| 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
|
|
|
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
|
|
|
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
|
|
|
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 objective; To 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 ≥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.
|