Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05179681 |
| Other study ID # |
201801005RINB |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 29, 2018 |
| Est. completion date |
December 31, 2019 |
Study information
| Verified date |
January 2018 |
| Source |
National Taiwan University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Background: Hypothermia would increase the risk of bleeding, infection, cardiac complications
and delay recovery. The transnasal humidified rapid-insufflation ventilatory exchange
(THRIVE) could not only provide the larger oxygen preserve but also humidified high flow.
However, Objectives: We wanted to investigated whether the humidified high flow of THRIVE
would affect perioperative body temperature (BT).
Patients and methods: We reviewed the medical records of adult patients undergoing
non-intubated video-assisted thoracic surgery (NIVATS) have been retrospective reviewed. All
patients have received force air warming. Multiple linear regression analysis was used to
determine which factors were associated with BT loss.
Expected result: In patients receiving NIVATS under force air warming, the use of THRIVE may
provide more efficiently BT preserve, although the patients with oxygen mask could have
acceptable BT preservation. The more BT loss is associated with the advanced age and higher
BMI level. The anesthetic duration is not associated with the BT loss.
Description:
The goal:In this retrospective study, we aimed to investigate that patients undergoing NIVATS
with the use of the THRIVE have better BT than these patients without use the THRIVE.
Methods
A. Study Subjects:
In this retrospective study, the adult patients undergoing nonintubated video-assisted
thoracic surgery (NIVATS) with a planned mask or transnasal humidified rapid-insufflation
ventilatory exchange (THRIVE) were retrospectively reviewed for patients from the beginning
of 2016 to the end of 2017.
Inclusion criteria:
1.Patients who will receive scheduled NOVATS surgery under general anesthesia Patients who
met the following criteria were considered candidates for NIVATS: tumours smaller than 6 cm,
peripheral lesions, no evidence of severe adhesion, no evidence of chest wall, diaphragm, or
main bronchus involvement.
Exclusion criteria:
1.Patients who had potential or confirmed airway complications such as bronchial tumor or
hemothorax, morbid obesity (body mass index [BMI] greater than 35), coagulopathy, anatomical
deformity or an American Society of Anesthesiology (ASA) classification greater than 3 were
excluded.
B. Study Protocol The adult patients undergoing nonintubated video-assisted thoracic surgery
(NIVATS) with a planned mask or transnasal humidified rapid-insufflation ventilatory exchange
(THRIVE) were retrospectively reviewed for patients from March 2016 to June 2017. All
surgical procedures were performed by a single thoracic surgical team using identical
clinical protocols, care patterns and perioperative orders. Demographic data and operation
outcomes were obtained from the patients' chart review. The core body temperature data,
including the last body temperature in the ward before sending to the OR and the first body
temperature in the post-anaesthesia care unit (PACU), was obtained from the online records.
C. Methods:
Patients in the mask and thrive groups were all warmed during the whole perioperative periods
(beginning in the patients into the operative room (OR) until discharge from OR) using the
3M™ Bair Hugger™ Normothermia System to cover the patients' upper bodies. The temperature of
intravenous fluids were kept around 18。C. Below 35。C was selected to define hypothermia
because it has been well accepted in the literature as being physiologically significant.
Patients' tympanic temperature as the core temperature was measured on the ward, just before
induction and in the OR, and in the postoperative anesthesia unit. For temperature
measurements, an infrared tympanic ear thermometer (BRAUN ThermoScan Pro 4000' Welch Allyn,
Skaneateles Falls, NY) was used.
Statistical Analysis Categorical data were analysed using the chi-square test. Numerical data
were presented as means ± standard deviation unless otherwise specified. Student's t-test was
performed to compare the sample means in two independent groups. Paired t-test was performed
to compare preoperative and postoperative body temperature change in the THRIVE and mask
groups.
Stepwise multivariate linear regression was performed to determine the independent effect of
difference body temperature between preoperative and postoperative periods. Variables were
included in the model. Age, BMI, using THRIVE or not, intravenous fluid during the operative
period, anesthetic duration, and potential confounding factors, which are differed between
two groups, were analyzed. A separate stepwise linear regression was performed including
patients in the THRIVE and mask groups. A p value < 0.05 was deemed significant. Statistical
analysis was performed using SPSS 17 statistical software (SPSS, Inc., Chicago, IL, USA).
Study endpoints and sample size calculation The difference between the preoperative and
postoperative temperature measurements was compared.
Sample size for the primary outcome end point was determined using the G-power 3 statistical
package. Given the SD of core body temperature is around 0.4。C in the general surgical
population, a moderate effect size corresponds to a mean temperature difference of 0.2。C
between groups. There were 212 patients needed.
