Airway ManagementNCT04410289
Defining the 'Sniffing Position" in Infants and Toddlers - A Pilot Study
A study testing Airway positioning per specified protocol followed by Direct Laryngoscopy and Endotracheal Intubation and Airway positioning per provider preference followed by Direct Laryngoscopy and Endotracheal Intubation in people with Airway Management and Infant ALL, run by Tufts Medical Center at 1 site in United States.
Trial summary
The "sniffing position" is widely accepted as a favorable position for direct laryngoscopy (DL) in both pediatric and adult patients. External anatomical markers are well documented to confirm proper 'sniffing position' in adults, but data on their use in the pediatric population is sparse. Read more about this study
- Who is it for?
- Ages 1 month to 48 months
- Conditions the study is for
- Airway Management, Infant ALL, Children, Only
- What is being tested?
- Airway positioning per specified protocol followed by Direct Laryngoscopy and Endotracheal Intubation and Airway positioning per provider preference followed by Direct Laryngoscopy and Endotracheal Intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 26 Dec 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 1 month to 48 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- healthy infants and toddlers undergoing non-emergent surgery under general anesthesia with an oral endotracheal tube
Who cannot join
- neonates (infants under 1 month of age), infants and toddlers with congenital syndromes affecting the airway, and patients undergoing emergency surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Pilot Study to Define and Validate the Standard 'Sniffing Position' in Infants and Toddlers.
The "sniffing position" is widely accepted as a favorable position for direct laryngoscopy (DL) in both pediatric and adult patients. External anatomical markers are well documented to confirm proper 'sniffing position' in adults, but data on their use in the pediatric population is sparse. The investigators propose to define these markers in young children and investigate whether patients positioned using this standardized approach have better intubating conditions than those positioned randomly per the preference of the anesthesiologist.
Read the detailed description
The procedure of endotracheal intubation in adults and children is a continuum, and begins with proper head positioning prior to direct laryngoscopy (DL). It is an accepted paradigm that proper positioning optimizes intubating conditions, and decreases subsequent airway maneuvers and manipulation.
The sniffing position is an accepted airway positioning concept in pediatric airway management, and continues to be recommended by experts and textbooks in the field. Anatomical peculiarities such as the large head relative to the torso in infants and toddlers is assumed to put the head in proper position when gently extended. However, reproducible parameters to confirm optimal head positioning remain vague and unclear. In the absence of objective and measurable markers, practitioners position infants and toddlers according to their individual preferences, and as such the procedure lacks definition and objective clarity.
The investigators plan to recruit 40 healthy patients between the ages of 1 month - 48 months and randomize them to be positioned either according to a predetermined algorithm or positioned freely according to the provider's preference. Patients randomized to the intervention group will be positioned with the aim to horizontally align the external auditory meatus (EAM) with the sternal notch (SN).
In summary, the study aims to define the sniffing position for infants and toddlers using reproducible objective secondary markers, and investigate whether a systematic approach to positioning using such markers improves direct laryngoscopic outcomes in the young pediatric patient population.
- Conditions
- Airway Management, Infant ALL, Children, Only, Endotracheal Intubation
- Being tested
- Airway positioning per specified protocol followed by Direct Laryngoscopy and Endotracheal Intubation, Airway positioning per provider preference followed by Direct Laryngoscopy and Endotracheal Intubation
- Keywords
- pediatric intubation, direct laryngoscopy, sniffing position, external auditory meatus, pediatric anesthesia, pediatric airway management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway positioning per specified protocol followed by Direct Laryngoscopy and Endotracheal IntubationProcedure or surgery
Positioning of the patient's head and neck for the purpose of direct laryngoscopy and endotracheal intubation
Airway positioning per provider preference followed by Direct Laryngoscopy and Endotracheal IntubationProcedure or surgery
Positioning of the patient's head and neck for the purpose of direct laryngoscopy and endotracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | After induction of general anesthesia, and prior to direct laryngoscopy, patients in the intervention group were positioned using props horizontally aligning the external auditory meatus (EAM) with the sternal notch (SN) and the chin with the sinciput. A lateral side-profile photograph was taken for latter analysis and an Intubation Difficulty Scale (IDS) score card completed. Receives: Procedure: Airway positioning per specified protocol followed by Direct Laryngoscopy and Endotracheal Intubation |
| Control Group | Active comparator | After induction of general anesthesia, and prior to direct laryngoscopy, patients in the control group were positioned freely according to the provider's preference. A lateral side-profile photograph was taken for latter analysis and an Intubation Difficulty Scale (IDS) score card completed. Receives: Procedure: Airway positioning per provider preference followed by Direct Laryngoscopy and Endotracheal Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Intubation Difficulty Scale (IDS) Score
To assess the difference in IDS scores between the study and control groups
Measured: The brief time involved (5-10 minutes) involving the process of head positioning, direct laryngoscopy and endotracheal intubation.
