Body Temperature ChangesNCT05179681
High-Flow Oxygen Preserve Intraoperative Body Temperature
An observational study of Body Temperature Changes, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Body Temperature Changes
- What is being tested?
- Nasal High -Flow Oxygen Therapy
- How many people
- 256 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Jan 2018to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Adult, Older adult
Study population: adult patients undergoing nonintubated video-assisted thoracic surgery (NIVATS) with either a facemask or transnasal humidified rapid-insufflation ventilatory exchange (THRIVE)
Who may be able to join
- 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 kg·m-2), coagulopathy, anatomical deformity or an American Society of Anesthesiology (ASA) classification greater than 3 were excluded.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nasal High -Flow Oxygen Therapy Improves Body Temperature Preservation in Non-intubated Thoracoscopic Surgery
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.
Read the detailed 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
- 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.
- 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.
- 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.
- Conditions
- Body Temperature Changes
- Being tested
- Nasal High -Flow Oxygen Therapy
- Medical subject headings
- Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal High -Flow Oxygen TherapyOther
patients receiving transnasal humidified rapid-insufflation ventilatory exchange
| Study group | Role | What they receive |
|---|---|---|
| patients with non-intubated thoracic surgery | Not described Receives: Other: Nasal High -Flow Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
body temperature changes
the differences of body temperature
Measured: before operations, and arrival at postoperative care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start29 Jan 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Temperature ChangesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179681
- Sponsor's protocol ID
- 201801005RINB
- Status last verified
- Jan 2018
- First submitted
- 25 Jan 2018
- Last updated
- 5 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal High -Flow Oxygen Therapy Improves Body Temperature Preservation in Non-intubated Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT05179681
- Acronym / sponsor ID
- 201801005RINB
- Conditions
- Body Temperature Changes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- 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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with non-intubated thoracic surgery | – | Other: Nasal High -Flow Oxygen Therapy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adult patients undergoing nonintubated video-assisted thoracic surgery (NIVATS) with either a facemask or transnasal humidified rapid-insufflation ventilatory exchange (THRIVE)
Key inclusion criteria (2 listed)
- 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 kg·m-2), coagulopathy, anatomical deformity or an American Society of Anesthesiology (ASA) classification greater than 3 were excluded.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal High -Flow Oxygen Therapypatients receiving transnasal humidified rapid-insufflation ventilatory exchange | Other | patients with non-intubated thoracic surgery |
Primary outcome
body temperature changes
Time frame: before operations, and arrival at postoperative care unit
the differences of body temperature
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Temperature Changes, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body temperature changes (time frame: before operations, and arrival at postoperative care unit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2022.