| 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 |
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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 |
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Scientific Title of Study
|
Peri-intubation oxygenation techniques to minimize the degree of hypoxia in patients with hypoxemic respiratory failure in intensive care unit.
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| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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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 |
|
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Source of Monetary or Material Support
|
| Sri Devaraj Urs Academy of Higher Education and Research, Tamaka, Kolar |
|
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Primary Sponsor
|
| Name |
Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
Tamaka, Kolar 563101 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee, SDUMC,Kolar |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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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, |
|
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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 |
|
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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..
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Not Applicable |
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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 |
|
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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 |
|
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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" |
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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" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
none yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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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 apneaâ€, 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. |