Hemodynamic InstabilityNCT03653910
Effect-site Concentration of Remifentanil for Double-lumen Tubes Intubation: Airtraq VS Macintosh Laryngoscope
A study testing Airtraq and Macintosh in people with Hemodynamic Instability and Intubation Complication, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
The 50% effective concentration of remifentanil by target controlled infusion was not determined for inhibiting the haemodynamic response during double-lumen tube (DLT) intubation. Previous study showed that Airtraq videolaryngoscope provided more stable haemodynamics than Macintosh for double-lumen tube intubation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodynamic Instability, Intubation Complication
- What is being tested?
- Airtraq and Macintosh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2018to 17 May 2019
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical status of I-II
- Patients aged 18-65 years
- BMI 18-35 kg/m2
- Elective pulmonary surgery under general anesthesia to double-lumen tubes intubation
- Mallampati classifications Ⅰ-Ⅱ
Who cannot join
- Emergency operation
- Anticipated difficult airway or history of intubation difficulties
- Be allergic to any of the drugs used in the experiment, or have a history of drug allergy
- Preoperative use of analgesic, sedative and other drugs
- Uncontrolled hypertension and heart disease
- Have a history of heavy smoking and alcohol abuse, serious drug abuse, and severe systemic infections
- There are severe mental and nervous system symptoms, and patients cannot cooperate with the study, such as language comprehension disorder, mental illness, etc
- Other clinical trials were conducted within 3 months prior to inclusion in the study
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Effect-site Concentration of Remifentanil for Inhibiting Cardiovascular Responses to Double-lumen Tube Intubation With Airtraq Videolaryngoscopy: a Comparative Study With Macintosh Laryngoscopy
The 50% effective concentration of remifentanil by target controlled infusion was not determined for inhibiting the haemodynamic response during double-lumen tube (DLT) intubation. Previous study showed that Airtraq videolaryngoscope provided more stable haemodynamics than Macintosh for double-lumen tube intubation. In this study, the investigators will compare the 50% effective concentration of remifentanil between Airtraq videolaryngoscope and Macintosh laryngoscope for inhibiting haemodynamic responses during DLT intubation.
Read the detailed description
Dixon "up-and-down" method was used to determine 50% effective concentration of remifentanil by target controlled infusion for inhibiting the haemodynamic responses during DLT intubation with Airtraq videolaryngoscope or Macintosh laryngoscope.
- Conditions
- Hemodynamic Instability, Intubation Complication
- Being tested
- Airtraq, Macintosh
- Keywords
- double-lumen tube intubation, remifentanil, target controlled infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirtraqDevice
Airtraq is a kind of videolaryngoscope for intubation
MacintoshDevice
Macintosh is a traditional laryngoscope for intubation
| Study group | Role | What they receive |
|---|---|---|
| Airtraq | Experimental | Patients received DLT intubation by Airtraq videolarygoscope Receives: Device: Airtraq |
| Macintosh | Active comparator | Patients received DLT intubation by Macintosh laryngoscope Receives: Device: Macintosh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remifentanil TCI effect site concentration
preestablish remifentanil TCI effect site concentration(ng/ml)
Measured: through study completion, an average of 20 min
Secondary outcomes (3)
mean arterial pressure
mean arterial pressure in mmHg
Measured: at entering the operation room(T1), at immediately before DLT intubation(T2), at immediately after DLT intubtion(T3), at 1 minute(T4)/2 minutes (T5)/3 minutes(T6) after DLT intubation
heart rate
heart rate in bpm
Measured: at entering the operation room(T1), at immediately before DLT intubation(T2), at immediately after DLT intubtion(T3), at 1 minute(T4)/2 minutes (T5)/3 minutes(T6) after DLT intubation
Narcotrend index
Narcotrend index in Arabic numerals
Measured: at entering the operation room(T1), at immediately before DLT intubation(T2), at immediately after DLT intubtion(T3), at 1 minute(T4)/2 minutes (T5)/3 minutes(T6) after DLT intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start3 Sep 2018
- Primary completion10 May 2019
- Study completion17 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenlong Yao, Huazhong University of Science and Technology
- Investigators
- Ailin Luo, M.D., Study chair, alluo@tjh.tjmu.edu.cn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653910
- Sponsor's protocol ID
- TJMZK20180713
- Status last verified
- May 2019
- First submitted
- 6 Aug 2018
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect-site Concentration of Remifentanil for Inhibiting Cardiovascular Responses to Double-lumen Tube Intubation With Airtraq Videolaryngoscopy: a Comparative Study With Macintosh Laryngoscopy
- ClinicalTrials.gov ID
- NCT03653910
- Acronym / sponsor ID
- TJMZK20180713
- Conditions
- Hemodynamic Instability, Intubation Complication
- Keywords
- double-lumen tube intubation, remifentanil, target controlled infusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 17 May 2019 (actual)
- First posted
- 31 Aug 2018 (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.
