N/A
N=14
Heated Humidified Breathing Circuit Rewarming in Hypothermic Post Cardiopulmonary Bypass Patients.
Hypothermia · Rewarming
Bottom Line
View on ClinicalTrials.gov: NCT03697122 ↗Enrolled (actual)
14
Serious AEs
14.3%
Results posted
Jul 2020
Primary outcome: Primary: Time to Normothermia — 4.4 hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Heated Humidified Breathing Circuit and Forced Air Blanket (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Normothermia |
4.4 | — |
| SECONDARY Time to Extubation |
5.4 | — |
| SECONDARY Coagulopathy as Measured by Need for Transfusion of Blood Product |
— | — |
| SECONDARY Metabolic Derangement as Measured by Time to Normal pH |
0.4 | — |
| SECONDARY Number of Subjects With Abnormal Coagulopathy as Measured by Laboratory Assessment of Prothrombin Time |
12 | — |
| SECONDARY Number of Subjects With Abnormal Coagulopathy as Measured by Laboratory Assessment of INR |
12 | — |
| SECONDARY Number of Subjects With Abnormal Coagulopathy as Measured by Laboratory Assessment of Act Partial Thromboplastin Time |
10 | — |
| SECONDARY Number of Subjects With Abnormal Coagulopathy as Measured by Laboratory Assessment of Fibrinogen. |
5 | — |
| SECONDARY Number of Subjects With Abnormal Coagulopathy as Measured by Laboratory Assessment of Platelet Count |
7 | — |
Summary
Hypothermia on admission to the intensive care unit (ICU) following cardiopulmonary bypass (CPB) is common. The investigators propose that rewarming hypothermic (≤ 35 C) patients admitted to the intensive care unit following procedures using CPB with heated humidified breathing circuits (HHBC) in addition to conventional forced air warming blankets will shorten time to normothermia. Secondarily it may shorten time to extubation, improve coagulopathy, and metabolic derangements seen with hypothermia.
Eligibility Criteria
Inclusion Criteria
- Admission to intensive care unit following surgical procedure involving cardiopulmonary bypass.
- Admission temperature ≤ 35.0 C.
Exclusion Criteria
- Patients placed on extracorporeal membrane oxygenation intra-operatively, or during first 24 hours after ICU admission.
- Any additional surgical procedures in the first 24 hours days after initial surgery e.g. Chest exploration for bleeding, Open Chest, Non-cardiac surgery such as colectomy for ischemic gut, etc.
Data sourced from ClinicalTrials.gov (NCT03697122). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.