Intubation TimeNCT05026671
The Effect of The Use of a Videolaryngoscope and/or Stylet on Intubation Time in Obese Patients
A study testing Endotracheal Tube Alone, Endotracheal Tube+ Stylet and Endotracheal Tube + Video-laryngoscope in people with Intubation Time, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Although many researchers would agree that obesity per se is not a risk factor for difficult intubation, there are many well known obesity-related challenges in airway management including difficulty with mask ventilation, more frequent and rapid oxygen desaturation, increased oxygen consumption, and increased… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation Time
- What is being tested?
- Endotracheal Tube Alone, Endotracheal Tube+ Stylet and Endotracheal Tube + Video-laryngoscope
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 30 Apr 2022
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with a documented body mass index (BMI) of ≥ 30.
- Patients scheduled to undergo inpatient surgery procedures under general anesthesia.
- Willingness and ability to sign an informed consent document 18 - 80 years of age
Who cannot join
- Patients who are deemed to be such a significant of an airway risk that they necessitate awake fiberoptic intubation
- Patients with a history of facial abnormalities, oral-pharyngeal cancer, or reconstructive surgery
- Emergency surgeries
- Pregnancy
- Any other conditions or use of any medication which may interfere with the conduct of the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karaman Training and Research Hospital
Karaman, 70200
About this study
Official title: The Effect of The Use of a Videolaryngoscope and/or Stylet on Intubation Time in Obese Patients: A Randomized Clinical Trial
Although many researchers would agree that obesity per se is not a risk factor for difficult intubation, there are many well known obesity-related challenges in airway management including difficulty with mask ventilation, more frequent and rapid oxygen desaturation, increased oxygen consumption, and increased sensitivity to the respiratory depressant effects of anesthetic and analgesic drugs. Hence, in these conditions, rapid and nontraumatic intubation gain higher interest. There is controversy about using videoaryngoscopy (VL) in obese patients in these difficult situations. The primary aim of this study is to compare, in terms of intubation time, VL,VL plus stylet and direct-laryngoscopy(DL) plus stylet combination with DL alone in obese patients.
Read the detailed description
Patients who will be scheduled for surgeries requiring endotracheal intubation, with a body mass index (BMI) more than 30 kg/m2, will be included to this study. During preanesthetic visit (performed by an anesthesiologist not involved in this study) history of difficult intubation, measurement of common predictive indices for difficult intubation (BMI, thyromental distance, neck circumference, Mallampati grade, interincisal [or intergingival] distances), and evaluation of status of dentition and neck movement will be noted.
In the operating room, all patients will be connected to standard monitoring devices. Anesthesia induction will be carried out according to our hospital obese patient anesthesia management protocol. Then, after induction of anesthesia, the patients will be intubated one of four pre-defined protocols that will be determined via randomization during a preanesthetic visit by a person who is unfamiliar with the research protocol.
Primary hypothesis of this study is; using a video-laryngoscope plus stylet will reduce the time required to achieve successful tracheal intubation in obese patients.
- Conditions
- Intubation Time
- Being tested
- Endotracheal Tube Alone, Endotracheal Tube+ Stylet, Endotracheal Tube + Video-laryngoscope, Endotracheal tube + stylet with Video-laryngoscope
- Keywords
- Obese Patients, Stylet Procedures, Video Laryngoscope, First-attempt intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal Tube AloneProcedure or surgery
Intubating the trachea with an endotracheal tube alone ( without stylet).
Endotracheal Tube+ StyletProcedure or surgery
Intubating the trachea with an endotracheal tube + stylet.