The 50% effective concentration of remifentanil by target controlled infusion was not determined for inhibiting the haemodynamic response during double-lumen tube (DLT) intubation. Previous study showed that Airtraq videolaryngoscope provided more stable haemodynamics than Macintosh for double-lumen tube intubation. In this study, the investigators will compare the 50% effective concentration of remifentanil between Airtraq videolaryngoscope and Macintosh laryngoscope for inhibiting haemodynamic responses during DLT intubation.
Detailed description
Dixon "up-and-down" method was used to determine 50% effective concentration of remifentanil by target controlled infusion for inhibiting the haemodynamic responses during DLT intubation with Airtraq videolaryngoscope or Macintosh laryngoscope.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Airtraq | Experimental | Device: AirtraqPatients received DLT intubation by Airtraq videolarygoscope |
| Macintosh | Active comparator | Device: MacintoshPatients received DLT intubation by Macintosh laryngoscope |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- American Society of Anesthesiologists physical status of I-II
- Patients aged 18-65 years
- BMI 18-35 kg/m2
- Elective pulmonary surgery under general anesthesia to double-lumen tubes intubation
- Mallampati classifications Ⅰ-Ⅱ
Key exclusion criteria (8 listed)
- Emergency operation
- Anticipated difficult airway or history of intubation difficulties
- Be allergic to any of the drugs used in the experiment, or have a history of drug allergy
- Preoperative use of analgesic, sedative and other drugs
- Uncontrolled hypertension and heart disease
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 |
|---|---|---|
| AirtraqAirtraq is a kind of videolaryngoscope for intubation | Device | Airtraq |
| MacintoshMacintosh is a traditional laryngoscope for intubation | Device | Macintosh |
Primary outcome
Remifentanil TCI effect site concentration
Time frame: through study completion, an average of 20 min
preestablish remifentanil TCI effect site concentration(ng/ml)
3 secondary outcomes
mean arterial pressure
Time frame: at entering the operation room(T1), at immediately before DLT intubation(T2), at immediately after DLT intubtion(T3), at 1 minute(T4)/2 minutes (T5)/3 minutes(T6) after DLT intubation
heart rate
Time frame: at entering the operation room(T1), at immediately before DLT intubation(T2), at immediately after DLT intubtion(T3), at 1 minute(T4)/2 minutes (T5)/3 minutes(T6) after DLT intubation
Narcotrend index
Time frame: at entering the operation room(T1), at immediately before DLT intubation(T2), at immediately after DLT intubtion(T3), at 1 minute(T4)/2 minutes (T5)/3 minutes(T6) after DLT intubation
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 21 May 2019.
- Individual participant dataSharing planned: No
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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.
Ailin Luo, M.D. study chair
alluo@tjh.tjmu.edu.cn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airtraq and Macintosh in people with Hemodynamic Instability and Intubation Complication, run by Huazhong University of Science and Technology at 1 site in China.
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 5 inclusion and 8 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 21 May 2019. 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 China. 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?
Remifentanil TCI effect site concentration (time frame: through study completion, an average of 20 min). 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 21 May 2019.