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CTRI Number  CTRI/2024/09/074324 [Registered on: 25/09/2024] Trial Registered Prospectively
Last Modified On: 17/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical trial to study efficacy of Pre Oxygenation with cushioned tight fitting face mask in 20 degrees head up position versus High flow nasal oxygen in supine position in elective surgeries -A Prospective,Randomised,Controlled Study. 
Scientific Title of Study   Pre Oxygenation with cushioned tight fitting face mask in 20 degrees head up position versus High flow nasal oxygen in supine position in elective surgeries -A Prospective,Randomised,Controlled Study. 
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 M Suryakumar Rupika 
Designation  MBBS Post Graduation MD Anaesthesiology 
Affiliation  Sri Venkateswara Institute of Medical Sciences 
Address  Department of Anaesthesiology SVIMS Tirupati Chittoor District Andhra pradesh 517507

Chittoor
ANDHRA PRADESH
517507
India 
Phone  7416859479  
Fax    
Email  drrupika093@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr N Hemanth 
Designation  Professor Department of Anaesthesiology SVIMS  
Affiliation  Sri Venkateswara Institute of Medical Sciences 
Address  Department of Anaesthesiology SVIMS Tirupati Chittoor District Andhra pradesh 517507

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9440285634  
Fax    
Email  hemanthn1973@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr N Hemanth 
Designation  Professor Department of Anaesthesiology SVIMS  
Affiliation  Sri Venkateswara Institute of Medical Sciences 
Address  Department of Anaesthesiology SVIMS Tirupati Chittoor District Andhra pradesh 517507

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9440285634  
Fax    
Email  hemanthn1973@gmail.com  
 
Source of Monetary or Material Support  
Sri Venkateswara Institute of Medical Sciences SVIMS Tirupati 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
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 N Hemanth  Sri Venkateswara Institute of Medical Sciences  Department of Anaesthesiology Sri Venkateswara Institute of Medical Sciences SVIMS Tirupati 517507
Chittoor
ANDHRA PRADESH 		 9440285634

hemanthn1973@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee SVIMS,Tirupati  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 
Intervention  Pre oxygenation with Cushioned Tight Fitting Face Mask in 20 degrees Head up Position  Pre oxygenation is done with Cushioned Tight Fitting Face Mask in 20 degrees Head up Position for 2 minutes 45seconds before induction 
Comparator Agent  Pre oxygenation with High Flow Nasal Oxygen in Supine Position  Pre oxygenation is done with High Flow Nasal Oxygen in Supine Position for 2 minutes 45 seconds before induction  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.American society of anaesthesiologists physical status(ASA) I,II
2.Patients of age 18to 65 years.
3. Body mass index (BMI) less than 30kg/m2.
4.Patients undergoing Elective surgeries under general anaesthesia.
 
 
ExclusionCriteria 
Details  1.Patient refusal to give consent.
2.Pregnant women.
3.Patient having Nasal obstruction.
4.Baseline oxygen saturation less than 96% while breathing on room air in sitting position .
5.Anticipated Difficult Airway Mallampati grade [MPG]greater or equal to 3
6.Previous allergy to drugs used in standard anaesthetic regimen.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To record the time to desaturate to 92% from the onset of apnoea.  Time taken by patient from point of visual confirmation of apnoea (T0) to point of desaturation to 92% (T1)  
 
Secondary Outcome  
Outcome  TimePoints 
1.To record lowest Saturation of peripheral oxygen (SPO2) during first five breaths immediately post procedure.
2.To record Highest End Tidal Carbondioxide (ETCO2) during first five breaths immediately post procedure.
3.Number of intubation attempts.
4.Usage of special laryngoscopes other than Macintosh Blade number 3.
5. Cormack lehane grading.
6. Signs of regurgitation in pharynx while intubation.
7.Tolerance of patient to the device subjective discomfort Likert scale
 		 Lowest SPO2,Highest ETCO2 recorded in 1,2,3,4,5 breaths after connecting to oxygen 
 
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)   01/10/2024 
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="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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  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 (Others) -  .

  6. For how long will this data be available start date provided 24-09-2024 and end date provided 24-09-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Endotracheal Intubation  requires an anaesthetic induction process which results in loss of consciousness and neuromuscular block which causes hypoventilation and apnoea. This carries a risk of hypoxia which  is further exacerbated in difficult endotracheal intubation. Routine practice of preoxygenation before induction of anaesthesia is recommended as a delay in oxygenation may not be anticipated.

The goal of preoxygenation with 100% oxygen before induction is to extend time to desaturation by replacing nitrogen with oxygen and increase oxygen stores. Preoxygenation increases total body oxygen stores from 1.2 litres(L) before oxygenation to 3.2 L at 1minute and 4.8 L at 3 minutes.

Oxygen is commonly  delivered by a cushioned face mask at 15 L/min. An alternative method is delivery of humidified oxygen via High flow nasal cannula (HFNC)(inspiredTM O2FLO,Vincent Medical Manufacturing Co.Ltd ,Hong kong.) . High flow nasal cannula is a oxygenation device which can deliver upto 60L/min of humidified  and heated gas with 100% Fraction of inspired oxygen(Fio2).

The efficacy of preoxygenation is improved by placing the patient in 45 degrees head up position as compared to supine ,but repositioning of patient is needed to avoid exacerbation of arterial hypotension and to allow securing airway. This manoeuvre may also facilitate passive regurgitation of gastric contents and pulmonary aspiration . We adopted the 20 degrees head up position during preoxygenation and induction which was initially proposed by S. Lane et al. This position allows for improved oxygenation and intubation without alteration in position.

In this study , we aim to compare two different methods of preoxygenation .We theorised that preoxygenating patient with face mask(Group M) in 20 degrees position of patient during induction will prolong the apnoea time significantly than in patients preoxygenated with HFNC (Group N) in supine position.

 

 
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