Endotracheal Tube + Video-laryngoscopeProcedure or surgery
Intubating the trachea with an endotracheal tube + Video- laryngoscope
Endotracheal tube + stylet with Video-laryngoscopeProcedure or surgery
Intubating the trachea with an endotracheal tube + stylet + Video-laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Group DL | Active comparator | The control group consists of intubating the trachea with an endotracheal tube alone (without stylet). Receives: Procedure: Endotracheal Tube Alone |
| Group DLS | Experimental | The Experimental group consists of intubating the trachea with an endotracheal tube + stylet. Receives: Procedure: Endotracheal Tube+ Stylet |
| Group VL | Experimental | The Experimental consists of intubating the trachea with an endotracheal tube + Video-laryngoscope Receives: Procedure: Endotracheal Tube + Video-laryngoscope |
| Group VLS | Experimental | The Experimental consists of intubating the trachea with an endotracheal tube + stylet + Video-laryngoscope Receives: Procedure: Endotracheal tube + stylet with Video-laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation Time Using a Stop Watch
The timing measurements will begin once the laryngoscope blade will be placed in the patient's mouth and ended when an end-tidal CO2 tracing will be detected.
Measured: Up to 3 minutes
Secondary outcomes (9)
Heart Rate
Before induction, after induction, after intubation, after intubation at 1st minute, 2nd minute, and 3rd minute
Measured: Before induction to 3 min after intubation
Mean Arterial Pressure:
Before induction, after induction, after intubation, after intubation at 1st minute, 2nd minute, and 3rd minute
Measured: Before induction to 3 min after intubation
Saturation
Before induction, after induction, after intubation, after intubation at 1st minute, 2nd minute, and 3rd minute
Measured: Before induction to 3 min after intubation
Incidence of severe complications following intubation
Hypoxia, collapse, cardiac arrest, death.
Measured: During intubation to 3 min after intubation
Glottis View Using the Cormack Lehane Score
Cormack Lehane score classification
Grade 1: Most of the glottis is visible Grade 2: At best almost half of the glottis is seen, at worst only the posterior tip of the arytenoids is seen Grade 3: Only the epiglottis is visible Grade 4: No laryngeal structures are visible
Measured: Up to 1 minute
Glottis View Using the POGO Score
the POGO score evaluate the glottic view during tracheal intubation using a classification of 1/2/3/4 and a score of 0% to 100%, respectively. The POGO score denote visualization of the entire glottic opening from the anterior commissure to the posterior cartilages, and a score of 0% denotes inability to visualize any part of the glottic opening.
Measured: Up to 1 minute
Number of intubation attempts
An intubation attempt will be defined as the insertion of the laryngoscope blade into the mouth of the patient, regardless of whether an attempt will be made to insert a tracheal tube. More than 5 attempts or 120 s will be regarded as a failure of intubation.
Measured: Up to postinduction 120 second
Ease of Intubation
Subjective evaluation of the anesthesiologist, rated as (1) very easy, (2) easy, (3) moderate, (4) difficult, and (5) impossible.
Measured: Up to 1 minute
Complications related to intubation
A postoperative follow-up assessment will be performed approximately 4 hr after surgery by a co-investigator blinded to the intubation device to evaluate the presence and severity of sore throat, any changes in voice, trauma to the lip, tongue, gum, or teeth.
Measured: postoperative 4th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start1 Sep 2021
- Primary completion18 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation TimeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karaman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Betul Basaran, MD, DESA, Study director, Karaman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026671
- Sponsor's protocol ID
- 05-2021/04
- Status last verified
- Aug 2021
- First submitted
- 22 Aug 2021
- Last updated
- 25 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of The Use of a Videolaryngoscope and/or Stylet on Intubation Time in Obese Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05026671
- Acronym / sponsor ID
- 05-2021/04
- Conditions
- Intubation Time
- Keywords
- Obese Patients, Stylet Procedures, Video Laryngoscope, First-attempt intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Karaman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 18 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 30 Aug 2021 (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.
Although many researchers would agree that obesity per se is not a risk factor for difficult intubation, there are many well known obesity-related challenges in airway management including difficulty with mask ventilation, more frequent and rapid oxygen desaturation, increased oxygen consumption, and increased sensitivity to the respiratory depressant effects of anesthetic and analgesic drugs. Hence, in these conditions, rapid and nontraumatic intubation gain higher interest. There is controversy about using videoaryngoscopy (VL) in obese patients in these difficult situations. The primary aim of this study is to compare, in terms of intubation time, VL,VL plus stylet and direct-laryngoscopy(DL) plus stylet combination with DL alone in obese patients.
