Orotracheal IntubationNCT04858906
Neutral Position Facilitates Orotracheal Intubation With Videolaryngoscopes
A study testing McGrath laryngoscope and C-MAC D-blade laryngoscope in people with Orotracheal Intubation, run by Mackay Memorial Hospital.
Trial summary
With the advent and more widespread use of video-assisted laryngoscopy (VL), the incidence of difficult intubation has decreased. However, the optimal position for endotracheal intubation facilitated by VL is not yet determined. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Orotracheal Intubation
- What is being tested?
- McGrath laryngoscope and C-MAC D-blade laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2021to 31 Dec 2024
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age above 20 years
- Anesthesiologists I-II
- who required orotracheal intubation for elective surgery
Who cannot join
- nasotracheal intubation
- awake tracheal intubation
- emergency surgery
- required rapid-sequence intubation (RSI)
- those in pregnancy
- with possible difficult intubation(with oropharyngeal pathology, limited neck mobility, previous head and neck surgical history)
Show all 9Show fewer
- anticipated difficult intubation assessed by preoperative Airway Difficult Score (≥ 7)
- with allergy history of common anesthetics agents
- any underlying comorbidities which refrain them from receiving common anesthetic agents
About this study
Official title: Neutral Position Facilitates Orotracheal Intubation With Videolaryngoscopes: A Comparing Angulated (McGrath) and Hyperangulated (C-MAC With D-blade) Videolaryngoscopes
With the advent and more widespread use of video-assisted laryngoscopy (VL), the incidence of difficult intubation has decreased. However, the optimal position for endotracheal intubation facilitated by VL is not yet determined. The objective of this study is to evaluate the effects of different patient positioning (neutral position versus sniffing position) on the glottic view and intubation time during orotracheal intubation facilitated by two video-assisted laryngoscopes (McGrath laryngoscope and C-MAC D-blade laryngoscope). A total of 252 patients who required orotracheal intubation for elective surgery were included in the study. Primary outcomes include airway difficulty score(ADS), intubation difficulty scale (IDS), the percentage of glottic opening (POGO) and intubation time. By the indexes above and crossover analysis, the study aimed to prove the ideal position for VL.
Read the detailed description
Endotracheal tube general anesthesia (ETGA) is required for a variety of surgeries. Traditionally, the patient is placed in a sniffing position to facilitate endotracheal intubation with a direct laryngoscope. Increased attempts in intubation or intubation failed may be encountered during direct laryngoscope, leading to hypoxemia or neurological sequelae. Injure to the teeth, gingiva or lips is also sometimes unavoidable. With the advent and more widespread use of video-assisted laryngoscopy (VL), the incidence of difficult intubation has decreased.
However, the optimal position for endotracheal intubation facilitated by VL is not yet determined. A previous study suggested that better glottic view is achieved when placing the patient in a neutral position than the sniffing position during orotracheal intubation by fiberoptic bronchoscopy. The objective of this study is to evaluate the effects of different patient positioning (neutral position versus sniffing position) on the glottic view and intubation time during orotracheal intubation facilitated by two video-assisted laryngoscopes (McGrath laryngoscope and C-MAC D-blade laryngoscope).
A total of 252 American Society of Anesthesiologists I-II patients, in the age above 20 years, who required orotracheal intubation for elective surgery were included in the study. Patients received nasotracheal intubation, awake tracheal intubation, emergency surgery, required rapid-sequence intubation (RSI), those in pregnancy, with possible difficult intubation(with oropharyngeal pathology, limited neck mobility, previous head and neck surgical history), anticipated difficult intubation assessed by preoperative Airway Difficult Score(ADS)(≥ 7), with allergy history of common anesthetics agents or any underlying comorbidities which refrain them from receiving common anesthetic agents were excluded.
The types of VL and the orders of position were randomly allocated by computer and the study take place in the operation room. Primary outcomes include airway difficulty (evaluated by ADS), ease of intubation (evaluated by intubation difficulty scale [IDS], the percentage of glottic opening [POGO]) and intubation time. By the indexes above and crossover analysis, the study aimed to prove the ideal position for VL, improve the efficiency of intubation and decrease the rate of difficult intubation by VL in the future.
