Anesthesia Intubation ComplicationNCT02564640
Comparison of Hemodynamic Changes by Using the Videolaryngoscope and the Macintosh Laryngoscope
A study testing videolaryngoscope and Macintosh laryngoscope in people with Anesthesia Intubation Complication, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Tracheal intubation techniques that avoid or minimize pharyngolaryngeal stimulation might attenuate the hemodynamic stress response. Tracheal intubation using video laryngoscope needs comparatively less airway manipulation so, the investigators expect less hemodynamic response while using videolaryngoscope. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Anesthesia Intubation Complication
- What is being tested?
- videolaryngoscope and Macintosh laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2015to Sep 2015
- 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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- American Society of Anesthesiologists Physical Status II-III,
- aged over 65 years,
- controlled hypertensive patients,
- scheduled for elective coronary artery bypass grafting.
Who cannot join
- American Society of Anesthesiologists Physical Status IV,
- ejection fraction < 40%,
- any anatomical abnormality in head, neck or face,
- Mallampati score of IV,
- history of difficult intubation or laryngoscopy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital
Antalya, 07070
About this study
Official title: Comparison of Hemodynamic Changes After Endotracheal Intubation by Using the Videolaryngoscope and the Macintosh Direct Laryngoscope in Elderly Hypertensive Patients
Tracheal intubation techniques that avoid or minimize pharyngolaryngeal stimulation might attenuate the hemodynamic stress response. Tracheal intubation using video laryngoscope needs comparatively less airway manipulation so, the investigators expect less hemodynamic response while using videolaryngoscope.
Read the detailed description
The hemodynamic stress response to tracheal intubation can precipitate adverse cardiovascular events in patients with cardiovascular disease. Which is shown to greatly increase the risk of myocardial infarction or stroke, especially in elderly patients with hypertension. Direct laryngoscopy and laryngoscopic stimulation of pharyngolaryngeal structures may be an important factor in the hemodynamic stress response associated with tracheal intubation.
Patients were randomly allocated to two groups using a permuted block randomization method: 1) patients intubated by using the videolaryngoscopy 2) patients intubated by using the Macintosh laryngoscope . SAP, MAP, and heart rate were measured and recorded in the operating room: At baseline, before intubation, immediately after intubation and 1,2,3,4 and 5 minutes after tracheal intubation.
- Conditions
- Anesthesia Intubation Complication
- Being tested
- videolaryngoscope, Macintosh laryngoscope
- Keywords
- videolaryngoscope, direct laryngoscope, hemodynamic changes, elderly patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
videolaryngoscopeDevice
patients intubated by using the videolaryngoscope
Macintosh laryngoscopeDevice
patients intubated by using the Macintosh laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| videolaryngoscope | Active comparator | patients intubated by using the videolaryngoscopy Receives: Device: videolaryngoscope |
| Macintosh laryngoscope | Active comparator | patients intubated by using the Macintosh laryngoscope Receives: Device: Macintosh laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure changes during tracheal intubation ( mmHg ) ,
Measured: At baseline, 1 minute before intubation, and 1,2,3,4 and 5 minutes after tracheal intubation
Secondary outcomes (3)
Heart rate changes during tracheal intubation (beats per minute)
Measured: At baseline, 1 minute before intubation, and 1,2,3,4 and 5 minutes after tracheal intubation
ST segment elevation in electrocardiogram indicating myocardial ischaemia during tracheal intubation
During tracheal intubation electrocardiogram is monitorized.
Measured: At baseline, 1 and 5 minutes after tracheal intubation.
Arrhythmic changes in electrocardiogram during tracheal intubation
During tracheal intubation electrocardiogram is monitorized.
Measured: At baseline, 1 and 5 minutes after tracheal intubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startJun 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anesthesia Intubation ComplicationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nilgun Kavrut Ozturk, MD, Study director, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564640
- Sponsor's protocol ID
- AntalyaTRH 008
- Status last verified
- Jun 2015
- First submitted
- 28 Sep 2015
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kihara S, Brimacombe J, Yaguchi Y, Watanabe S, Taguchi N, Komatsuzaki T. Hemodynamic responses among three tracheal intubation devices in normotensive and hypertensive patients. Anesth Analg. 2003 Mar;96(3):890-895. doi: 10.1213/01.ANE.0000048706.15720.C9.
PubMed 12598280Kanaide M, Fukusaki M, Tamura S, Takada M, Miyako M, Sumikawa K. Hemodynamic and catecholamine responses during tracheal intubation using a lightwand device (Trachlight) in elderly patients with hypertension. J Anesth. 2003;17(3):161-5. doi: 10.1007/s00540-003-0166-8.
PubMed 12911202Xue FS, Zhang GH, Li XY, Sun HT, Li P, Li CW, Liu KP. Comparison of hemodynamic responses to orotracheal intubation with the GlideScope videolaryngoscope and the Macintosh direct laryngoscope. J Clin Anesth. 2007 Jun;19(4):245-50. doi: 10.1016/j.jclinane.2006.11.004.
PubMed 17572317Xue FS, Zhang GH, Li XY, Sun HT, Li P, Sun HY, Xu YC, Liu Y. Comparison of haemodynamic responses to orotracheal intubation with GlideScope videolaryngoscope and fibreoptic bronchoscope. Eur J Anaesthesiol. 2006 Jun;23(6):522-6. doi: 10.1017/S0265021506000299. Epub 2006 Mar 1.
