| 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
|
|
|
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
|
|
|
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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