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CTRI Number  CTRI/2021/12/038825 [Registered on: 22/12/2021] Trial Registered Prospectively
Last Modified On: 21/12/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Best ventilatory strategy for head and neck oncological surgeries 
Scientific Title of Study   Best ventilatory strategy - A comparative study between three modes of ventilation in prolonged onco-surgery. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nitesh Goel 
Designation  Consultant Anaesthesia 
Affiliation  Rajiv Gandhi Cancer institute 
Address  Department of Anaesthesia. Old building, 3rd floor. Rajiv Gandhi Cancer Institute and research centre. Sector-5, Rohini New Delhi-110085
Department of Anaesthesia. Old building, 3rd floor. Rajiv Gandhi Cancer Institute and research centre. Sector-5, Rohini New Delhi-110085
North West
DELHI
110085
India 
Phone  9717773292  
Fax    
Email  drniteshgoel@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nitesh Goel 
Designation  Consultant Anaesthesia 
Affiliation  Rajiv Gandhi Cancer institute 
Address  Department of Anaesthesia. Old building, 3rd floor. Rajiv Gandhi Cancer Institute and research centre. Sector-5, Rohini New Delhi-110085
Department of Anaesthesia. Old building, 3rd floor. Rajiv Gandhi Cancer Institute and research centre. Sector-5, Rohini New Delhi-110085
North West
DELHI
110085
India 
Phone  9717773292  
Fax    
Email  drniteshgoel@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nitesh Goel 
Designation  Consultant Anaesthesia 
Affiliation  Rajiv Gandhi Cancer institute 
Address  Department of Anaesthesia. Old building, 3rd floor. Rajiv Gandhi Cancer Institute and research centre. Sector-5, Rohini New Delhi-110085
Department of Anaesthesia. Old building, 3rd floor. Rajiv Gandhi Cancer Institute and research centre. Sector-5, Rohini New Delhi-110085
North West
DELHI
110085
India 
Phone  9717773292  
Fax    
Email  drniteshgoel@gmail.com  
 
Source of Monetary or Material Support  
Rajiv Gandhi Cancer Institute 
 
Primary Sponsor  
Name  Rajiv Gandhi Cancer Institute and research centre 
Address  Sector-5, Rohini New Delhi -110085 
Type of Sponsor  Research institution and hospital 
 
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 Nitesh Goel  Rajiv Gandhi Cancer Institute and research centre  Department of Anaesthesia. Old building, 3rd floor. Sector-5, Rohini New Delhi-110085
North West
DELHI 		 9717773292

drniteshgoel@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional review board Rajiv Gandhi Cancer institute and research centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C04||Malignant neoplasm of floor of mouth, (2) ICD-10 Condition: C102||Malignant neoplasm of lateral wallof oropharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Change in ventilatory mode  3 modes of ventilation, that is volume control, pressure control and volume-autoflow will analysed 
Comparator Agent  Pressure control ventilation  Patients will be ventilated at a pressure to achieve tidal volume of 7ml/kg, PEEP of 5 and modifying respiratory rate to maintain end tidal carbon dioxide between 35 to 40 mmofHg 
Comparator Agent  Volume control autoflow  Patients will be ventilated with tidal volume of 7ml/kg, PEEP of 5 and modifying respiratory rate to maintain end tidal carbon dioxide between 35 to 40 mmofHg 
Comparator Agent  Volume control ventilation  Patients will be ventilated with tidal volume of 7ml/kg, PEEP of 5 and modifying respiratory rate to maintain end tidal carbon dioxide between 35 to 40 mmofHg 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  BMI between 25 to 29.9
6-10 hrs duration surgeries
ASA 1-3
 
 
ExclusionCriteria 
Details  Patients with respiratory ailments like bronchitis, asthma etc.
Cardiac patients with stent, CABG
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Recording of dynamic compliance at different time points in all the ventilatory modes and comparing them.
More the dynamic compliance,better is the mode. 		 15 minutes interval 
 
Secondary Outcome  
Outcome  TimePoints 
Recording and comparing resistance, peak and plateau airway pressure.  15 minutes interval 
 
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)   26/12/2021 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drniteshgoel2014@gmail.com].

  6. For how long will this data be available start date provided 01-06-2023 and end date provided 31-05-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   This will be a prospective study, observational, randomized study where patients undergoing prolonged surgeries of 6- 10 hrs duration will be enrolled into the study. After taking a written informed consent, 60 patients will be recruited into the study. Recruited patients will be randomly distributed on chit based system in three groups based on ventilatory modes- volume control, pressure control and volume controlled autoflow mode of ventilation. Ventilator settings will be done with a target tidal volume of 7ml/kg and frequency of ventilation will be adjusted to maintain an end tidal carbon dioxide between 35-45 mm of Hg. Intraoperatively recordings will be done for respiratory mechanics (end tidal carbon dioxide, tidal volume, minute ventilation, positive end-expiratory pressure, lung dynamic compliance, airway pressures) and ABG analysis (Fio2, PaO2/Fio2, ph, Paco2, Po2, lactate).
Respiratory parameters will be recorded every 15 minutes whereas ABG analysis will be done twice per case soon after induction and before reversal as per routine protocol in long surgeries. Rest of anesthetic and surgical management will be done as per usual standardized protocols.

 
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