AnesthesiaPhase 4NCT01271543
Comparing Hemodynamic Changes for Intubation With Shikani Intubating Stylet and Macintosh Laryngoscope
A Phase 4 study testing Endotracheal Intubation in people with Anesthesia, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
Because of its simplicity of function and reliability, direct laryngoscopy it is routinely used for endotracheal intubation during general anesthesia. However, direct laryngoscopy is fraught with concerns for cardiovascular stimulation during induction of general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Endotracheal Intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Mar 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 - 75 years, ASA I and II, normotensive, Mallampati class: I and II, thyromental distance > than 6.5 cm, interincisor distance > than 3 cm, BMI < 35 Kg/m2
Who cannot join
- Exclusion criteria: pregnant patients, known or expected difficult airway, gastroesophageal reflux, esophageal pathology, pulmonary pathology, cardiovascular pathology.
Trial locations and contacts
1 site in 1 country.
United States1 site
PennState Hershey Medical Center
Hershey, Pennsylvania, 17036
About this study
Because of its simplicity of function and reliability, direct laryngoscopy it is routinely used for endotracheal intubation during general anesthesia. However, direct laryngoscopy is fraught with concerns for cardiovascular stimulation during induction of general anesthesia. This can be attributed to the placement of the laryngoscope blade into the vallecula and then applying force in an upward direction to expose the glottic opening. The average force necessary for visualization of the glottic opening is approximately 5.4kg. This can lead to significant pressor responses and tachycardia though stimuli to supraglottic region.
An alternative airway management device is the Shikani optical stylet (SOS). It is an effective, safe and reusable intubation device that has been shown to be effective in cases of difficult intubation. It consists of a fiberoptic bundle within a J - shaped malleable stainless steel sheath. At the proximal end of the sheath is an eyepiece with an attachment to a light source. An adjustable "tube stop" firmly affixes the endotracheal tube to the stylet, and has a port to be able to deliver oxygen. (4) The operator inserts the tip of the stylet with the loaded endotracheal tube into the patient's oropharynx and under direct visualization through the eyepiece, is able to visualize the vocal cords. Because the end of the stylet is at the end of the endotracheal tube, it can be directly visualized to be entering trachea past the vocal cords.
The investigators hypothesize that endotracheal intubation performed by the aid of SOS by minimizing oropharyngolaryngeal stimulation will result in fewer hemodynamic changes in patients with normal airways as compared with the MacIntosh laryngoscope.
- Conditions
- Anesthesia
- Being tested
- Endotracheal Intubation
- Keywords
- Comparison of hemodynamic, endotracheal intubation, changes induced by, performed, the aid of the SOS, as compared to the Macintosh Laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal IntubationDevice
General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with Shikani optical stylet (SOS) (one size) or MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for male in both groups. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
| Study group | Role | What they receive |
|---|---|---|
| MacIntosh group | Active comparator | Not described Receives: Device: Endotracheal Intubation |
| Shikani optical stylet | Experimental | Not described Receives: Device: Endotracheal Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate and Blood Pressure Double Product
The double product was measured. The double product is calculated by multiplying the heart rate with the systolic blood pressure. It is also known as the rate pressure product and it is used to measure hemodynamic response.The double product is calculated from the values obtained preinduction, during intubation and after intubation.(5 minutes after intubation)The double products from each time point are averaged to get one mean double product value.
Measured: Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation.
Secondary outcomes (1)
Time to Complete Laryngoscopy and Successful Intubation
Measured: Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnesthesiaStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonia Vaida, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271543
- Sponsor's protocol ID
- IRB 35113
- Other IDs
- IRB protocol 35113
- Status last verified
- Mar 2016
- First submitted
- 5 Jan 2011
- Last updated
- 15 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Hemodynamic Changes for Intubation With Shikani Intubating Stylet and Macintosh Laryngoscope
- ClinicalTrials.gov ID
- NCT01271543
- Acronym / sponsor ID
- IRB 35113
- Conditions
- Anesthesia
- Keywords
- Comparison of hemodynamic, endotracheal intubation, changes induced by, performed, the aid of the SOS, as compared to the Macintosh Laryngoscope
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 6 Jan 2011 (estimated)
- Results
- Posted 30 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Because of its simplicity of function and reliability, direct laryngoscopy it is routinely used for endotracheal intubation during general anesthesia. However, direct laryngoscopy is fraught with concerns for cardiovascular stimulation during induction of general anesthesia. This can be attributed to the placement of the laryngoscope blade into the vallecula and then applying force in an upward direction to expose the glottic opening. The average force necessary for visualization of the glottic opening is approximately 5.4kg. This can lead to significant pressor responses and tachycardia though stimuli to supraglottic region.
An alternative airway management device is the Shikani optical stylet (SOS). It is an effective, safe and reusable intubation device that has been shown to be effective in cases of difficult intubation. It consists of a fiberoptic bundle within a J - shaped malleable stainless steel sheath. At the proximal end of the sheath is an eyepiece with an attachment to a light source. An adjustable "tube stop" firmly affixes the endotracheal tube to the stylet, and has a port to be able to deliver oxygen. (4) The operator inserts the tip of the stylet with the loaded endotracheal tube into the patient's oropharynx and under direct visualization through the eyepiece, is able to visualize the vocal cords. Because the end of the stylet is at the end of the endotracheal tube, it can be directly visualized to be entering trachea past the vocal cords.
The investigators hypothesize that endotracheal intubation performed by the aid of SOS by minimizing oropharyngolaryngeal stimulation will result in fewer hemodynamic changes in patients with normal airways as compared with the MacIntosh laryngoscope.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MacIntosh group | Active comparator | Device: Endotracheal Intubation |
| Shikani optical stylet | Experimental | Device: Endotracheal Intubation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 - 75 years, ASA I and II, normotensive, Mallampati class: I and II, thyromental distance > than 6.5 cm, interincisor distance > than 3 cm, BMI < 35 Kg/m2
Key exclusion criteria (1 listed)
- Exclusion criteria: pregnant patients, known or expected difficult airway, gastroesophageal reflux, esophageal pathology, pulmonary pathology, cardiovascular pathology.
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 |
|---|---|---|
| Endotracheal IntubationGeneral anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with Shikani optical stylet (SOS) (one size) or MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for male in both groups. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery. | Device | MacIntosh group, Shikani optical stylet |
Primary outcome
Heart Rate and Blood Pressure Double Product
Time frame: Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation.
The double product was measured. The double product is calculated by multiplying the heart rate with the systolic blood pressure. It is also known as the rate pressure product and it is used to measure hemodynamic response.The double product is calculated from the values obtained preinduction, during intubation and after intubation.(5 minutes after intubation)The double products from each time point are averaged to get one mean double product value.
1 secondary outcome
Time to Complete Laryngoscopy and Successful Intubation
Time frame: Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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?
A Phase 4 study testing Endotracheal Intubation in people with Anesthesia, run by Milton S. Hershey Medical Center at 1 site in United States.
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 15 Apr 2016. 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 United States. 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?
Yes. Results are posted in the registry (first posted 30 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 and Blood Pressure Double Product (time frame: Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation.). 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 15 Apr 2016; AzTrials last refreshed its copy on 30 Oct 2026.