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CTRI Number  CTRI/2024/11/076251 [Registered on: 04/11/2024] Trial Registered Prospectively
Last Modified On: 09/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of oral tube versus nasal tube in preventing drop in oxygen levels before introduction of tube into the throat for assisted breathing. 
Scientific Title of Study   Comparison of Apneic oxygenation via modified Buccal Ring Adair and Elwyn Tube (RAE) versus Nasal Cannula (NC) in patients requiring Endotracheal intubation in Emergency Department. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr GOKULA RAMAN K 
Designation  PG student 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER) 
Address  Room No 5, First floor, Emergency Medicine Department, ED division, EMSD building, Dhanvantri nagar, JIPMER

Pondicherry
PONDICHERRY
605006
India 
Phone  6369586641  
Fax    
Email  drgokularaman@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manu Ayyan 
Designation  Associate Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  No 7, Emergency Medicine division, First Floor EMSD Building, Jawaharlal Institute of Postgraduate Medical Education and Research DHANVANTRI NAGAR

Pondicherry
PONDICHERRY
605006
India 
Phone  9846556133  
Fax    
Email  manuayyan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manu Ayyan 
Designation  Associate Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  No 7, Emergency Medicine division, First Floor EMSD Building, Jawaharlal Institute of Postgraduate Medical Education and Research DHANVANTRI NAGAR


PONDICHERRY
605006
India 
Phone  9846556133  
Fax    
Email  manuayyan@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri Nagar, Puducherry. 605006 India 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Jawaharlal Institute of Postgraduate Medical Education and Research DHANVANTRI NAGAR PUDUCHERRY 605006 India 
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 GOKULA RAMAN K  Jawaharlal Institute of Postgraduate Medical Education and Research  No-3, Research Division, Emergency Medicine Department, First Floor EMSD Building
Pondicherry
PONDICHERRY 
6369586641

drgokularaman@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES JIPMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Buccal Oxygenation group  Apneic oxygenation is given through modified Buccal RAE tube from the start of Apnea till intubation 
Comparator Agent  Nasal Oxygenation group  Apneic oxygenation is given through nasal cannula from the start of Apnea till intubation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Any Adult patients presenting to the Emergency Department with hypoxia requiring rapid sequence intubation 
 
ExclusionCriteria 
Details  1. Age less than18 years
2. Pregnant Women
3. Patients who are not properly preoxygenated to the standard RSI protocol of a goal of 3 minutes with 100 percent FiO2.
4. Patients intubated in cardiac or traumatic arrest
5. Hypotension SBP less than 90mmHg
6. Patients intubated without an apneic period-awake intubation
7. The treating emergency physician feels a specific approach to preoxygenation is required between induction, paralysis to successful intubation e.g. a patient in whom provider felt a need to require bag- valve-mask ventilation prior to laryngoscopy, a patient with unstable facial fractures in whom nasal canula cannot be applied 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the incidence of hypoxia (SPO2 ≤ 93% or fall in SPO2 ≥ 5%) from start of apnoea (time of NMB agent administration) until 2 minutes after successful intubation.  Preoxygenation to 2 minutes after successful intubation 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the PaO2 values at the start of Apnea period and 2 minutes after successful intubation between the two groups.  Preoxygenation to 2 minutes after successful intubation 
To compare lowest arterial oxygen saturation measured by continuous pulse oximetry (SPO2) between induction and 2 minutes after successful endotracheal tube placement.  Preoxygenation to 2 minutes after successful intubation 
To compare the incidence of severe hypoxaemia (SPO2 less than 80%) from start of apnoea (time of NMB agent administration) until 2 minutes after successful intubation  Preoxygenation to 2 minutes after successful intubation 
4) To compare the First pass success rate (proportion of successful intubation on first laryngoscopy attempt)  Preoxygenation to 2 minutes after successful intubation 
 
Target Sample Size   Total Sample Size="152"
Sample Size from India="152" 
Final Enrollment numbers achieved (Total)= "152"
Final Enrollment numbers achieved (India)="152" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/11/2024 
Date of Study Completion (India) 31/03/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

      The primary objective of Airway management is to ensure adequate oxygenation and ventilation by securing a endotracheal tube without critical hypoxia or aspiration. Preoxygenation in the Emergency Department involves bringing the patients saturation as close to 100% as possible, to denitrogenate the residual capacity of the lungs (maximizing oxygen storage in the lungs) and maximally oxygenate the bloodstream. Conventional preoxygenation techniques may not be adequate in providing a safe apnea period in patients at high risk for desaturation or when an unanticipated difficult airway arises. Apneic oxygenation has been used as an adjunct to Rapid Sequence Intubation (RSI) which helps in reducing the desaturation. The principle behind the apneic oxygenation involves by providing continuous supply of oxygen to the upper airway, a reservoir of oxygen is maintained during apnea and this differential rate between alveolar oxygen absorption and carbon dioxide excretion generates a negative pressure gradient, which results in a ventilatory mass flow of gas from the upper respiratory tract into the lungs. Several types of oxygen devices used for apneic oxygenation includes Nasal cannula, High Flow Nasal Cannula, Nasopharyngeal oxygen insufflation, Buccal RAE Tube, Ventilator assisted preoxygenation.

           Several meta-analyses of apneic oxygenation studies have demonstrated a clinical benefit with the use of apneic oxygenation during emergent RSI. Apneic oxygenation serve as an non invasive adjunct to endotracheal intubation to decrease the incidence of hypoxemia, morbidity and mortality. Numerous studies of apneic oxygenation are described in the literature using modified laryngoscopes, nasopharyngeal catheters and nasal prongs. Nasal approaches in particular are increasing in popularity but are difficult in certain patient groups like trauma. Furthermore, some nasal catheter techniques (nasopharyngeal) have been associated with gastric rupture. Apneic oxygenation through Buccal oxygen administration via a modified Ring-Adair-Elwyn (RAE) tube would effectively extend safe apnea during prolonged laryngoscopy in obese patients.

           Various apenic oxygenation techniques have been compared to asses which could an ideal preoxygenation technique. Buccal versus nasal route has been compared in controlled operating room settings to find out safe apnea time, which concluded that buccal oxygenation via a modified RAE tube gives safe Apnea time higher than the Nasal cannula. Obesity, Trauma and many factors influence the apneic oxygenation through nasal route. Apneic oxygenation via nasal route has two disadvantages, one is that it has a longer route to the laryngeal inlet where we are targeting the flow of oxygen another is that any secretion, blood along the route can hinder the flow of oxygen. Another possible issue is that hypoxic patients might have their mouth open and this might lead to escape of at least some part of flow through the mouth when flow is delivered through nasopharynx. We hypothesize that the Buccal oxygenation can bypass the nasopharyngeal area and deliver oxygen directly in the pharyngeal inlet. There are no studies published till date regarding possibility of using buccal oxygenation as an alternate route for preventing incidence of hypoxia post endotracheal intubation during RSI. Buccal oxygenation with RAE tube could be an alternative to nasal cannula for apneic oxygenation during rapid sequence intubation in hypoxic patients presenting to emergency department. This method might be even the only possible oxygenation method in patients with maxillofacial injuries and obstructed nasal passage. 

 
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