- Conditions
- Orotracheal Intubation
- Being tested
- McGrath laryngoscope, C-MAC D-blade laryngoscope
- Keywords
- orotracheal intubation, neutral position, sniffing position, video-assisted laryngoscopes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McGrath laryngoscopeDevice
The patients in this group will be evaluated and intubated with McGrath laryngoscope (angulated videolaryngoscope).
C-MAC D-blade laryngoscopeDevice
The patients in this group will be evaluated and intubated with C-MAC D-blade laryngoscope (hyperangulated videolaryngoscope).
| Study group | Role | What they receive |
|---|---|---|
| from neutral to sniffing position | Active comparator | The patients in this group will be assessed firstly in the neutral position then subsequently in the sniffing position. Receives: Device: McGrath laryngoscope; Device: C-MAC D-blade laryngoscope |
| from sniffing position to neutral position | Active comparator | The patients in this group will be assessed firstly in the sniffing position then subsequently in the neutral position. Receives: Device: McGrath laryngoscope; Device: C-MAC D-blade laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
airway difficult score (ADS)
Airway difficult score (ADS) represents the airway difficulty and it includes thyro-mental distance, Mallampati score, mouth opening, neck mobility and upper incisions. Each element will be scored from 1 to 3 points accordingly. The higher the scores are, the more difficult the airway could be. The minimum value and the maximum value of the airway difficult score (ADS) are 5 and 15 respectively. The definition of possible difficult airway is when the airway difficult score (ADS) score is more than 7 points.
Measured: Airway difficult score (ADS) is assessed before induction and it take about 3 minutes.
intubation difficulty scale (IDS)
Intubation difficulty scale (IDS) represents ease of intubation and it includes times of intubation attempts, numbers of operators, grade of Modified Cormack-Lehane classification, lifting force, laryngeal pressure and vocal cord mobility. Intubation attempts, operators and grade of Modified Cormack-Lehane classification more than one will be scored directly to the numbers accordingly. The other elements will be scored from 0 to 1 point. The higher the scores are, the more difficult the intubation could be. The minimum value of the IDS is 0 and there is no limit of the maximum value. The definition of difficult intubation is when the intubation difficulty scale (IDS) score is more than 6 points.
Measured: intubation difficulty scale (IDS) is assessed during intubation and the time it take depend on the difficulty of the case.
percentage of glottic opening (POGO)
Both the glottic views in first position and in second position are evaluated as percentage of glottic opening (POGO) score, ranging from 0 to 100%. The glottic views will be recorded as digital image and be evaluated by another anesthesiologist subsequently.
Measured: Percentage of glottic opening (POGO) is evaluated by another anesthesiologist up to 24 hours after intubation ,and it take about 1 minutes.
intubation time
Time from when the patient's mouth is opened to the time when intubation is completed and the EtCO2 is detected by the monitor will be recorded.
Measured: Intubation time is assessed during intubation and the time it take depend on the difficulty of the case.
Secondary outcomes (1)
complications
Complications include tissue injury (injury to the teeth, gingiva or lips), sore throat, hoarseness and desaturation (SpO2<95%), which are recorded as "happened" or "not happened".
Measured: Tissue injury, sore throat and hoarseness are evaluated in the postoperative period (the day after the surgery). Desaturation or not is assessed during the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study startMay 2021 (estimated)
- Primary completionApr 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: Due to financial issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Orotracheal IntubationStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chien-Chung,Huang, Mackay Memorial Hospital
- Investigators
- Chien-Chung Huang, Bachelor, Principal investigator, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858906
- Sponsor's protocol ID
- 20MMHIS438e
- Status last verified
- Aug 2021
- First submitted
- 16 Apr 2021
- Last updated
- 31 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Greenland KB, Edwards MJ, Hutton NJ, Challis VJ, Irwin MG, Sleigh JW. Changes in airway configuration with different head and neck positions using magnetic resonance imaging of normal airways: a new concept with possible clinical applications. Br J Anaesth. 2010 Nov;105(5):683-90. doi: 10.1093/bja/aeq239. Epub 2010 Sep 15.
PubMed 20846964Park S, Lee HG, Choi JI, Lee S, Jang EA, Bae HB, Rhee J, Yang HC, Jeong S. Comparison of vocal cord view between neutral and sniffing position during orotracheal intubation using fiberoptic bronchoscope: a prospective, randomized cross over study. BMC Anesthesiol. 2019 Jan 5;19(1):3. doi: 10.1186/s12871-018-0671-9.
