Hypothermia; Anesthesia, Hypothermia, Newborn, Hypothermia, Sequela
Conditions
Brief summary
The purpose of this study is to evaluate the best method for keeping patients warm during cesarean deliveries and the effect of temperature change on the patient and baby
Interventions
DEVICEPre op upper body forced air warming (32˚C)
Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
DEVICEPre op lower body forced air warming (32˚C)
lower body forced air warming at ambient (32˚C) for at least 30 minutes
DEVICEPre op fluids (45˚C)
fluids from warmed cabinet set at 45˚C
DEVICEIntra op upper body forced air warming (32˚C)
Use of upper body forced air warming intra-operative at ambient (32˚C)
DEVICEIntra op fluids at room temperature
IV fluids at room temperature
DEVICEIntra op upper body forced air warming at (32˚C)
upper body forced air warming intra-operative at ambient (32˚C)
DEVICEIntra op upper body forced air warming at (42˚C)
upper body forced air warming intra-operative at ambient (42˚C)
DEVICEIntra op lower body forced air warming at (32˚C)
Lower body forced air warming intra-operative at ambient (32˚C)
DEVICEIntra op lower body forced air warming at (42˚C)
Lower body forced air warming intra-operative at ambient (42˚C)
DEVICEIntra op fluid (42˚C)
IV fluids with hotline fluid warmer set at 42˚C
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* scheduled for elective cesarean section under neuraxial anesthesia * singleton pregnancy
Exclusion criteria
* gestational age of less than 37 week * emergency cesarean
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Core Body Temperature | preoperative/beginning of surgery, postoperative/end of surgery (4 hours after anesthesia) | — |
| Number of Women With Hypothermia | preoperative/beginning of surgery ,postoperative/end of surgery (4 hours after anesthesia) | Hypothermia is indicated as core temperature \< 36 °C |
| Neonate Status as Determined by Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score | 1 minutes after birth, 5 minutes after birth | The Apgar score is determined by evaluating the newborn baby on each of five criteria (appearance, pulse, grimace, activity, respiration) on a scale from zero to two, then summing the five values obtained. The total score ranges from zero to 10. A higher score indicates a better outcome. |
| Umbilical Artery pH | 10 minutes after birth | — |
| Maternal Coagulopathy | end of surgery (4 hours after anesthesia) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Shivering (Severity) | on arrival to Post anesthesia Care Unit (PACU) [about 4 hours after anesthesia] | Degree of shivering is measured from 0(no shivering)-3(total body shivering), a higher score indicates greater shivering. |
| Number of Patients That Need Meperidine | on arrival to PACU [about 4 hours after anesthesia] | — |
| Maternal Thermal Comfort | end of surgery (4 hours after anesthesia) | Maternal thermal comfort has a total score range from 0 to 10,a higher number indicating more thermal comfort |
| Perioperative Blood Loss | end of surgery (4 hours after anesthesia) | — |
| Hospital Length of Stay | Time of admission to time of discharge (about 72 hours after surgery) | — |
| Neonate Blood Sugar Level | 10 minutes after birth | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORStacy Norrell, MD
The University of Texas Health Science Center, Houston
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 29.87 years STANDARD_DEVIATION 6.2 |
| American Society of Anesthesiology (ASA) Classification ASA I | 0 Participants |
| American Society of Anesthesiology (ASA) Classification ASA II | 3 Participants |
| American Society of Anesthesiology (ASA) Classification ASA III | 3 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 6 | 0 / 10 | 0 / 6 |
| other Total, other adverse events | 0 / 10 | 0 / 6 | 0 / 10 | 0 / 6 |
| serious Total, serious adverse events | 0 / 10 | 0 / 6 | 0 / 10 | 0 / 6 |
Outcome results
None listed