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Safety and Feasibility of a Novel Transnasal Cooling Device to Induce Normothermia in Febrile Cerebrovascular Patients

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Abstract

Background

Inducing normothermia with surface cooling temperature modulating devices (TMDs) is cumbersome and often associated with significant shivering. We tested the safety and feasibility of a novel transnasal evaporative cooling device to induce and maintain normothermia in febrile patients following ischemic and hemorrhagic stroke.

Methods

A single-center study utilizing the CoolStat® transnasal cooling device was used to achieve core temperature reduction in mechanically ventilated stroke patients with fever (T ≥ 38.3 C) refractory to acetaminophen by inducing an evaporative cooling energy exchange in the nasal turbinates thru a high flow of dehumidified air into the nasal cavity and out through the mouth. Continuous temperature measurements were obtained from tympanic and core (esophageal or bladder) temperature monitors. Safety assessments included continuous monitoring for hypertension, tachycardia, and raised intracranial pressure (when monitored). Otolaryngology (ENT) evaluations were monitored for any device-related nasal mucosal injury with a pre- and post-visual examination. Shivering was assessed every 30 min using the Bedside Shivering Assessment Scale (BSAS). Duration of device use was limited to 8 h, at which time patients were transitioned to routine care for temperature management.

Results

Ten subjects (median age: 54 years, BMI: 32.5 kg/m2, 60% men) were enrolled with normothermia achieved in 90% of subjects. One subject did not achieve normothermia and was later refractory to other TMDs. Median baseline temperature was 38.5 ± 0.1 C, with a reduction noted by 4 h (38.5 ± 0.1 vs 37.3 ± 0.8, P < 0.001) and sustained at 8 h (38.5 ± 0.1 vs 37.1 ± 0.7, P = 0.001). Time to normothermia was 2.6 ± 1.9 h. The median BSAS was 0 (range 0–1) with only 4 episodes necessitating meperidine across 76 h of study monitoring. No treatment was discontinued due to safety concerns. ENT evaluations noted no device-related adverse findings.

Conclusions

Inducing normothermia with a novel transnasal TMD appears to be safe, feasible and not associated with significant shivering. A multicenter trial testing the ability of the CoolStat to maintain normothermia for 24 h is currently underway.

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Funding

This study was funded by the Maryland Industrial Partnerships (MIPS) program.

Author information

Authors and Affiliations

  1. Program in Trauma, Department of Neurology, University of Maryland School of Medicine, Baltimore, USA

    Neeraj Badjatia, Stephanie Sanchez & Hemantkumar Tripathi

  2. Department of Otolaryngology, University of Maryland School of Medicine, Baltimore, USA

    Nidhi Gupta

  3. Department of Nursing, Hood College, Frederick, USA

    Joseph Haymore

  4. Department of Cardiology, The Johns Hopkins Hospital, Baltimore, USA

    Rushil Shah & Harikrishna Tandri

  5. Cool Tech, Inc., Baltimore, USA

    Casey Hannan

Authors
  1. Neeraj Badjatia
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  2. Nidhi Gupta
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  3. Stephanie Sanchez
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  4. Joseph Haymore
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  5. Hemantkumar Tripathi
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  6. Rushil Shah
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  7. Casey Hannan
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  8. Harikrishna Tandri
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Contributions

Conception of the study design done by NB and HT. Data collection was done by JH, SS, RS, and HT. Data analysis and interpretation was done by NB. Drafting of the article was done by NB, SS, and JH. Critical revision of the manuscript was done by CH, HT, NB, JH. All authors approved the final version of this manuscript for publication.

Corresponding author

Correspondence to Neeraj Badjatia.

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Conflict of interest

Harikrishna Tandri is the founder of CoolTech LLC, which is developing a transnasal device for hypothermia. The other authors report no conflict of interests.

Ethical approval/informed consent

The study was approved by the University of Maryland, Baltimore Institutional Review Board. Informed consent for participation in the study was obtained from the legally authorized representative for each study patient.

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Badjatia, N., Gupta, N., Sanchez, S. et al. Safety and Feasibility of a Novel Transnasal Cooling Device to Induce Normothermia in Febrile Cerebrovascular Patients. Neurocrit Care 34, 500–507 (2021). https://doi.org/10.1007/s12028-020-01044-9

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  • DOI: https://doi.org/10.1007/s12028-020-01044-9

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