| CTRI Number |
CTRI/2024/11/076421 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
30/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A new cannulation technique for extracorporeal oxygenation for respiratory failure |
|
Scientific Title of Study
|
Veno - left atrial extracorporeal membrane oxygenation for respiratory failure |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandeep Chauhan |
| Designation |
Professor and Chief of Cardiothoracic Centre |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Cardiac Anaesthesia and Critical Care
Cardiothoracic Centre
All India Institute of Medical Sciences
New Delhi
New Delhi DELHI 110029 India |
| Phone |
01126593503 |
| Fax |
|
| Email |
sdeep61@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Suruchi Hasija |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Cardiac Anaesthesia and Critical Care
Cardiothoracic Centre
All India Institute of Medical Sciences
New Delhi
New Delhi DELHI 110029 India |
| Phone |
01126593423 |
| Fax |
|
| Email |
suruchi_hasija@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Suruchi Hasija |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Cardiac Anaesthesia and Critical Care
Cardiothoracic Centre
All India Institute of Medical Sciences
New Delhi
New Delhi DELHI 110029 India |
| Phone |
01126593423 |
| Fax |
|
| Email |
suruchi_hasija@hotmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar
New Delhi-110029 |
| 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 Sandeep Chauhan |
All India Institute of Medical Sciences, New Delhi |
CTVS ICU, Department of Cardiac Anaesthesia and Critical Care, Cardiothoracic Centre
New Delhi DELHI |
01126593503
sdeep61@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J960||Acute respiratory failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
NA |
| Intervention |
Veno-left atrial cannulation for ECMO |
Cannulation:
VV-ECMO cannulation will be performed in the ICU / fluoroscopy suite under transthoracic echocardiography (TTE) / transesophageal echocardiography (TEE) guidance. The use of fluoroscopy ensures proper positioning of the wires and the cannula. Before initiating the procedure, the patient will be deeply sedated and paralyzed, a central venous line and an arterial catheter will be secured to allow adequate hemodynamic monitoring as well as infusion of volume fluids and/or vasopressors required during the procedure.
After correct placement, the cannulae will be firmly fixed. A chest X-ray will be performed at the end of the procedure to detect potential complications (hemothorax and/or pneumothorax) and to confirm the correct placement of the cannulae.
Heparinization:
The initial bolus dose of heparin will be 100 units/kg administered prior to the introduction of the cannula. This will be followed by infusion at 10-20 units/kg/min. Activated clotting time (ACT) will be repeated every three hours. The target ACT levels will be maintained between 180-200 seconds.
ECMO Settings:
Pump flow rate will be set around 100-150 ml/kg/min. Initially the pump will be started at the flow rate of 20 ml/kg/min and then gradually increased after every 5-10 minutes by 10 ml/kg/min up to the desired flow rate, depending upon the patient’s haemodynamic state.
The initial sweep gas flow to blood flow ratio to 0.5:1 will be increased up to 1.5:1 depending on pCO2 level in blood.
FiO2 setting will vary between 21% 100%.
Clinical parameter targets:
Mean arterial pressure: 70-90 mm of Hg
Arterial oxygen saturation 85%
Mixed venous oxygen saturation 65%
Hemoglobin: 12-14 gm%
Hematocrit: 35- 40%
Platelet count 50000/cm3
Complication
If proposed cannulation technique fails, i.e., adequate oxygenation cannot be maintained or adequate flows cannot be given, then immediately V-LA ECMO will be shifted to conventional VV ECMO followed by VVA ECMO if required. In first scenario the return cannula will be withdrawn from left atrium to right atrium at the level of SVC. In the second scenario, if the patient becomes hemodynamically unstable then an additional return cannula will be placed in the axillary artery or femoral artery.
Weaning from V-LA ECMO
Consideration will be given to decannulation after 6 hours of stable native ventilation with adequate gas exchange without oxygenator gas flow. Heparin will not be ceased until decannulation, when a small dose of protamine (50-100 mg/kg) will be given if required. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Hypoxemic and/or hypercapnic respiratory failure |
|
| ExclusionCriteria |
| Details |
advanced systemic disease, terminal illness, mechanical ventilation for more than 7 days, contraindication to anticoagulants, sepsis, multiorgan failure, cardiogenic shock |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the feasibility of veno-left atrial extracorporeal membrane oxygenation for respiratory failure. |
Recovery/death |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the efficiency of oxygenation delivery with this technique.
2.To demonstrate the absence of recirculation with this technique.
3.To determine the duration of ECMO and ICU stay. |
Cessation of ECMO.
Discharge from ICU. |
|
|
Target Sample Size
|
Total Sample Size="5" Sample Size from India="5"
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)
|
01/01/2025 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 development of ECMO technology allows a new approach for the intensive care management of acute cardiac and/or respiratory failure in adult patients who are not responsive to conventional treatment. The ECMO circuit is composed of three main components including a pump, oxygenator, and heat exchanger. Venous blood is drained and then pumped through the heating component, the oxygenator, and then returned to the patient. The circuit blood is returned to an artery (venoarterial ECMO [VA ECMO]) or a vein (venovenous ECMO [VV ECMO]). VV ECMO can be performed with different cannulation strategies. While VV ECMO circuits usually include the cannulation of two vessels, femoro-jugular or femoro-femoral, the use of a dual-lumen single cannula is also possible for VV-ECMO support. The oxygenated blood mixes with the native venous circulation such that the resultant arterial oxygen tension and saturation represents a mixture of the oxygenated extracorporeal blood and the unoxygenated venous blood that passes through the resting native lungs. However, by virtue of being positioned in the venous side of the vascular system, these cannulation techniques have the inherent issue of recirculation and mixing. Recirculation is a phenomenon wherein reinjected oxygenated blood is withdrawn by the drainage venous cannula without passing through the systemic circulation. This recirculation fraction is not available for systemic oxygenation and may contribute to ineffective ECMO and hypoxemia. With typical ECMO flows of 3–4 L/min, some of the blood flows through the ECMO circuit and some is shunted past the ECMO circuit into the diseased native lung. This leads to a mixing of well-oxygenated ECMO blood with poorly oxygenated shunted blood, which lowers total oxygen saturation. We hypothesize that a higher oxygen delivery to the systemic circulation may be achieved by returning oxygenated blood directly into the left atrium (LA). It may also achieve greater degree of lung rest and recovery as the lower ventilatory settings may be needed consequent to reduced pulmonary blood flow. Also, improved oxygen delivery to the heart may prevent myocardial dysfunction and the need to convert to VA ECMO. Therefore, we propose the V-LA cannulation technique for ECMO wherein the drainage cannula will be placed via the femoral vein and the LA return cannula will be placed by trans-septal puncture via the internal jugular vein (IJV). |