Oral IntubationNCT01091948
GlideScope Video Laryngoscope Versus Fiberoptic Intubation
A study testing Intubation with Fiberoptic laryngoscope and GlideScope® Video Laryngoscope in people with Oral Intubation, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Following informed consent, patients will be randomly assigned to oral fiberoptic intubation or to oral intubation using the GlideScope Video Laryngoscope. Following the induction of general anesthesia a sealed envelope would be opened to reveal the technique to be used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Intubation
- What is being tested?
- Intubation with Fiberoptic laryngoscope and GlideScope® Video Laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jan 2010
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years old
- scheduled for elective surgery requiring orotracheal intubation.
Who cannot join
- known, difficult airway
- loose teeth
- pregnant
- require a rapid sequence induction,
- Body Mass Index under 30
- unable to give consent
- if special endotracheal tube (ETT) is needed for the case.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GlideScope Video Laryngoscope vs Fiberoptic Intubation
Following informed consent, patients will be randomly assigned to oral fiberoptic intubation or to oral intubation using the GlideScope Video Laryngoscope. Following the induction of general anesthesia a sealed envelope would be opened to reveal the technique to be used. A stop watch will be started at the beginning of the procedure. At the completion of intubation the stop watch will be stopped and the time recorded along with other data. Based on a sample size estimation process, it is the investigators plan to study fifty patients. The two techniques will be compared in terms of the average time needed to place the endotracheal tube and studied using a two-sided T-Test with a significance level of 0.05. To ensure comparability between the two methods, all intubators will be required to have at experienced at least 10 uses of the GlideScope and 10 uses with fiberoptic intubation.
- Conditions
- Oral Intubation
- Being tested
- Intubation with Fiberoptic laryngoscope, GlideScope® Video Laryngoscope
- Keywords
- elective general surgery, orotracheal intubation, Patients would be eligible for inclusion if they were at least 18 years old and scheduled for elective surgery requiring orotracheal intubation.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intubation with Fiberoptic laryngoscopeDevice
Also called Fiberoptic, laryngoscope
Subjects will be intubated with the Fiberoptic laryngoscope.
GlideScope® Video LaryngoscopeDevice
Also called GlideScope®, Video Laryngoscope
Patients will be intubated with the GlideScope® Video Laryngoscope.
| Study group | Role | What they receive |
|---|---|---|
| Fiberoptic Intubation | Active comparator | Subjects will be intubated with the Fiberoptic laryngoscope. Receives: Device: Intubation with Fiberoptic laryngoscope |
| GlideScope® Video Laryngoscope | Active comparator | Subjects will be intubated with the GlideScope® Video Laryngoscope. Receives: Device: GlideScope® Video Laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Intubation (TTI) as Measured in Seconds
Time from insertion of either the GlideScope or in the case of fibreoptic intubation, a Williams airway (SunMed, Largo, FL, USA) into the mouth, to the time when end-tidal PCO2 exceeded 2.7 kPa (20 mmHg).
Measured: from start of intubation to successfully intubated up to 100 seconds
Secondary outcomes (6)
Intubation Difficulty Score
Intubation difficulty score is a 100-mm-long visual analogue scale (100 mm = extremely difficult);
Measured: from start of intubation to successfully intubated
Successful Intubation on 1st Attempt
Measured: from start of first intubation to end of first intubation attempt
Occurrence of Hypoxaemia
Arterial oxygen saturation was recorded at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after; hypoxaemia was defined as occurrence of arterial oxygen saturation <90% at any of the above measurements.
Measured: at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after
Trace Bleeding
Trace bleeding is a binary outcome: yes or no, which is determined based on amount of post-intubation bleeding present in the suction tube
Measured: Right after intubation
Sore Throat Grade
Measured: On the first postoperative day
Number of Intubation Attempts
Measured: from start of intubation to successfully intubated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startFeb 2008
- Primary completionJun 2009
- Study completionJan 2010
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 Oral IntubationStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel I Sessler, MD, Study chair, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091948
- Sponsor's protocol ID
- 08-079
- Status last verified
- Oct 2016
- First submitted
- 9 Mar 2010
- Last updated
- 20 Dec 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 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GlideScope Video Laryngoscope vs Fiberoptic Intubation
- ClinicalTrials.gov ID
- NCT01091948
- Acronym / sponsor ID
- 08-079
- Conditions
- Oral Intubation
- Keywords
- elective general surgery, orotracheal intubation, Patients would be eligible for inclusion if they were at least 18 years old and scheduled for elective surgery requiring orotracheal intubation.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 24 Mar 2010 (estimated)
- Results
- Posted 20 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Following informed consent, patients will be randomly assigned to oral fiberoptic intubation or to oral intubation using the GlideScope Video Laryngoscope. Following the induction of general anesthesia a sealed envelope would be opened to reveal the technique to be used. A stop watch will be started at the beginning of the procedure. At the completion of intubation the stop watch will be stopped and the time recorded along with other data. Based on a sample size estimation process, it is the investigators plan to study fifty patients. The two techniques will be compared in terms of the average time needed to place the endotracheal tube and studied using a two-sided T-Test with a significance level of 0.05. To ensure comparability between the two methods, all intubators will be required to have at experienced at least 10 uses of the GlideScope and 10 uses with fiberoptic intubation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fiberoptic Intubation | Active comparator | Device: Intubation with Fiberoptic laryngoscopeSubjects will be intubated with the Fiberoptic laryngoscope. |
| GlideScope® Video Laryngoscope | Active comparator | Device: GlideScope® Video LaryngoscopeSubjects will be intubated with the GlideScope® Video Laryngoscope. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least 18 years old
- scheduled for elective surgery requiring orotracheal intubation.
Key exclusion criteria (7 listed)
- known, difficult airway
- loose teeth
- pregnant
- require a rapid sequence induction,
- Body Mass Index under 30
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 |
|---|---|---|
| Intubation with Fiberoptic laryngoscopeAlso: Fiberoptic, laryngoscopeSubjects will be intubated with the Fiberoptic laryngoscope. | Device | Fiberoptic Intubation |
| GlideScope® Video LaryngoscopeAlso: GlideScope®, Video LaryngoscopePatients will be intubated with the GlideScope® Video Laryngoscope. | Device | GlideScope® Video Laryngoscope |
Primary outcome
Time to Intubation (TTI) as Measured in Seconds
Time frame: from start of intubation to successfully intubated up to 100 seconds
Time from insertion of either the GlideScope or in the case of fibreoptic intubation, a Williams airway (SunMed, Largo, FL, USA) into the mouth, to the time when end-tidal PCO2 exceeded 2.7 kPa (20 mmHg).
6 secondary outcomes
Intubation Difficulty Score
Time frame: from start of intubation to successfully intubated
Successful Intubation on 1st Attempt
Time frame: from start of first intubation to end of first intubation attempt
Occurrence of Hypoxaemia
Time frame: at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after
Trace Bleeding
Time frame: Right after intubation
Sore Throat Grade
Time frame: On the first postoperative day
Number of Intubation Attempts
Time frame: from start of intubation to successfully intubated
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Intensive Care
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.
Daniel I Sessler, MD study chair
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intubation with Fiberoptic laryngoscope and GlideScope® Video Laryngoscope in people with Oral Intubation, run by The Cleveland Clinic 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 2 inclusion and 7 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 20 Dec 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2016). 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?
Time to Intubation (TTI) as Measured in Seconds (time frame: from start of intubation to successfully intubated up to 100 seconds). 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 20 Dec 2016.