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CTRI Number  CTRI/2021/09/036515 [Registered on: 15/09/2021] Trial Registered Prospectively
Last Modified On: 14/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Other 
Public Title of Study   Comparision Between Conventional Therapy And High Flow Nasal Oxygenation  
Scientific Title of Study   COMPARISON OF CONVENTIONAL THERAPY WITH HIGH FLOW NASAL OXYGENATION IN MANAGEMENT OF HYPERCAPNEIC RESPIRATORY FAILURE 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepak Malviya 
Designation  Professor and HOD 
Affiliation  dr Ram Manohar Lohiya Institute Of medical sciences 
Address  Dr. Ram Manohar Lohiya Institute of Medical Sciences Vibhuti Khand GomtinagarLucknow Lucknow UTTAR PRADESH 226010 India

Lucknow
UTTAR PRADESH
226010
India 
Phone  8176007063  
Fax    
Email  drdm58@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepak Malviya 
Designation  professor and HOD 
Affiliation  dr Ram Manohar Lohiya Institute Of medical sciences 
Address  Dr. Ram Manohar Lohiya Institute of Medical Sciences Vibhuti Khand GomtinagarLucknow Lucknow UTTAR PRADESH 226010 India

Lucknow
UTTAR PRADESH
226010
India 
Phone  8176007063  
Fax    
Email  drdm58@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deepak Malviya 
Designation  Professor and HOD 
Affiliation  Dr. Ram Manohar Lohiya Institute of Medical Sciences 
Address  Dr. Ram Manohar Lohiya Institute of Medical Sciences Vibhuti Khand GomtinagarLucknow Lucknow UTTAR PRADESH 226010 India

Lucknow
UTTAR PRADESH
226010
India 
Phone  8176007063  
Fax    
Email  drdm58@gmail.com  
 
Source of Monetary or Material Support  
Dr RMLIMS LUCKNOW 
 
Primary Sponsor  
Name  Deparment Of Anesthesiology And Critical Care  
Address  Dr. Ram Manohar Lohiya Institute of Medical Sciences Vibhuti Khand GomtinagarLucknow Lucknow UTTAR PRADESH 226010 India  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
none   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR JITENDRA PRATAP SINGH  DR RMLIMS LUCKNOW  ICU 1ST FLOOR Dr. Ram Manohar Lohiya Institute of Medical Sciences Vibhuti Khand GomtinagarLucknow Lucknow UTTAR PRADESH 226010 India
Lucknow
UTTAR PRADESH 
8077230305

drpratapjitendra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J441||Chronic obstructive pulmonary disease with (acute) exacerbation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  hfno group  initial flow of oxygen will be 0.25 L/kg body weight and will be increased up to 1 L/kg body weight,Fio2 will be set at 50% and will be titrared according to SpO2 and patient comfort 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.Informed consent from patient or his legal guardian
2.Age between 40 years to 90 years.
3.Known case of COAD
 
 
ExclusionCriteria 
Details  1.Coexisting hypoxemia (PaO2/FiO2<200)
2.Unconscious patients
3.Those unable to maintain airway because of any neurological reasons
4.Hemodynamically unstable patients
5.Patients with nasal condition affecting the ability to use high frequency nasal cannula-nasal blockage, perforated nasal septum, recent epistaxis etc
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To compare changes in partial pressures of Carbon Dioxide between Conventional oxygen therapy (COT)and High Flow Nasal Oxygenation (HFNO) groups.  To compare changes in partial pressures of Carbon Dioxide between Conventional oxygen therapy (COT)and High Flow Nasal Oxygenation (HFNO) group at base line ,1 hour and 2 hour 
 
Secondary Outcome  
Outcome  TimePoints 
Compare the changes in
i.Partial pressure of oxygen,
ii.Incidence of need for mechanical ventilation,
iii.Time to discharge from ICU,
iv.Time to discharge from hospital,
v.Rate of readmission and time to readmission
 
at zero hour .1 hour and 2 hours 
 
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)   20/09/2021 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

 

Oxygen therapy is one of the commonest intervention performed in ICU. Respiratory failure can be of two types: Type I or hypoxemic Failure because of inadequate oxygen reaching the tissues and Type II or hypercarbic failure because of inadequate carbon dioxide(CO2) transfer. Once the type of respiratory failure is diagnosed, the correct treatment, based on oxygen support and/or ventilation should be instituted(1). The conventional treatment is initially oxygen therapy by various masks, followed by non invasive or invasive mechanical ventilation

High flow nasal oxygenation (HFNO) is a new non-invasive, easy-to-use respiratory device, displaying several advantages over conventional oxygenation systems .It  can deliver warm, humidified flows up to 25  to 60 L/min through soft nasal canula. The active humidification along with warming  promotes physiologic mucociliary clearance and improves fluidity of respiratory secretions, thus, letting the patients to tolerate such high flows. Further, it has been seen that the fraction of inspired oxygen (FiO2) remains stable and reliable as there is minimal losses as well as negligible ambient air entrainment.. Till now there are very few reports, retrospective study(5) and patients involving stable outdoor patients of chronic obstructive airway disease (COAD) (6), or trials used for very short period (6,7) where HFNO was tried in patients of COAD. So, we designed this study to evaluate the effectiveness of HFNO in patients of COAD  with predominantly Hypercapnic ( Type II) respiratory failure requiring ICU admission

Aim: To compare effectiveness of high Flow Nasal Oxygenation in patients with hypercapnic respiratory failure with conventional therapy. Primary objectiveTo compare changes in partial pressures of Carbon Dioxide between Conventional oxygen therapy  (COT)and High Flow Nasal Oxygenation (HFNO) groups.  Secondary Objective: Compare the change in (1)   Partial pressure of oxygen (2) Incidence of need for mechanical ventilation (3)  Time to discharge from ICU (4)Time to discharge from hospital (5)   Rate of readmission and time to readmission.

METHODOLOGY

After obtaining approval from Institute Ethical Committee(IEC 67/19 ref5172 14/01/2020), this study will be conducted in the Intensive Care Unit of Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow. Written informed consent will be obtained from the patient or his nearest kin before enrolling for the study. Patients will have the liberty to withdraw from the study at any point without any adverse influence in his treatment. Patients of known COAD who are admitted because of predominant hypercapnic  respiratory failure fulfilling the inclusive criteria will be enrolled for the study. Hypercapnia will be defined by PaCO 2 â‰¥45 mm Hg. Patients of HFNO will be managed by HFNO, starting with flow rates of 0.25L/kg/min to 1L/kg/min. Data of conventional therapy will be obtained from historical controls.

All patients will be monitored by  ECG, Heart rate(HR), Respiratory Rate(RR), systolic blood pressure(SBP) diastolic blood pressure and mean arterial pressure(MAP)  ,  pH, partial pressures of oxygen, carbon dioxide,  at base line  after instituting NIV/HFNO and will be repeated at 1 hour and 2 hours. Study will terminate after 2 hours or before if condition worsen and other intervention is required.

 


 
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