4×4 inch folded Gauze by Anaesthetist 
 
Secondary Outcome  
Outcome  TimePoints 
1.Ease of insertion of the endotracheal tube into nasopharynx
2.Intubation time.
3.Number of attempts required for successful nasotracheal intubation.
4.Maneuvers required for successful nasotracheal intubation.
5.Success rate.  		 After Intubation  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   15/01/2024 
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="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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
Modification(s)  		 This Study is to compare conventional technique with nasopharyngeal airway guided Bougie technique for nasotracheal intubation in adult patients planned for surgery under general anaesthesia, in terms of Nasopharyngeal Trauma, Ease of insertion of the endotracheal tube into nasopharynx, Intubation time, Number of attempts required, Maneuvers required and Success rate.  
Close