Detailed description
Patients who will be scheduled for surgeries requiring endotracheal intubation, with a body mass index (BMI) more than 30 kg/m2, will be included to this study. During preanesthetic visit (performed by an anesthesiologist not involved in this study) history of difficult intubation, measurement of common predictive indices for difficult intubation (BMI, thyromental distance, neck circumference, Mallampati grade, interincisal [or intergingival] distances), and evaluation of status of dentition and neck movement will be noted.
In the operating room, all patients will be connected to standard monitoring devices. Anesthesia induction will be carried out according to our hospital obese patient anesthesia management protocol. Then, after induction of anesthesia, the patients will be intubated one of four pre-defined protocols that will be determined via randomization during a preanesthetic visit by a person who is unfamiliar with the research protocol.
Primary hypothesis of this study is; using a video-laryngoscope plus stylet will reduce the time required to achieve successful tracheal intubation in obese patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group DL | Active comparator | Procedure: Endotracheal Tube AloneThe control group consists of intubating the trachea with an endotracheal tube alone (without stylet). |
| Group DLS | Experimental | Procedure: Endotracheal Tube+ StyletThe Experimental group consists of intubating the trachea with an endotracheal tube + stylet. |
| Group VL | Experimental | Procedure: Endotracheal Tube + Video-laryngoscopeThe Experimental consists of intubating the trachea with an endotracheal tube + Video-laryngoscope |
| Group VLS | Experimental | Procedure: Endotracheal tube + stylet with Video-laryngoscopeThe Experimental consists of intubating the trachea with an endotracheal tube + stylet + Video-laryngoscope |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a documented body mass index (BMI) of ≥ 30.
- Patients scheduled to undergo inpatient surgery procedures under general anesthesia.
- Willingness and ability to sign an informed consent document 18 - 80 years of age
Key exclusion criteria (5 listed)
- Patients who are deemed to be such a significant of an airway risk that they necessitate awake fiberoptic intubation
- Patients with a history of facial abnormalities, oral-pharyngeal cancer, or reconstructive surgery
- Emergency surgeries
- Pregnancy
- Any other conditions or use of any medication which may interfere with the conduct of the study.
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 Tube AloneIntubating the trachea with an endotracheal tube alone ( without stylet). | Procedure or surgery | Group DL |
| Endotracheal Tube+ StyletIntubating the trachea with an endotracheal tube + stylet. | Procedure or surgery | Group DLS |
| Endotracheal Tube + Video-laryngoscopeIntubating the trachea with an endotracheal tube + Video- laryngoscope | Procedure or surgery | Group VL |
| Endotracheal tube + stylet with Video-laryngoscopeIntubating the trachea with an endotracheal tube + stylet + Video-laryngoscope | Procedure or surgery | Group VLS |
Primary outcome
Intubation Time Using a Stop Watch
Time frame: Up to 3 minutes
The timing measurements will begin once the laryngoscope blade will be placed in the patient's mouth and ended when an end-tidal CO2 tracing will be detected.
9 secondary outcomes
Heart Rate
Time frame: Before induction to 3 min after intubation
Mean Arterial Pressure:
Time frame: Before induction to 3 min after intubation
Saturation
Time frame: Before induction to 3 min after intubation
Incidence of severe complications following intubation
Time frame: During intubation to 3 min after intubation
Glottis View Using the Cormack Lehane Score
Time frame: Up to 1 minute
Glottis View Using the POGO Score
Time frame: Up to 1 minute
Number of intubation attempts
Time frame: Up to postinduction 120 second
Ease of Intubation
Time frame: Up to 1 minute
Complications related to intubation
Time frame: postoperative 4th hour
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 25 Nov 2022.
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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.
Betul Basaran, MD, DESA study director
Karaman 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 Endotracheal Tube Alone, Endotracheal Tube+ Stylet and Endotracheal Tube + Video-laryngoscope in people with Intubation Time, run by Karaman 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 3 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 25 Nov 2022. 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?
Intubation Time Using a Stop Watch (time frame: Up to 3 minutes). 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 25 Nov 2022.