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CTRI Number  CTRI/2025/12/098665 [Registered on: 08/12/2025] Trial Registered Prospectively
Last Modified On: 05/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing use of giving oxygen with minimal pressure vs high flow oxygen without pressure in improving oxygen storage in lungs before giving general anaesthesia in patients posted for laparoscopic surgeries. 
Scientific Title of Study   Preoxygenation with Pressure Support Ventilation (PSV) mode versus high flow oxygen with Zero End Expiratory Pressure (ZEEP) on end tidal Oxygen in rapid sequence intubation (RSI). 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priscilla S 
Designation  Junior Resident 
Affiliation  Christian Medical College Vellore 
Address  Department of Anaesthesia Christian Medical College Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9787691370  
Fax    
Email  priscillasagayaraj@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Tony Thomson Chandy 
Designation  Professor 
Affiliation  Christian Medical College Vellore 
Address  Department of Anaesthesia Christian Medical College Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9500242412  
Fax    
Email  tonythomson@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  Rahavi 
Designation  Assisstant Professor 
Affiliation  Christian Medical College Vellore 
Address  Department of Anaesthesia Christian Medical College Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9442763053  
Fax    
Email  rahavirajendran@gmail.com  
 
Source of Monetary or Material Support  
Christian Medical College Vellore 632004 Tamilnadu India 
 
Primary Sponsor  
Name  Priscilla S 
Address  Department of Anaesthesia Christian Medical College Vellore 
Type of Sponsor  Other [self] 
 
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 
Priscilla S  Christian Medical College Vellore  Department of Anaesthesia Department of General surgery Deapartment of Hepatobiliary surgery
Vellore
TAMIL NADU 
9787691370

priscillasagayaraj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Preoxygenation with high flow oxygen  Preoxygenation with 100 percent oxygen will be given using a closed breathing circuit for three minutes. 
Intervention  Preoxygenation with Pressure Support Ventilator Mode  preoxygenation will be done in Pressure support ventilator mode with pressure support of 2 cm of H2O and PEEP of zero for three minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients aged 18 to 80 years posted for laparoscopic surgeries
ASA 1 and 2 
 
ExclusionCriteria 
Details  ASA 3 and above
Patients with Respiratory Illness
Edentulous Patients
Pregnant patients
Emergency procedures
Patients with Difficult Intubation
Patients with Increased Intracranial Pressure
Patients with Recent Gastric Surgery
Patients with Pharyngeal and Esophageal surgery
Refusal by Patients
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To measure the End tidal Oxygen at the end of 3 minutes of preoxygenation comparing between pressure support ventilation and high flow oxygen with zero PEEP


 
To measure the End tidal Oxygen at the end of 3 minutes of preoxygenation comparing between pressure support ventilation and high flow oxygen with zero PEEP


 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the Oxygen Saturation at the end of intubation between two techniques of Preoxygenation.
 
5 mins from the starting of preoxygenation 
To compare partial pressure of oxygen between arterial (PaO2) and venous (PvO2) blood prior to oxygenation   
To measure PvO2 after intubation   
To compare the tidal volumes during preoxygenation with normal inspiratory effort   
To compare the End Tidal Oxygen (EtO2) at the end of intubation will be noted   
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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)   17/12/2025 
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="6"
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  
Rapid Sequence Intubation is a procedure that aims to reduce the incidence of pulmonary aspiration during airway management. Rapid Sequence Intubation is performed by administering an induction agent followed by a neuromuscular blocker. Rapid sequence intubation secures the airway, minimizing the risk of aspiration and facilitating intubation in critically ill patients. Effective preoxygenation is essential for enhancing oxygen reserves and boosting functional residual capacity. There are different techniques employed in the administration of preoxygenation which include breathing 100percent Oxygen at normal tidal volume for 3 to 5 minutes and taking eight vital capacity breaths in 1 minute. A newer technique that is helpful for better preoxygenation is Non Invasive Ventilation with the Pressure Support Ventilation technique. Patients posted for laparoscopic surgery will be recruited for the study. Patients who consent to the study will be randomized using computer generated randomization to allocate each patient into the Interventional group which is group A and the Control group that is group B. Patients in group A will receive preoxygenation using pressure support ventilation mode set at 2 cm H2O with a PEEP of zero. Conversely in group B preoxygenation will be given with 100percent high flow oxygen for 3 minutes. Before the preoxygenation procedure the patient will undergo the collection of one arterial blood gas and one venous blood gas while breathing room air. Following the preoxygenation an additional venous blood gas will be collected after intubation. Adequacy of oxygenation will be compared using PaO2 values from the collected samples. Appropriate descriptive and analytical statistics will be used to establish the study objectives.

 
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