Airway Complication of AnesthesiaNCT03810937
Optimal Head and Neck Position for Videolaryngoscopy
A study testing head position in people with Airway Complication of Anesthesia, run by King Fahad Specialist Hospital Dammam at 1 site in Saudi Arabia.
Trial summary
The introduction of videolaryngoscopy constituted a revolution in airway management since it could provide better laryngeal exposure (indirect) in situations of difficult or impossible visualization by direct laryngoscopy. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Airway Complication of Anesthesia
- What is being tested?
- head position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Aug 2018to 1 Mar 2019
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients with American Society of Anesthesiologists physical status 1-3 who are scheduled for elective surgery requiring endotracheal intubation.
Who cannot join
- history of difficult intubation, poor dentition, gastroesophageal reflux disease ,initial low oxygen saturation, severe/morbid obesity (body mass index [BMI] greater than 35 kg/m2),neck deformities, atlano-axial subluxation or at risk of aspiration.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Fahad Specialist Hospital
Dammam, Eastern Province, 31444
AHED M ZAIDANE, MD, +966138442222 ext. 3993, AHED.ZEIDAN@KFSH.MED.SA
About this study
Official title: Optimal Head and Neck Position for Videolaryngoscopy Intubation
The introduction of videolaryngoscopy constituted a revolution in airway management since it could provide better laryngeal exposure (indirect) in situations of difficult or impossible visualization by direct laryngoscopy. The use of Videolaryngoscopes, however, does not always guarantee adequate exposure or end up always in successful tracheal intubation. Failed tracheal intubation with videolaryngoscopy has been reported. We hypothesized that may be the failure was due to omitting some preparatory steps, including optimal head positioning, leading to a less than expected exposure and/or difficult or impossible intubation. There are no recommendations currently from the scientific organizations regarding the optimal head position when using a GlideScope and it is unknown currently whether head position can affect visualization or tracheal intubation attempts when using this device.
Read the detailed description
- Multicentric,randomized, prospective and controlled study.
- After Institutional Review Board approval, signed written informed consents will be obtained from 165 adult patients with American Society of Anesthesiologists physical status 1-3 who are scheduled for elective surgery requiring endotracheal intubation.
- The following parameters will assessed and documented during the preoperative airway evaluation: BMI, mouth opening, thyromental distance, range of neck movement, and modified Mallampati classification. An 8cm non-compressible pillow.
- Patients will be randomized following coin toss into two groups depending on intubation position; Group Sniffing position(S) for obverse side and group flat position(F) for reverse side
- After premedication, American Society of Anesthesiologists' standard monitors will be applied, and preoxygenation for 3 to 5 minutes will be performed. After anesthesia induction and complete muscle relaxation as evidenced by loss of all evoked adductor pollicis responses to train of four stimulation of the ulnar nerve:
- Group sniffing (S): investigator will start by performing first videolaryngoscopy to find best view in flat position then the anesthesiologist will remove the Glidescope and the patient will be positioned in sniffing position using the pillow and another videolaryngoscopy will be attempted in sniffing position to find best view in this position and the patient will be intubated in this position.
- Group flat (F): same procedure will be done but starting from sniffing position and the patient will be intubated in flat position.
- The laryngoscopist will be asked not to use external laryngeal manipulation and to use the same lifting force throughout the study period. If these maneuvers deemed necessary for tracheal intubation (no visualization of vocal cords from full inflation to full deflation or the reverse, the laryngoscopist will be asked grade the view before applying the maneuver then use the required maneuver and record which intervention was needed and utilized.
- The estimated time to review theses different head elevation degrees is around 45 seconds.
- After preoxygenation technique we have a margin of 6 to 8 minutes of apnea without significant desaturation. Investigator will exclude also patients with high risk of desaturation (obesity and initial low saturation).
- The indirect laryngoscopic views will be graded using the same grading method used for direct laryngoscopy i.e. modified Cormack and Lehane. POGO score (percent of glottis opening viewed) will be also used to subcategorize subjects whose views lie between grade 1 and 3 C\&L.
