Intubation;DifficultNCT03483285
Comparison of Two Different Videolaryngoscopes Regarding Hemodynamic Parameters in Open Heart Surgey
A study testing airtraq and storz in people with Intubation;Difficult and Coronary Bypass, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Endotracheal intubation increased the heart rate and blood pressure in normal patients. Open heart surgery patients are more prone to hemodynamic variability. In addition, they have increased possibility for difficult intubation The heart rate and blood pressure increase impaired the oxygen consumption. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Intubation;Difficult, Coronary Bypass
- What is being tested?
- airtraq and storz
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2018to 21 Mar 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing open heart surgery
- < 18 years of age
Who cannot join
- emergency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Videolaryngoscopes in Open Heart Surgery
Endotracheal intubation increased the heart rate and blood pressure in normal patients. Open heart surgery patients are more prone to hemodynamic variability. In addition, they have increased possibility for difficult intubation The heart rate and blood pressure increase impaired the oxygen consumption. This was previously shown that Videolaryngoscopes minimaly effects the vital signs in normal patients. Videolaryngoscopy inreased the rate of success in normal and difficult airway. This study aimed to compare two laryngoscopes regarding hemodynamic parameters and intubation times in coronary bypass surgery.
Read the detailed description
Aim: Endotracheal intubation increased the heart rate and blood pressure in normal patients. Open heart surgery patients are more prone to hemodynamic variability. In addition, they have increased possibility for difficult intubation The heart rate and blood pressure increase impaired the oxygen consumption. This was previously shown that Videolaryngoscopes minimaly effects the vital signs in normal patients. Videolaryngoscopy inreased the rate of success in normal and difficult airway. This study aimed to compare two laryngoscopes regarding hemodynamic parameters and intubation times in coronary bypass surgery.
Material and methods: 50 patients undergoing coronary bypass surgery enrolled in this prospective.randomized study. Demogaphic variables and airway characteristics of patients were recorded. Glottic visulisation and intubation time were recorded. Systolic blood pressure, diastolic blood pressure, mean arterial pressure and heart rate were recorded 2 minutes intervals before intubation, after intubation during 10 minutes.
- Conditions
- Intubation;Difficult, Coronary Bypass
- Being tested
- airtraq, storz
- Keywords
- intubation, airtraq, open heart surgery, hemodynamic parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
airtraqDevice
airtraq videolaryngoscope
storzDevice
storz videolaryngoscope
| Study group | Role | What they receive |
|---|---|---|
| heart rate | Active comparator | Effects of İntubation with Airtraq or Storz to heart rate Receives: Device: airtraq; Device: storz |
| mean arterial pressure | Active comparator | Effect of intubation with Airtraq or Storz to mean arterial pressure Receives: Device: airtraq; Device: storz |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate
heart rate
Measured: 2 months
Secondary outcomes (3)
insertion time
optimal glottic visualisation time
Measured: 2 months
intubation time
intubation time
Measured: 2 months
mean arterial pressure
mean arterial pressure
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start1 Apr 2018
- Primary completion20 Mar 2019
- Study completion21 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation;DifficultStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tülay Çardaközü, Kocaeli University
- Investigators
- Tulay Cardakozu, Principal investigator, Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483285
- Sponsor's protocol ID
- KOU-KAEK 2017-405
- Status last verified
- Feb 2021
- First submitted
- 15 Mar 2018
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Videolaryngoscopes in Open Heart Surgery
- ClinicalTrials.gov ID
- NCT03483285
- Acronym / sponsor ID
- KOU-KAEK 2017-405
- Conditions
- Intubation;Difficult, Coronary Bypass
- Keywords
- intubation, airtraq, open heart surgery, hemodynamic parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 20 Mar 2019 (actual)
- Study completion
- 21 Mar 2019 (actual)
- First posted
- 30 Mar 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.
Endotracheal intubation increased the heart rate and blood pressure in normal patients. Open heart surgery patients are more prone to hemodynamic variability. In addition, they have increased possibility for difficult intubation The heart rate and blood pressure increase impaired the oxygen consumption. This was previously shown that Videolaryngoscopes minimaly effects the vital signs in normal patients. Videolaryngoscopy inreased the rate of success in normal and difficult airway. This study aimed to compare two laryngoscopes regarding hemodynamic parameters and intubation times in coronary bypass surgery.
Detailed description
Aim: Endotracheal intubation increased the heart rate and blood pressure in normal patients. Open heart surgery patients are more prone to hemodynamic variability. In addition, they have increased possibility for difficult intubation The heart rate and blood pressure increase impaired the oxygen consumption. This was previously shown that Videolaryngoscopes minimaly effects the vital signs in normal patients. Videolaryngoscopy inreased the rate of success in normal and difficult airway. This study aimed to compare two laryngoscopes regarding hemodynamic parameters and intubation times in coronary bypass surgery.
Material and methods: 50 patients undergoing coronary bypass surgery enrolled in this prospective.randomized study. Demogaphic variables and airway characteristics of patients were recorded. Glottic visulisation and intubation time were recorded. Systolic blood pressure, diastolic blood pressure, mean arterial pressure and heart rate were recorded 2 minutes intervals before intubation, after intubation during 10 minutes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| heart rate | Active comparator | Device: airtraq, Device: storzEffects of İntubation with Airtraq or Storz to heart rate |
| mean arterial pressure | Active comparator | Device: airtraq, Device: storzEffect of intubation with Airtraq or Storz to mean arterial pressure |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients undergoing open heart surgery
- < 18 years of age
Key exclusion criteria (1 listed)
- emergency
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 videolaryngoscope | Device | heart rate, mean arterial pressure |
| storzstorz videolaryngoscope | Device | heart rate, mean arterial pressure |
Primary outcome
heart rate
Time frame: 2 months
heart rate
3 secondary outcomes
insertion time
Time frame: 2 months
intubation time
Time frame: 2 months
mean arterial pressure
Time frame: 2 months
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 17 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
Tulay Cardakozu principal investigator
Anesthesiology and Reanimation
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 storz in people with Intubation;Difficult and Coronary Bypass, run by Kocaeli University at 1 site in Turkey (Türkiye).
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 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 17 Feb 2021. 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 Turkey (Türkiye). 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?
heart rate (time frame: 2 months). 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 17 Feb 2021.