Secondary outcomes (1)
Angles of Deviation of the EAM-SN plane and Chin-Sinciput Plane from the Horizontal
Secondary outcome was to analyze and compare the degree of alignment or nonalignment of the EAM-SN plane and the sinciput-chin plane in both groups. Angles of deviation of the EAM-SN and chin-sinciput plane were measured in each cohort based on photographic data collected. A positive angle deviation indicated head flexion and a negative angle indicated head extension.
Measured: Post-hoc analysis using a computer program to calculate angles. 10 minutes per patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start1 Jul 2019
- Primary completion30 Nov 2019
- Study completion26 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Airway ManagementStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aman Kalra, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410289
- Sponsor's protocol ID
- 13188
- Status last verified
- Jun 2020
- First submitted
- 26 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Akihisa Y, Hoshijima H, Maruyama K, Koyama Y, Andoh T. Effects of sniffing position for tracheal intubation: a meta-analysis of randomized controlled trials. Am J Emerg Med. 2015 Nov;33(11):1606-11. doi: 10.1016/j.ajem.2015.06.049. Epub 2015 Jun 23.
PubMed 26227445El-Orbany M, Woehlck H, Salem MR. Head and neck position for direct laryngoscopy. Anesth Analg. 2011 Jul;113(1):103-9. doi: 10.1213/ANE.0b013e31821c7e9c. Epub 2011 May 19.
PubMed 21596871Greenland KB, Eley V, Edwards MJ, Allen P, Irwin MG. The origins of the sniffing position and the Three Axes Alignment Theory for direct laryngoscopy. Anaesth Intensive Care. 2008 Jul;36 Suppl 1:23-7. doi: 10.1177/0310057X0803601s05.
PubMed 18724555Greenland KB, Edwards MJ, Hutton NJ. External auditory meatus-sternal notch relationship in adults in the sniffing position: a magnetic resonance imaging study. Br J Anaesth. 2010 Feb;104(2):268-9. doi: 10.1093/bja/aep390. No abstract available.
PubMed 20086071Prakash S, Rapsang AG, Mahajan S, Bhattacharjee S, Singh R, Gogia AR. Comparative evaluation of the sniffing position with simple head extension for laryngoscopic view and intubation difficulty in adults undergoing elective surgery. Anesthesiol Res Pract. 2011;2011:297913. doi: 10.1155/2011/297913. Epub 2011 Oct 29.
PubMed 22110497Collins JS, Lemmens HJ, Brodsky JB, Brock-Utne JG, Levitan RM. Laryngoscopy and morbid obesity: a comparison of the "sniff" and "ramped" positions. Obes Surg. 2004 Oct;14(9):1171-5. doi: 10.1381/0960892042386869.
PubMed 15527629Horton WA, Fahy L, Charters P. Defining a standard intubating position using "angle finder". Br J Anaesth. 1989 Jan;62(1):6-12. doi: 10.1093/bja/62.1.6.
PubMed 2917111Kim EH, Lee JH, Song IK, Kim JT, Kim BR, Kim HS. Effect of head position on laryngeal visualisation with the McGrath MAC videolaryngoscope in paediatric patients: A randomised controlled trial. Eur J Anaesthesiol. 2016 Jul;33(7):528-34. doi: 10.1097/EJA.0000000000000448.
PubMed 26986776Vialet R, Nau A, Chaumoitre K, Martin C. Effects of head posture on the oral, pharyngeal and laryngeal axis alignment in infants and young children by magnetic resonance imaging. Paediatr Anaesth. 2008 Jun;18(6):525-31. doi: 10.1111/j.1460-9592.2008.02530.x. Epub 2008 Mar 18.