Analysis of the recorded videolaryngoscopic attempts will be performed later by a blinded researcher who was not involved with airway management.
- Conditions
- Airway Complication of Anesthesia
- Being tested
- head position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
head positionOther
head positioning in sniffing or flat position
| Study group | Role | What they receive |
|---|---|---|
| Group sniffing (S) | Active comparator | intervention: Head position changes : we will start by performing first videolaryngoscopy to find best view in flat position then the anesthesiologist will remove the Glidescope and the patient will be positioned in sniffing position using the pillow and another videolaryngoscopy will be attempted in sniffing position to find best view in this position and the patient will be intubated in this position. Receives: Other: head position |
| Group Flat (F) | Active comparator | intervention: Head position changes same procedure will be done but starting from sniffing position and the patient will be intubated in flat position. Receives: Other: head position |
What is being measured
The primary outcome is the main question the study is designed to answer.
optimal head position during videolaryngoscopy intubation
the optimum head position during videolaryngoscopy intubation will be successful first pass tracheal intubation.
Measured: intratracheal intubation procedure
Secondary outcomes (1)
best laryngeal exposure
the best laryngeal exposure (according to modified Cormack and Lehane classification) head position
Measured: intratracheal intubation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start1 Aug 2018
- Primary completion1 Feb 2019 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway Complication of 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in 2 groups: * Group sniffing (S): we will start by performing first videolaryngoscopy to find best view in flat position then the anesthesiologist will remove the Glidescope and the patient will be positioned in sniffing position using the pillow and another videolaryngoscopy will be attempted in sniffing position to find best view in this position and the patient will be intubated in this position. * Group flat (F): same procedure will be done but starting from sniffing position and the patient will be intubated in flat position.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Fahad Specialist Hospital Dammam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Munir Bamadhaj, King Fahad Specialist Hospital Dammam
- Investigators
- MUNIR H BAMADHAJ, MD, Principal investigator, King Fahad Specialist Hospital Dammam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810937
- Sponsor's protocol ID
- ANS004
- Status last verified
- Jan 2019
- First submitted
- 18 Jan 2019
- Last updated
- 25 Jan 2019
- Results posted
- 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 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Head and Neck Position for Videolaryngoscopy Intubation
- ClinicalTrials.gov ID
- NCT03810937
- Acronym / sponsor ID
- ANS004
- Conditions
- Airway Complication of Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- King Fahad Specialist Hospital DammamUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Feb 2019 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 22 Jan 2019 (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 introduction of videolaryngoscopy constituted a revolution in airway management since it could provide better laryngeal exposure (indirect) in situations of difficult or impossible visualization by direct laryngoscopy. The use of Videolaryngoscopes, however, does not always guarantee adequate exposure or end up always in successful tracheal intubation. Failed tracheal intubation with videolaryngoscopy has been reported. We hypothesized that may be the failure was due to omitting some preparatory steps, including optimal head positioning, leading to a less than expected exposure and/or difficult or impossible intubation. There are no recommendations currently from the scientific organizations regarding the optimal head position when using a GlideScope and it is unknown currently whether head position can affect visualization or tracheal intubation attempts when using this device.
Detailed description
- Multicentric,randomized, prospective and controlled study.
- After Institutional Review Board approval, signed written informed consents will be obtained from 165 adult patients with American Society of Anesthesiologists physical status 1-3 who are scheduled for elective surgery requiring endotracheal intubation.
- The following parameters will assessed and documented during the preoperative airway evaluation: BMI, mouth opening, thyromental distance, range of neck movement, and modified Mallampati classification. An 8cm non-compressible pillow.