PubMed 30611215Kang R, Jeong JS, Ko JS, Ahn J, Gwak MS, Choi SJ, Hwang JY, Hahm TS. Neutral Position Facilitates Nasotracheal Intubation with a GlideScope Video Laryngoscope: A Randomized Controlled Trial. J Clin Med. 2020 Mar 2;9(3):671. doi: 10.3390/jcm9030671.
PubMed 32131521
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutral Position Facilitates Orotracheal Intubation With Videolaryngoscopes: A Comparing Angulated (McGrath) and Hyperangulated (C-MAC With D-blade) Videolaryngoscopes
- ClinicalTrials.gov ID
- NCT04858906
- Acronym / sponsor ID
- 20MMHIS438e
- Conditions
- Orotracheal Intubation
- Keywords
- orotracheal intubation, neutral position, sniffing position, video-assisted laryngoscopes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to financial issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Apr 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.
With the advent and more widespread use of video-assisted laryngoscopy (VL), the incidence of difficult intubation has decreased. However, the optimal position for endotracheal intubation facilitated by VL is not yet determined. The objective of this study is to evaluate the effects of different patient positioning (neutral position versus sniffing position) on the glottic view and intubation time during orotracheal intubation facilitated by two video-assisted laryngoscopes (McGrath laryngoscope and C-MAC D-blade laryngoscope). A total of 252 patients who required orotracheal intubation for elective surgery were included in the study. Primary outcomes include airway difficulty score(ADS), intubation difficulty scale (IDS), the percentage of glottic opening (POGO) and intubation time. By the indexes above and crossover analysis, the study aimed to prove the ideal position for VL.
Detailed description
Endotracheal tube general anesthesia (ETGA) is required for a variety of surgeries. Traditionally, the patient is placed in a sniffing position to facilitate endotracheal intubation with a direct laryngoscope. Increased attempts in intubation or intubation failed may be encountered during direct laryngoscope, leading to hypoxemia or neurological sequelae. Injure to the teeth, gingiva or lips is also sometimes unavoidable. With the advent and more widespread use of video-assisted laryngoscopy (VL), the incidence of difficult intubation has decreased.
However, the optimal position for endotracheal intubation facilitated by VL is not yet determined. A previous study suggested that better glottic view is achieved when placing the patient in a neutral position than the sniffing position during orotracheal intubation by fiberoptic bronchoscopy. The objective of this study is to evaluate the effects of different patient positioning (neutral position versus sniffing position) on the glottic view and intubation time during orotracheal intubation facilitated by two video-assisted laryngoscopes (McGrath laryngoscope and C-MAC D-blade laryngoscope).
A total of 252 American Society of Anesthesiologists I-II patients, in the age above 20 years, who required orotracheal intubation for elective surgery were included in the study. Patients received nasotracheal intubation, awake tracheal intubation, emergency surgery, required rapid-sequence intubation (RSI), those in pregnancy, with possible difficult intubation(with oropharyngeal pathology, limited neck mobility, previous head and neck surgical history), anticipated difficult intubation assessed by preoperative Airway Difficult Score(ADS)(≥ 7), with allergy history of common anesthetics agents or any underlying comorbidities which refrain them from receiving common anesthetic agents were excluded.
The types of VL and the orders of position were randomly allocated by computer and the study take place in the operation room. Primary outcomes include airway difficulty (evaluated by ADS), ease of intubation (evaluated by intubation difficulty scale [IDS], the percentage of glottic opening [POGO]) and intubation time. By the indexes above and crossover analysis, the study aimed to prove the ideal position for VL, improve the efficiency of intubation and decrease the rate of difficult intubation by VL in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| from neutral to sniffing position | Active comparator | Device: McGrath laryngoscope, Device: C-MAC D-blade laryngoscopeThe patients in this group will be assessed firstly in the neutral position then subsequently in the sniffing position. |
| from sniffing position to neutral position | Active comparator | Device: McGrath laryngoscope, Device: C-MAC D-blade laryngoscopeThe patients in this group will be assessed firstly in the sniffing position then subsequently in the neutral position. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age above 20 years
- Anesthesiologists I-II
- who required orotracheal intubation for elective surgery
Key exclusion criteria (9 listed)
- nasotracheal intubation
- awake tracheal intubation
- emergency surgery
- required rapid-sequence intubation (RSI)
- those in pregnancy
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 |
|---|---|---|
| McGrath laryngoscopeThe patients in this group will be evaluated and intubated with McGrath laryngoscope (angulated videolaryngoscope). | Device | from neutral to sniffing position, from sniffing position to neutral position |
| C-MAC D-blade laryngoscopeThe patients in this group will be evaluated and intubated with C-MAC D-blade laryngoscope (hyperangulated videolaryngoscope). | Device | from neutral to sniffing position, from sniffing position to neutral position |
Primary outcome
airway difficult score (ADS)
Time frame: Airway difficult score (ADS) is assessed before induction and it take about 3 minutes.