PubMed 18363622Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.
PubMed 9416711Greenland 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 20846964
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Pilot Study to Define and Validate the Standard 'Sniffing Position' in Infants and Toddlers.
- ClinicalTrials.gov ID
- NCT04410289
- Acronym / sponsor ID
- 13188
- Conditions
- Airway Management, Infant ALL, Children, Only, Endotracheal Intubation
- Keywords
- pediatric intubation, direct laryngoscopy, sniffing position, external auditory meatus, pediatric anesthesia, pediatric airway management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 26 Dec 2019 (actual)
- First posted
- 1 Jun 2020 (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 "sniffing position" is widely accepted as a favorable position for direct laryngoscopy (DL) in both pediatric and adult patients. External anatomical markers are well documented to confirm proper 'sniffing position' in adults, but data on their use in the pediatric population is sparse. The investigators propose to define these markers in young children and investigate whether patients positioned using this standardized approach have better intubating conditions than those positioned randomly per the preference of the anesthesiologist.
Detailed description
The procedure of endotracheal intubation in adults and children is a continuum, and begins with proper head positioning prior to direct laryngoscopy (DL). It is an accepted paradigm that proper positioning optimizes intubating conditions, and decreases subsequent airway maneuvers and manipulation.
The sniffing position is an accepted airway positioning concept in pediatric airway management, and continues to be recommended by experts and textbooks in the field. Anatomical peculiarities such as the large head relative to the torso in infants and toddlers is assumed to put the head in proper position when gently extended. However, reproducible parameters to confirm optimal head positioning remain vague and unclear. In the absence of objective and measurable markers, practitioners position infants and toddlers according to their individual preferences, and as such the procedure lacks definition and objective clarity.
The investigators plan to recruit 40 healthy patients between the ages of 1 month - 48 months and randomize them to be positioned either according to a predetermined algorithm or positioned freely according to the provider's preference. Patients randomized to the intervention group will be positioned with the aim to horizontally align the external auditory meatus (EAM) with the sternal notch (SN).
In summary, the study aims to define the sniffing position for infants and toddlers using reproducible objective secondary markers, and investigate whether a systematic approach to positioning using such markers improves direct laryngoscopic outcomes in the young pediatric patient population.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Procedure: Airway positioning per specified protocol followed by Direct Laryngoscopy and Endotracheal IntubationAfter induction of general anesthesia, and prior to direct laryngoscopy, patients in the intervention group were positioned using props horizontally aligning the external auditory meatus (EAM) with the sternal notch (SN) and the chin with the sinciput. A lateral side-profile photograph was taken for latter analysis and an Intubation Difficulty Scale (IDS) score card completed. |
| Control Group | Active comparator | Procedure: Airway positioning per provider preference followed by Direct Laryngoscopy and Endotracheal IntubationAfter induction of general anesthesia, and prior to direct laryngoscopy, patients in the control group were positioned freely according to the provider's preference. A lateral side-profile photograph was taken for latter analysis and an Intubation Difficulty Scale (IDS) score card completed. |
Who may qualify
- Ages
- 1 month to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- healthy infants and toddlers undergoing non-emergent surgery under general anesthesia with an oral endotracheal tube
Key exclusion criteria (1 listed)
- neonates (infants under 1 month of age), infants and toddlers with congenital syndromes affecting the airway, and patients undergoing emergency surgery.
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 |
|---|---|---|
| Airway positioning per specified protocol followed by Direct Laryngoscopy and Endotracheal IntubationPositioning of the patient's head and neck for the purpose of direct laryngoscopy and endotracheal intubation | Procedure or surgery | Intervention Group |
| Airway positioning per provider preference followed by Direct Laryngoscopy and Endotracheal IntubationPositioning of the patient's head and neck for the purpose of direct laryngoscopy and endotracheal intubation | Procedure or surgery | Control Group |
Primary outcome
Difference in Intubation Difficulty Scale (IDS) Score
Time frame: The brief time involved (5-10 minutes) involving the process of head positioning, direct laryngoscopy and endotracheal intubation.
To assess the difference in IDS scores between the study and control groups
1 secondary outcome
Angles of Deviation of the EAM-SN plane and Chin-Sinciput Plane from the Horizontal
Time frame: Post-hoc analysis using a computer program to calculate angles. 10 minutes per patient.
