Accidental Hypothermia in Drowning-related OHCA

Sponsor
Prehospital Center, Region Zealand (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05908630
Collaborator
(none)
317
7.1

Study Details

Study Description

Brief Summary

This study aims to report mortality and neurological outcome 180 days after drowning incident in patients with accidental hypothermia vs normothermia following drowning-related OHCA in Denmark during a six-year period from 2016-2021.

Condition or Disease Intervention/Treatment Phase
  • Other: Hypothermia

Detailed Description

The incidence of accidental hypothermia in patients with out-of-hospital cardiac arrest (OHCA) due to drowning is prevalent. Accidental hypothermia is known to decrease oxygen consumption and hypoxic brain damage in patients with OHCA, but may result from prolonged submersion times, which is shown to increase drowning mortality and morbidity. However, many case reports present extraordinary instances of hypothermic patients with drowning-related OHCA surviving with a good neurological outcome despite prolonged submersion times. A larger, retrospective study is warranted to accurately investigate the role of accidental hypothermia in patients with drowning-related OHCA.

This study is a nationwide, retrospective cohort study with 180-days follow-up from 2016-2021 comparing survival and neurological outcome 180 days after drowning incident in normothermic (≥35C) vs hypothermic (<35C) patients with drowning-related OHCA. A total of 317 patients have been identified by the Danish Drowning Formula and manually validated (Breindahl et al, 2023, unpublished data). Prehospital data from the DCAR will be linked to in-hospital data using the patients' unique civil registration number and presented the "Utstein style". The primary outcome is composite of mortality or poor neurological outcome 180 days after drowning incident (modified Rankin Scale score > 3). Secondary outcomes include hospital length of stay (continuous), intensive care unit admission (binary) and length of stay (continuous), need for ECLS (binary) and duration (continuous), need for mechanical ventilation (binary) and duration (continuous), survival to hospital discharge, and 30-day survival.

The investigators expect to provide evidence on the role of accidental hypothermia in drowning-related OHCA to support evidence-based guidelines and improve clinical decision-making in the future.

Study Design

Study Type:
Observational
Anticipated Enrollment :
317 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The Role of Accidental Hypothermia in Drowning-related Out-of-hospital Cardiac Arrest: A Danish Six-year Observational Cohort Study
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Normothermic drowning patients with OHCA.

First in-hospital temperature measurement (using any probe) within 6 hours after hospital admission ≥35C.

Hypothermic drowning patients with OHCA.

First in-hospital temperature measurement (using any probe) within 6 hours after hospital admission <35C.

Other: Hypothermia
Accidental hypothermia is defined as: "an involuntary drop in core body temperature <35C"

Outcome Measures

Primary Outcome Measures

  1. Survival or poor neurological outcome [180 days after drowning incident.]

    The primary outcome is a composite of mortality or poor neurological outcome 180 days after drowning incident according to the Utstein style

Secondary Outcome Measures

  1. Hospital length of stay [Immediately after hospital discharge]

    Continuous

  2. Intensive care unit admission [Immediately after hospital discharge]

    Binary

  3. Intensive care unit length of stay [Immediately after hospital discharge]

    Continuous

  4. Need for ECLS [Immediately after hospital discharge]

    Binary

  5. Duration of ECLS [Immediately after hospital discharge]

    Continuous

  6. Need for mechanical ventilation [Immediately after hospital discharge]

    Binary

  7. Duration of mechanical ventilation [Immediately after hospital discharge]

    Continuous

  8. Survival to hospital discharge [Immediately after hospital discharge]

    Binary

  9. 30-day survival [30 days after drowning incident]

    Binary

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Inclusion Criteria - Drowning persons with:
  • OHCA registered in the DCAR from 2016-2021.

  • An in-hospital temperature measurement (using any probe) within 6 hours after hospital admission.

Exclusion Criteria - Drowning persons will be excluded if:
  • They have obvious signs of irreversible death (decapitation, decomposition, post-mortem lividity, post-mortem rigidity).

  • They are declared dead on scene.

  • They have a valid Do-Not-Attempt-Resuscitation order or other code status orders limiting life-sustaining therapies.

  • They do not have a valid civil registration number.

  • They do not have a valid in-hospital temperature measurement (any probe within 6 hours after hospital admission).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Prehospital Center, Region Zealand

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Niklas Breindahl, Medical Doctor, Prehospital Center, Region Zealand
ClinicalTrials.gov Identifier:
NCT05908630
Other Study ID Numbers:
  • KBNB_DH
First Posted:
Jun 18, 2023
Last Update Posted:
Jun 18, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 18, 2023