Airway difficult score (ADS) represents the airway difficulty and it includes thyro-mental distance, Mallampati score, mouth opening, neck mobility and upper incisions. Each element will be scored from 1 to 3 points accordingly. The higher the scores are, the more difficult the airway could be. The minimum value and the maximum value of the airway difficult score (ADS) are 5 and 15 respectively. The definition of possible difficult airway is when the airway difficult score (ADS) score is more than 7 points.
intubation difficulty scale (IDS)
Time frame: intubation difficulty scale (IDS) is assessed during intubation and the time it take depend on the difficulty of the case.
Intubation difficulty scale (IDS) represents ease of intubation and it includes times of intubation attempts, numbers of operators, grade of Modified Cormack-Lehane classification, lifting force, laryngeal pressure and vocal cord mobility. Intubation attempts, operators and grade of Modified Cormack-Lehane classification more than one will be scored directly to the numbers accordingly. The other elements will be scored from 0 to 1 point. The higher the scores are, the more difficult the intubation could be. The minimum value of the IDS is 0 and there is no limit of the maximum value. The definition of difficult intubation is when the intubation difficulty scale (IDS) score is more than 6 points.
percentage of glottic opening (POGO)
Time frame: Percentage of glottic opening (POGO) is evaluated by another anesthesiologist up to 24 hours after intubation ,and it take about 1 minutes.
Both the glottic views in first position and in second position are evaluated as percentage of glottic opening (POGO) score, ranging from 0 to 100%. The glottic views will be recorded as digital image and be evaluated by another anesthesiologist subsequently.
intubation time
Time frame: Intubation time is assessed during intubation and the time it take depend on the difficulty of the case.
Time from when the patient's mouth is opened to the time when intubation is completed and the EtCO2 is detected by the monitor will be recorded.
1 secondary outcome
complications
Time frame: Tissue injury, sore throat and hoarseness are evaluated in the postoperative period (the day after the surgery). Desaturation or not is assessed during the procedure.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Background: PubMed 20846964Greenland KB, Edwards MJ, Hutton NJ, Challis VJ, Irwin MG, Sleigh JW. Changes in airway configuration with different head and neck positions using magnetic resonance imaging of normal airways: a new concept with possible clinical applications. Br J Anaesth. 2010 Nov;105(5):683-90. doi: 10.1093/bja/aeq239. Epub 2010 Sep 15.
- Background: PubMed 30611215Park S, Lee HG, Choi JI, Lee S, Jang EA, Bae HB, Rhee J, Yang HC, Jeong S. Comparison of vocal cord view between neutral and sniffing position during orotracheal intubation using fiberoptic bronchoscope: a prospective, randomized cross over study. BMC Anesthesiol. 2019 Jan 5;19(1):3. doi: 10.1186/s12871-018-0671-9.
- Background: PubMed 32131521Kang R, Jeong JS, Ko JS, Ahn J, Gwak MS, Choi SJ, Hwang JY, Hahm TS. Neutral Position Facilitates Nasotracheal Intubation with a GlideScope Video Laryngoscope: A Randomized Controlled Trial. J Clin Med. 2020 Mar 2;9(3):671. doi: 10.3390/jcm9030671.
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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.
Chien-Chung Huang, Bachelor principal investigator
Mackay Memorial Hospital
Questions about this trial
What is this clinical trial studying?
A study testing McGrath laryngoscope and C-MAC D-blade laryngoscope in people with Orotracheal Intubation, run by Mackay Memorial Hospital.
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 9 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: withdrawn, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
airway difficult score (ADS) (time frame: Airway difficult score (ADS) is assessed before induction and it take about 3 minutes.). The study lists 4 primary outcomes in all. 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 NCT04858906, which also lists 3 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 31 Aug 2021.