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Novel device for automating exchange transfusions through umbilical venous route in neonates

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Abstract

Manually performed double-volume exchange transfusion (DVET) is tedious, error-prone, and may incur the risk of embolism. We aimed to develop a device that automates the DVET procedure performed through the umbilical venous route. We evaluated changes in blood passing through the device during DVET. We developed an electro-mechanical device with accessories (tubing and valve assembly) to perform a complete DVET. It comprises two syringes driven by a common pump that moves back and forth to withdraw aliquots of the patient’s blood and infuse equal volumes of donor blood. In tandem, it draws donor blood from a blood bank bag and pushes the patient blood drawn from the previous cycle into a waste bag, respectively. One-way duckbill valves and a two-way pinch valve ensure the separation of the donor and patient blood. A sensor detects bubbles and clots. A dashboard displays set and measured parameters. We tested the accuracy of the delivered flow rate and volume, electrical safety, embolus detection, and changes in hematological and biochemical values. The delivered flow and volume were within 5% of the set parameters. All electrical safety parameters were within normal limits. The sensor consistently detected microbubbles and clots. There were no clinically significant differences in laboratory parameters between samples drawn directly from the blood bank bag and drawn from the exit port at 80, 100, 120, and 160 s with a fixed aliquot volume.

Conclusions: Our prototype of a novel device can safely automate a DVET. Further trials of this device are warranted.

What is Known:

• Double volume exchange transfusion is often performed manually, but this is time-consuming and error-prone.

• Previous attempts at automation were not widely adopted because they involved inserting two catheters and did not have mechanisms to prevent embolism.

What is New:

• This novel device fully automates double volume exchange transfusions through a single-lumen umbilical venous catheter.

• It prevents air and clot embolism and has a screen for input and output parameters and alarms.

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Abbreviations

AC:

Alternating current

DC:

Direct current

DVET:

Double volume exchange transfusion

LCD:

Liquid crystal display

LED:

Light emitting diode

USA:

United States of America

UVC:

Umbilical venous catheter

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Acknowledgements

Supported by a grant from the Department of Science and Technology (DST), India, through the biomedical instrumentation hub, PGIMER (DST sanction order IDP/MED/03/2016, dated May 7, 2018).

Funding

Department of science and technology,government of India, IDP/MED/03/2016 dated 7 May 2018, IDP/MED/03/2016 dated 7 May 2018, IDP/MED/03/2016 dated 7 May 2018, IDP/MED/03/2016 dated 7 May 2018, IDP/MED/03/2016 dated 7 May 2018, IDP/MED/03/2016 dated 7 May 2018, IDP/MED/03/2016 dated 7 May 2018, IDP/MED/03/2016 dated 7 May 2018, IDP/MED/03/2016 dated 7 May 2018.

Author information

Author notes

  1. Sanjeev Verma and Sourabh Dutta equally contributed to this study and are co-senior authors.

Authors and Affiliations

  1. Council of Scientific and Industrial Research- Central Scientific Instruments Organization (CSIR-CSIO), Chandigarh, India

    Arindam Chatterjee, Sanjeev Verma, Sarbjeet Singh & Gurinderjit Singh

  2. Department of Transfusion Medicine, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, India

    Ratti Ram Sharma, Suchet Sachdev & Prateek Bhatia

  3. Neonatology Unit, Department of Pediatrics, PGIMER, Sector 12, Chandigarh, 160023, India

    Sourabh Dutta

  4. Department of Pediatrics, PGIMER, Chandigarh, India

    Savita Attri & Prateek Bhatia

Authors
  1. Arindam Chatterjee
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  2. Sanjeev Verma
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  3. Sourabh Dutta
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  4. Sarbjeet Singh
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  5. Gurinderjit Singh
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  6. Ratti Ram Sharma
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  7. Suchet Sachdev
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  8. Savita Attri
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  9. Prateek Bhatia
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Contributions

Arindam Chatterjee, Sanjeev Verma, Sarbjeet Singh, and Gurinderjit Singh designed the device and its accessories, conducted experiments with the device, collected the data, and drafted the initial manuscript. Sourabh Dutta conceptualized the device and the study, provided clinical inputs for designing the device, planned the laboratory work, and reviewed and revised the manuscript. Ratti Ram Sharma and Suchet Sachdev provided inputs regarding banked blood for designing the device, coordinated ex vivo experiments with blood bank blood, and reviewed and revised the manuscript. Savita Attri and Prateek Bhatia coordinated the hematological and biochemical experiments, provided laboratory inputs for revising the design of the device, and reviewed and revised the manuscript. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

Corresponding author

Correspondence to Sourabh Dutta.

Ethics declarations

Ethics approval

The Institute Ethics Committee granted ethical approval to conduct ex vivo experiments on adult donor blood in blood bank bags issued by the Department of Transfusion Medicine (IEC-08/2018–988, dated October 13, 2018).

Consent to participate

No human subjects were enrolled in the study.

Conflict of interest

The authors declare no competing interests.

Additional information

Communicated by Daniele De Luca.

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Chatterjee, A., Verma, S., Dutta, S. et al. Novel device for automating exchange transfusions through umbilical venous route in neonates. Eur J Pediatr 182, 1229–1238 (2023). https://doi.org/10.1007/s00431-022-04791-3

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  • DOI: https://doi.org/10.1007/s00431-022-04791-3

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