- Patients will be randomized following coin toss into two groups depending on intubation position; Group Sniffing position(S) for obverse side and group flat position(F) for reverse side
- After premedication, American Society of Anesthesiologists' standard monitors will be applied, and preoxygenation for 3 to 5 minutes will be performed. After anesthesia induction and complete muscle relaxation as evidenced by loss of all evoked adductor pollicis responses to train of four stimulation of the ulnar nerve:
- Group sniffing (S): investigator will start by performing first videolaryngoscopy to find best view in flat position then the anesthesiologist will remove the Glidescope and the patient will be positioned in sniffing position using the pillow and another videolaryngoscopy will be attempted in sniffing position to find best view in this position and the patient will be intubated in this position.
- Group flat (F): same procedure will be done but starting from sniffing position and the patient will be intubated in flat position.
- The laryngoscopist will be asked not to use external laryngeal manipulation and to use the same lifting force throughout the study period. If these maneuvers deemed necessary for tracheal intubation (no visualization of vocal cords from full inflation to full deflation or the reverse, the laryngoscopist will be asked grade the view before applying the maneuver then use the required maneuver and record which intervention was needed and utilized.
- The estimated time to review theses different head elevation degrees is around 45 seconds.
- After preoxygenation technique we have a margin of 6 to 8 minutes of apnea without significant desaturation. Investigator will exclude also patients with high risk of desaturation (obesity and initial low saturation).
- The indirect laryngoscopic views will be graded using the same grading method used for direct laryngoscopy i.e. modified Cormack and Lehane. POGO score (percent of glottis opening viewed) will be also used to subcategorize subjects whose views lie between grade 1 and 3 C\&L.
Analysis of the recorded videolaryngoscopic attempts will be performed later by a blinded researcher who was not involved with airway management.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in 2 groups: * Group sniffing (S): we will start by performing first videolaryngoscopy to find best view in flat position then the anesthesiologist will remove the Glidescope and the patient will be positioned in sniffing position using the pillow and another videolaryngoscopy will be attempted in sniffing position to find best view in this position and the patient will be intubated in this position. * Group flat (F): same procedure will be done but starting from sniffing position and the patient will be intubated in flat position.
| Arm | Type | Receives |
|---|---|---|
| Group sniffing (S) | Active comparator | Other: head positionintervention: Head position changes : we will start by performing first videolaryngoscopy to find best view in flat position then the anesthesiologist will remove the Glidescope and the patient will be positioned in sniffing position using the pillow and another videolaryngoscopy will be attempted in sniffing position to find best view in this position and the patient will be intubated in this position. |
| Group Flat (F) | Active comparator | Other: head positionintervention: Head position changes same procedure will be done but starting from sniffing position and the patient will be intubated in flat position. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with American Society of Anesthesiologists physical status 1-3 who are scheduled for elective surgery requiring endotracheal intubation.
Key exclusion criteria (1 listed)
- history of difficult intubation, poor dentition, gastroesophageal reflux disease ,initial low oxygen saturation, severe/morbid obesity (body mass index [BMI] greater than 35 kg/m2),neck deformities, atlano-axial subluxation or at risk of aspiration.
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 |
|---|---|---|
| head positionhead positioning in sniffing or flat position | Other | Group Flat (F), Group sniffing (S) |
Primary outcome
optimal head position during videolaryngoscopy intubation
Time frame: intratracheal intubation procedure
the optimum head position during videolaryngoscopy intubation will be successful first pass tracheal intubation.
1 secondary outcome
best laryngeal exposure
Time frame: intratracheal intubation procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- Individual participant dataSharing planned: No
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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.
MUNIR H BAMADHAJ, MD principal investigator
King Fahad Specialist Hospital Dammam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing head position in people with Airway Complication of Anesthesia, run by King Fahad Specialist Hospital Dammam at 1 site in Saudi Arabia.
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: status not confirmed, as of the sponsor's last update on 25 Jan 2019. 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 Saudi Arabia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MUNIR H BAMADHAJ, MD (00966138442222 ext. 3993, MUNIR.BAMDHAJ@KFSH.MED.SA), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
optimal head position during videolaryngoscopy intubation (time frame: intratracheal intubation procedure). 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 Jan 2019.