Intubation ComplicationNCT03184246
The Depth of Endotracheal Tube Insertion
A study testing GlideScope and Direct laryngoscopy in people with Intubation Complication, run by University Hospital Hradec Kralove at 1 site in Czechia.
Trial summary
The investigators suppose that direct laryngoscopy is connected with deeper insertion of endotracheal tube in comparison to videolaryngoscopy. Correction of this malposition can cause postoperative discomfort and further complications in some patients.Routine use of videolaryngoscopy could minimize these problems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation Complication
- What is being tested?
- GlideScope and Direct laryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 30 Jun 2017to 4 Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical status I - III
Who cannot join
- postoperative ventilation, laryngeal tumors, conditions after tracheotomy or laryngeal operations, cervical spinal hernia extraction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Depth of Endotracheal Tube Insertion - Use of Direct Laryngoscopy and Videolaryngoscopy (GlideScope), Comparison of Methods
The investigators suppose that direct laryngoscopy is connected with deeper insertion of endotracheal tube in comparison to videolaryngoscopy. Correction of this malposition can cause postoperative discomfort and further complications in some patients.Routine use of videolaryngoscopy could minimize these problems.
Read the detailed description
100 patients scheduled for elective neurosurgical procedures will be randomized into two groups. Patients in group A will be intubated by videolaryngoscopy (GlideScope), patients in group B by direct laryngoscopy, in both groups will be rigid stylet used. Intubation will be done under propofol anesthesia, targeted entropy 40 to 50, and deep relaxation (neuromuscular transmission target level 0). Sufentanil will be used to block tracheal reflexes. In both groups the depth of insertion of tracheal tube will be measured in the mouth corner immediately after intubation. Next day, the unpleasant sensations and complications will be recorded (sore throat, stridor, hoarseness, cough and nausea and vomiting) during control visit of patients.
- Conditions
- Intubation Complication
- Being tested
- GlideScope, Direct laryngoscopy
- Keywords
- Videolaryngoscopy (GlideScope), Direct laryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlideScopeDevice
videolaryngoscopy (GlideScope) will be used for intubation
Direct laryngoscopyDevice
direct laryngoscopy will be used for intubation
| Study group | Role | What they receive |
|---|---|---|
| GlideScope | Experimental | intubation with GlideScope Receives: Device: GlideScope |
| Direct laryngoscopy | Active comparator | intubation with laryngoscope Receives: Device: Direct laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the depth of primary insertion of tracheal tube
cm
Measured: in a minute after intubation
Secondary outcomes (2)
sums of manipulation with tracheal tube
number
Measured: 2 minutes after intubation
complications after intubation
number
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start30 Jun 2017
- Primary completion1 Dec 2018
- Study completion4 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- Interventional group will be intubated by videolaryngoscopy, control group by direct laryngoscopy
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove
- Investigators
- Pavel Dostal, MD, Ph.D., Study director, University Hospital Hradec Kralove
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184246
- Sponsor's protocol ID
- University Hospital
- Status last verified
- Dec 2018
- First submitted
- 8 Jun 2017
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Depth of Endotracheal Tube Insertion - Use of Direct Laryngoscopy and Videolaryngoscopy (GlideScope), Comparison of Methods
- ClinicalTrials.gov ID
- NCT03184246
- Acronym / sponsor ID
- University Hospital
- Conditions
- Intubation Complication
- Keywords
- Videolaryngoscopy (GlideScope), Direct laryngoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 4 Dec 2018 (actual)
- First posted
- 12 Jun 2017 (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.
The investigators suppose that direct laryngoscopy is connected with deeper insertion of endotracheal tube in comparison to videolaryngoscopy. Correction of this malposition can cause postoperative discomfort and further complications in some patients.Routine use of videolaryngoscopy could minimize these problems.
Detailed description
100 patients scheduled for elective neurosurgical procedures will be randomized into two groups. Patients in group A will be intubated by videolaryngoscopy (GlideScope), patients in group B by direct laryngoscopy, in both groups will be rigid stylet used. Intubation will be done under propofol anesthesia, targeted entropy 40 to 50, and deep relaxation (neuromuscular transmission target level 0). Sufentanil will be used to block tracheal reflexes. In both groups the depth of insertion of tracheal tube will be measured in the mouth corner immediately after intubation. Next day, the unpleasant sensations and complications will be recorded (sore throat, stridor, hoarseness, cough and nausea and vomiting) during control visit of patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional group will be intubated by videolaryngoscopy, control group by direct laryngoscopy
| Arm | Type | Receives |
|---|---|---|
| GlideScope | Experimental | Device: GlideScopeintubation with GlideScope |
| Direct laryngoscopy | Active comparator | Device: Direct laryngoscopyintubation with laryngoscope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists physical status I - III
Key exclusion criteria (1 listed)
- postoperative ventilation, laryngeal tumors, conditions after tracheotomy or laryngeal operations, cervical spinal hernia extraction
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 |
|---|---|---|
| GlideScopevideolaryngoscopy (GlideScope) will be used for intubation | Device | GlideScope |
| Direct laryngoscopydirect laryngoscopy will be used for intubation | Device | Direct laryngoscopy |
Primary outcome
the depth of primary insertion of tracheal tube
Time frame: in a minute after intubation
cm
2 secondary outcomes
sums of manipulation with tracheal tube
Time frame: 2 minutes after intubation
complications after intubation
Time frame: 24 hours after surgery
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 6 Dec 2018.
- Individual participant dataSharing planned: No
Related trials for Intubation Complication
Recruiting
Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study
Intubation Complication
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The ED-AWARENESS-2 Trial
Awareness, Mechanical Ventilation
RecruitingObservational study
Cardiovascular History and Hemodynamic Complications After Intubation in ICU
Hemodynamic Complications
Not yet recruiting
Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
Postoperative Pulmonary Complications
Not yet recruiting
Establish Whether Hyperangulated Videolaryngoscopy (HAVL) Can be Used to Facilitate Tracheal Intubation Effectively and Safely in Unselected Adult Patients; Describe the Population in Whom HAVL Fails to Facilitate Tracheal Intubation Successfully, Identifying Any Contributory Characteristics.
Intubation Skill, Intubation Complications
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.
Pavel Dostal, MD, Ph.D. study director
University Hospital Hradec Kralove
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GlideScope and Direct laryngoscopy in people with Intubation Complication, run by University Hospital Hradec Kralove at 1 site in Czechia.
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 6 Dec 2018. 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 Czechia. 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?
the depth of primary insertion of tracheal tube (time frame: in a minute after 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 6 Dec 2018.