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CTRI Number  CTRI/2018/09/015747 [Registered on: 18/09/2018] Trial Registered Prospectively
Last Modified On: 14/09/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to evaluate the effect of 2 different methods of oxygen supplementation in preventing fall in oxygen saturation during intubation in ICU 
Scientific Title of Study   Peri-intubation oxygenation techniques to minimize the degree of hypoxia in patients with hypoxemic respiratory failure in intensive care unit.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sumanth T 
Designation  Assistant professor 
Affiliation  SDUAHER, Kolar 
Address  Department of Anaesthesiology, SDUAHER, Tamaka, KOLAR

Kolar
KARNATAKA
563101
India 
Phone  9535974751  
Fax    
Email  tom2f4u@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sumanth T 
Designation  Assistant professor 
Affiliation  SDUAHER, Kolar 
Address  Department of Anaesthesiology, SDUAHER, Tamaka, KOLAR

Kolar
KARNATAKA
563101
India 
Phone  9535974751  
Fax    
Email  tom2f4u@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sumanth T 
Designation  Assistant professor 
Affiliation  SDUAHER, Kolar 
Address  Department of Anaesthesiology, SDUAHER, Tamaka, KOLAR

Kolar
KARNATAKA
563101
India 
Phone  9535974751  
Fax    
Email  tom2f4u@gmail.com  
 
Source of Monetary or Material Support  
Sri Devaraj Urs Academy of Higher Education and Research, Tamaka, Kolar 
 
Primary Sponsor  
Name  Sri Devaraj Urs Academy of Higher Education and Research 
Address  Tamaka, Kolar 563101 
Type of Sponsor  Private 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 Suresh Kumar N  RL Jalappa Hospital  Intensive Care Unit, Dept of Anaesthesiology
Kolar
KARNATAKA 
9008222550

drskumar6@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Ethics Committee, SDUMC,Kolar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J40-J47||Chronic lower respiratory diseases, (2) ICD-10 Condition: J09-J18||Influenza and pneumonia, (3) ICD-10 Condition: J95-J95||Intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified, (4) ICD-10 Condition: J20-J22||Other acute lower respiratory infections,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nasal Cannula Group with Oxygen insufflation at 15 L/min   Apneic oxygenation provided through Nasal Prongs with Oxygen Flow at 15 L/min during the time of intubation in hypoxic patients in ICU 
Intervention  Nasopharyngeal Airway Group   Apneic oxygenation along with Continuous positive airway pressure(CPAP) delivered through Nasophayngeal airway during intubation of hypoxix patients in ICU 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with Type I (Hypoxemic) respiratory failure, without any hemodynamic compromise.
Hypoxemic respiratory failure is defined as respiratory rate > 30 breaths/min and an FiO2 requirement of 50% or more to obtain oxygen saturation of at least 90%, and PaO2 to FiO2 ratio below 300 mmHg, in the 4 hours before inclusion. Hemodynamic compromise is defined as MAP < 65 mmHg without inotropic support
 
 
ExclusionCriteria 
Details  1.Patients with anticipated difficult airway as evaluated using MACOCHA score
2.Pregnant or breast feeding woman
3.Contraindications to nasopharyngeal airway insertion like nasopharyngeal obstruction, coagulopathies etc..
4.Contraindications to NIV such as patients with claustrophobia, full stomach and GCS<8 etc..
5.Contraindications to Ketamine and Succinylcholine such as raised intracranial tension, ischemic heart disease, hyperkalemia etc..
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare CPAP through Nasopharyngeal airway with O2 through Nasal prongs as a mode of Peri-intubation oxygenation for reducing the degree of desaturation while intubating patients with hypoxemic respiratory failure in ICU  18 months 
 
Secondary Outcome  
Outcome  TimePoints 
: To assess the complications related to intubation of patients with hypoxemia in the ICU:
1. Degree of intubation difficulty as graded on IDS ( Intubation difficulty score)
2. Degree of hemodynamic compromise ( percentage change in HR & MAP)
3. Incidence of Bradycardia or tachyarrhythmias 
18 months 
 
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)   25/09/2018 
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   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

   Patients admitted to Intensive care units (ICUs) with hypoxemic (Type I) respiratory failure often require respiratory support in the form of intubation and mechanical ventilation. Drop in SpO2 to below 70% (Critical hypoxia) while performing intubation increases the risk of arrhythmias, hemodynamic compromise, hypoxic brain injury and death1.  Securing the airway rapidly without critical hypoxia or aspiration is often a challenge for intensivists. Moreover the margin of safety for desaturation is lesser with critically ill patients when compared to patients without pre-existing hypoxia.

              Preoxygenation is the standard recommendation before intubating patients in ICU because of the following reasons:

1.      Preoxygenation allows a safety buffer during period of intubation. It extends the duration of “Safe apnea”, defined as the time until a patient reaches a saturation of 88-90%, to allow for placement of a definitive airway.

2.       Rapid sequence induction (RSI) has been commonly employed in ICU, taking into account the high risk of aspiration of gastric contents in these patients2.

 Several Preoxygenation techniques have been developed to prevent or limit the risk of desaturation during intubation. Non-invasive ventilation (NIV) for preoxygenation of patients with acute hypoxemic respiratory failure is associated with less hypoxemia when compared to preoxygenation with a traditional face mask with reservoir bag3. However, NIV mask has to be taken off after preoxygenation in order to perform orotracheal intubation. The hypoxemic patient doesn’t receive oxygen during this period, precipitating rapid desaturation, especially in patients with difficult airway.

    “Apneic oxygenation” has been described which allows continued oxygenation during the period of apnea. Apneic oxygenation extends the duration of safe apnea when used after administration of sedatives or muscle relaxants. Many strategies have been developed to provide apneic oxygenation such as NO DESAT (nasal oxygen during efforts securing a tube) using a nasal cannula set at 15 L/min, THRIVE (Trans-nasal humidified rapid-insufflation with ventilatory exchange) using a high flow nasal cannula at 60 L/min4

Though apneic oxygenation can be provided with nasal cannula, a patent airway is required for oxygen to reach the hypo pharynx and be entrained into the trachea. A nasopharyngeal airway can accomplish this airway patency especially in patients with obesity and Obstructive sleep apnea. Furthermore, studies have shown that HFNC (High Flow Nasal Cannula) oxygen therapy generates a flow dependant positive airway pressure by increasing end-expiratory lung volume, suggesting a possible associated alveolar recruitment.

   Nasopharyngeal airway as a means to allow apneic oxygenation and to enhance the continued positive airway pressure (CPAP) thereby promoting alveolar recruitment, has not been assessed and the possible benefits over simple nasal cannula with 15 L/min O2 flow for apneic oxygenation has to be established.

Therefore we undertake this study to compare whether providing CPAP through  Nasopharyngeal airway as a means of apneic oxygenation is effective when compared to traditional means of apneic oxygenation using Nasal prongs at 15 L/min while intubating hypoxic patients in ICU.

 
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