| 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
|
|
|
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
|
|
|
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 |
|
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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. |