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 4 Jun 2020.
- Background: PubMed 26227445Akihisa Y, Hoshijima H, Maruyama K, Koyama Y, Andoh T. Effects of sniffing position for tracheal intubation: a meta-analysis of randomized controlled trials. Am J Emerg Med. 2015 Nov;33(11):1606-11. doi: 10.1016/j.ajem.2015.06.049. Epub 2015 Jun 23.
- Background: PubMed 21596871El-Orbany M, Woehlck H, Salem MR. Head and neck position for direct laryngoscopy. Anesth Analg. 2011 Jul;113(1):103-9. doi: 10.1213/ANE.0b013e31821c7e9c. Epub 2011 May 19.
- Background: PubMed 18724555Greenland KB, Eley V, Edwards MJ, Allen P, Irwin MG. The origins of the sniffing position and the Three Axes Alignment Theory for direct laryngoscopy. Anaesth Intensive Care. 2008 Jul;36 Suppl 1:23-7. doi: 10.1177/0310057X0803601s05.
- Background: PubMed 20086071Greenland KB, Edwards MJ, Hutton NJ. External auditory meatus-sternal notch relationship in adults in the sniffing position: a magnetic resonance imaging study. Br J Anaesth. 2010 Feb;104(2):268-9. doi: 10.1093/bja/aep390. No abstract available.
- Background: PubMed 22110497Prakash S, Rapsang AG, Mahajan S, Bhattacharjee S, Singh R, Gogia AR. Comparative evaluation of the sniffing position with simple head extension for laryngoscopic view and intubation difficulty in adults undergoing elective surgery. Anesthesiol Res Pract. 2011;2011:297913. doi: 10.1155/2011/297913. Epub 2011 Oct 29.
- Background: PubMed 15527629Collins JS, Lemmens HJ, Brodsky JB, Brock-Utne JG, Levitan RM. Laryngoscopy and morbid obesity: a comparison of the "sniff" and "ramped" positions. Obes Surg. 2004 Oct;14(9):1171-5. doi: 10.1381/0960892042386869.
- Background: PubMed 2917111Horton WA, Fahy L, Charters P. Defining a standard intubating position using "angle finder". Br J Anaesth. 1989 Jan;62(1):6-12. doi: 10.1093/bja/62.1.6.
- Background: PubMed 26986776Kim EH, Lee JH, Song IK, Kim JT, Kim BR, Kim HS. Effect of head position on laryngeal visualisation with the McGrath MAC videolaryngoscope in paediatric patients: A randomised controlled trial. Eur J Anaesthesiol. 2016 Jul;33(7):528-34. doi: 10.1097/EJA.0000000000000448.
- Background: PubMed 18363622Vialet R, Nau A, Chaumoitre K, Martin C. Effects of head posture on the oral, pharyngeal and laryngeal axis alignment in infants and young children by magnetic resonance imaging. Paediatr Anaesth. 2008 Jun;18(6):525-31. doi: 10.1111/j.1460-9592.2008.02530.x. Epub 2008 Mar 18.
- Background: PubMed 9416711Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.
- 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.
- Individual participant dataSharing planned: Undecided
Related trials for Airway Management
Not yet recruiting
Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
Airway Management
Not yet recruitingObservational study
AI-assisted Tracheal Intubation in Children
Intubation
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Not yet recruitingObservational study
Preoperative Frailty and Suboptimal Mask Ventilation in Cardiac Surgery Patients
Frailty, Suboptimal Mask Ventilation
Not yet recruitingPhase 2
A Study to Assess the Efficacy and Safety of Co-administration of GSK3862995B With GSK5784283 in Adult Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
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.
Aman Kalra, MD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airway positioning per specified protocol followed by Direct Laryngoscopy and Endotracheal Intubation and Airway positioning per provider preference followed by Direct Laryngoscopy and Endotracheal Intubation in people with Airway Management and Infant ALL, run by Tufts Medical Center 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 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 4 Jun 2020. 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?
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?
Difference in Intubation Difficulty Scale (IDS) Score (time frame: The brief time involved (5-10 minutes) involving the process of head positioning, direct laryngoscopy and endotracheal intubation.). 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 NCT04410289, which also lists 11 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 4 Jun 2020.