PubMed 16507195
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hemodynamic Changes After Endotracheal Intubation by Using the Videolaryngoscope and the Macintosh Direct Laryngoscope in Elderly Hypertensive Patients
- ClinicalTrials.gov ID
- NCT02564640
- Acronym / sponsor ID
- AntalyaTRH 008
- Conditions
- Anesthesia Intubation Complication
- Keywords
- videolaryngoscope, direct laryngoscope, hemodynamic changes, elderly patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- Jun 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 1 Oct 2015 (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.
Tracheal intubation techniques that avoid or minimize pharyngolaryngeal stimulation might attenuate the hemodynamic stress response. Tracheal intubation using video laryngoscope needs comparatively less airway manipulation so, the investigators expect less hemodynamic response while using videolaryngoscope.
Detailed description
The hemodynamic stress response to tracheal intubation can precipitate adverse cardiovascular events in patients with cardiovascular disease. Which is shown to greatly increase the risk of myocardial infarction or stroke, especially in elderly patients with hypertension. Direct laryngoscopy and laryngoscopic stimulation of pharyngolaryngeal structures may be an important factor in the hemodynamic stress response associated with tracheal intubation.
Patients were randomly allocated to two groups using a permuted block randomization method: 1) patients intubated by using the videolaryngoscopy 2) patients intubated by using the Macintosh laryngoscope . SAP, MAP, and heart rate were measured and recorded in the operating room: At baseline, before intubation, immediately after intubation and 1,2,3,4 and 5 minutes after tracheal intubation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| videolaryngoscope | Active comparator | Device: videolaryngoscopepatients intubated by using the videolaryngoscopy |
| Macintosh laryngoscope | Active comparator | Device: Macintosh laryngoscopepatients intubated by using the Macintosh laryngoscope |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists Physical Status II-III,
- aged over 65 years,
- controlled hypertensive patients,
- scheduled for elective coronary artery bypass grafting.
Key exclusion criteria (5 listed)
- American Society of Anesthesiologists Physical Status IV,
- ejection fraction < 40%,
- any anatomical abnormality in head, neck or face,
- Mallampati score of IV,
- history of difficult intubation or laryngoscopy
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 |
|---|---|---|
| videolaryngoscopepatients intubated by using the videolaryngoscope | Device | videolaryngoscope |
| Macintosh laryngoscopepatients intubated by using the Macintosh laryngoscope | Device | Macintosh laryngoscope |
Primary outcome
Blood pressure changes during tracheal intubation ( mmHg ) ,
Time frame: At baseline, 1 minute before intubation, and 1,2,3,4 and 5 minutes after tracheal intubation
3 secondary outcomes
Heart rate changes during tracheal intubation (beats per minute)
Time frame: At baseline, 1 minute before intubation, and 1,2,3,4 and 5 minutes after tracheal intubation
ST segment elevation in electrocardiogram indicating myocardial ischaemia during tracheal intubation
Time frame: At baseline, 1 and 5 minutes after tracheal intubation.
Arrhythmic changes in electrocardiogram during tracheal intubation
Time frame: At baseline, 1 and 5 minutes after tracheal 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 9 Dec 2015.
- Background: PubMed 12598280Kihara S, Brimacombe J, Yaguchi Y, Watanabe S, Taguchi N, Komatsuzaki T. Hemodynamic responses among three tracheal intubation devices in normotensive and hypertensive patients. Anesth Analg. 2003 Mar;96(3):890-895. doi: 10.1213/01.ANE.0000048706.15720.C9.
- Background: PubMed 12911202Kanaide M, Fukusaki M, Tamura S, Takada M, Miyako M, Sumikawa K. Hemodynamic and catecholamine responses during tracheal intubation using a lightwand device (Trachlight) in elderly patients with hypertension. J Anesth. 2003;17(3):161-5. doi: 10.1007/s00540-003-0166-8.
- Results publication: PubMed 17572317Xue FS, Zhang GH, Li XY, Sun HT, Li P, Li CW, Liu KP. Comparison of hemodynamic responses to orotracheal intubation with the GlideScope videolaryngoscope and the Macintosh direct laryngoscope. J Clin Anesth. 2007 Jun;19(4):245-50. doi: 10.1016/j.jclinane.2006.11.004.
- Results publication: PubMed 16507195Xue FS, Zhang GH, Li XY, Sun HT, Li P, Sun HY, Xu YC, Liu Y. Comparison of haemodynamic responses to orotracheal intubation with GlideScope videolaryngoscope and fibreoptic bronchoscope. Eur J Anaesthesiol. 2006 Jun;23(6):522-6. doi: 10.1017/S0265021506000299. Epub 2006 Mar 1.
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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.
Nilgun Kavrut Ozturk, MD study director
Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing videolaryngoscope and Macintosh laryngoscope in people with Anesthesia Intubation Complication, run by Antalya Training and Research Hospital 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 4 inclusion and 5 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 9 Dec 2015. 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?
Blood pressure changes during tracheal intubation ( mmHg ) , (time frame: At baseline, 1 minute before intubation, and 1,2,3,4 and 5 minutes after tracheal 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 NCT02564640, which also lists 4 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 9 Dec 2015.