Coronary Disease Undergoing CABGPhase 4NCT01682707
Assessment of Hemodynamic Response During Intubation Between Rigid Laryngoscopy and Track Light in Coronary Patients
A Phase 4 study testing laryngoscopy and track light in people with Coronary Disease Undergoing CABG, run by Federal University of Juiz de Fora at 1 site in Brazil.
Trial summary
Opioids provide greater patient comfort during intubation, but are not able to abolish completely the release adrenergic hormones during the laryngoscopy, which may cause undesirable hemodynamic changes. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Coronary Disease Undergoing CABG
- What is being tested?
- laryngoscopy and track light
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2010to Mar 2010
- Phase
- Phase 4
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- coronary disease ASA 2 e 3 using beta-blockers
Who cannot join
- emergency surgery arrythmia other antiarrythmic drugs
Trial locations and contacts
1 site in 1 country.
Brazil1 site
National Institute of Cardiology / Ministry of Health
Rio de Janeiro, Rio de Janeiro, 22240-005
About this study
Official title: Randomized Clinical Trials to Compare the Hemodynamic Response During Intubation Between Rigid Laryngoscopy and Track Light in Coronary Patients Undergoing CABG
Opioids provide greater patient comfort during intubation, but are not able to abolish completely the release adrenergic hormones during the laryngoscopy, which may cause undesirable hemodynamic changes.
In this study the investigators selected two techniques commonly used for intubation, laryngoscopy and track light, so the investigators can verify which intubation techniques provides less hemodynamic changes in coronary patients under standard anesthesia induction.
- Conditions
- Coronary Disease Undergoing CABG
- Being tested
- laryngoscopy, track light
- Keywords
- intubation, coronary disease, hemodynamic response, anesthesia with tracheal intubation, assessment of hemodynamic response
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laryngoscopyProcedure or surgery
Also called rigidy laryngoscopy,
tracheal intubation with two different techniques, track light and laryngoscopy.
track lightProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Laryngoscopy | Active comparator | Laryngoscopy Track Light teaqueal intubation Receives: Procedure: laryngoscopy |
| Track Light | Active comparator | Not described Receives: Procedure: track light |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemodynamic response
tracheal intubation with track light release less adrenergic hormones than laryngoscopy intubation
Measured: patient prepare (baseline), 1min after induction, 5 min after induction, 1 min after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startFeb 2010
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Disease Undergoing CABGStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Juiz de Fora
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcello F Salgado Filho, MD, Federal University of Juiz de Fora
- Investigators
- Marcello F Salgado filho, MD, Principal investigator, Federal University of Juiz de Fora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682707
- Sponsor's protocol ID
- CAAE-0021.0.185.000-09
- Status last verified
- Apr 2012
- First submitted
- 1 Apr 2010
- Last updated
- 11 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nishiyama T, Misawa K, Yokoyama T, Hanaoka K. Effects of combining midazolam and barbiturate on the response to tracheal intubation: changes in autonomic nervous system. J Clin Anesth. 2002 Aug;14(5):344-8. doi: 10.1016/s0952-8180(02)00370-7.
PubMed 12208438Nora FS, Klipel R, Ayala G, Oliveira Filho GR. [Remifentanil: does the infusion regimen make a difference in the prevention of hemodynamic responses to tracheal intubation?]. Rev Bras Anestesiol. 2007 Jun;57(3):247-60. doi: 10.1590/s0034-70942007000300003. Portuguese.
PubMed 19466360Almeida MC, Martins RS, Martins AL. [Tracheal intubation conditions at 60 seconds in children, adults and elderly patients.]. Rev Bras Anestesiol. 2004 Apr;54(2):204-11. doi: 10.1590/s0034-70942004000200007. Portuguese.
PubMed 19471727
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trials to Compare the Hemodynamic Response During Intubation Between Rigid Laryngoscopy and Track Light in Coronary Patients Undergoing CABG
- ClinicalTrials.gov ID
- NCT01682707
- Acronym / sponsor ID
- CAAE-0021.0.185.000-09
- Conditions
- Coronary Disease Undergoing CABG
- Keywords
- intubation, coronary disease, hemodynamic response, anesthesia with tracheal intubation, assessment of hemodynamic response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federal University of Juiz de ForaUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 11 Sep 2012 (estimated)
- 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.
Opioids provide greater patient comfort during intubation, but are not able to abolish completely the release adrenergic hormones during the laryngoscopy, which may cause undesirable hemodynamic changes.
In this study the investigators selected two techniques commonly used for intubation, laryngoscopy and track light, so the investigators can verify which intubation techniques provides less hemodynamic changes in coronary patients under standard anesthesia induction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laryngoscopy | Active comparator | Procedure: laryngoscopyLaryngoscopy Track Light teaqueal intubation |
| Track Light | Active comparator | Procedure: track light |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- coronary disease ASA 2 e 3 using beta-blockers
Key exclusion criteria (1 listed)
- emergency surgery arrythmia other antiarrythmic drugs
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 |
|---|---|---|
| laryngoscopyAlso: rigidy laryngoscopy,tracheal intubation with two different techniques, track light and laryngoscopy. | Procedure or surgery | Laryngoscopy |
| track light | Procedure or surgery | Track Light |
Primary outcome
hemodynamic response
Time frame: patient prepare (baseline), 1min after induction, 5 min after induction, 1 min after intubation
tracheal intubation with track light release less adrenergic hormones than laryngoscopy 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 11 Sep 2012.
- Background: PubMed 12208438Nishiyama T, Misawa K, Yokoyama T, Hanaoka K. Effects of combining midazolam and barbiturate on the response to tracheal intubation: changes in autonomic nervous system. J Clin Anesth. 2002 Aug;14(5):344-8. doi: 10.1016/s0952-8180(02)00370-7.
- Results publication: PubMed 19466360Nora FS, Klipel R, Ayala G, Oliveira Filho GR. [Remifentanil: does the infusion regimen make a difference in the prevention of hemodynamic responses to tracheal intubation?]. Rev Bras Anestesiol. 2007 Jun;57(3):247-60. doi: 10.1590/s0034-70942007000300003. Portuguese.
- Results publication: PubMed 19471727Almeida MC, Martins RS, Martins AL. [Tracheal intubation conditions at 60 seconds in children, adults and elderly patients.]. Rev Bras Anestesiol. 2004 Apr;54(2):204-11. doi: 10.1590/s0034-70942004000200007. Portuguese.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
Marcello F Salgado filho, MD principal investigator
Federal University of Juiz de Fora
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing laryngoscopy and track light in people with Coronary Disease Undergoing CABG, run by Federal University of Juiz de Fora at 1 site in Brazil.
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 1 inclusion and 1 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 11 Sep 2012. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
hemodynamic response (time frame: patient prepare (baseline), 1min after induction, 5 min after induction, 1 min after intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01682707, which also lists 3 linked publications.
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 11 Sep 2012.