NeonatesNCT07444528
Upper Airway Ultrasound to Predict Difficult Laryngoscopy in Neonates and Infants
An observational study of Neonates and Infants Aged 0 Days to 12 Months Scheduled for Elective Surgery, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
Upper airway ultrasound (UA-US) has been utilized in adults to predict difficult laryngoscopy (Cormick-Lehane view 3 or 4) and difficult tracheal intubation (DTI) (≥3 intubation attempts) and with moderate-to-high sensitivity and specificity. Read more about this study
- Who is it for?
- Ages Up to 365 daysHealthy volunteers can take part
- Conditions the study is for
- Neonates, Infants Aged 0 Days to 12 Months Scheduled for Elective Surgery
- What is being tested?
- Upper airway ultrasound
- Type of treatment
- Pill or oral medicine
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 365 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Neonates and infants presenting for diagnostic or procedural care under general anesthesia requiring oral endotracheal intubation with video laryngoscopy and neuromuscular blockade.
Who may be able to join
- Neonates (chronological age 30 days) and infants (31 days to 365 days)
- ASA physical status I-IV
- Oral endotracheal intubation for surgical, diagnostic or interventional procedures with neuromuscular blockade
- Video laryngoscopy
- Patients with previously classified non-difficult airway (previous easy intubation)
- Patients with a previously classified difficult airway
- Patients with congenital heart disease
- Parental/guardian permission
Who cannot join
- ASA ≥V
- Emergency procedure
- Unable to be placed in supine position for study ultrasound
- Need for rapid sequence induction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Upper Airway Ultrasound to Predict Difficult Airway Management in Neonates and Infants: A Prospective Observational Study
Upper airway ultrasound (UA-US) has been utilized in adults to predict difficult laryngoscopy (Cormick-Lehane view 3 or 4) and difficult tracheal intubation (DTI) (≥3 intubation attempts) and with moderate-to-high sensitivity and specificity. This bedside technique is reproducible, easy-to-do without any additional radiation risk, and was added to the most recent American Society of Anesthesiologists (ASA) Practice Guidelines for Difficult Airway Management in Adults. However, UA-US has only been applied to older children ages 5-12 and has not been examined in neonates and infants. Thus, the aim of this observational study using UA-US to predict difficult laryngoscopy and tracheal intubation in neonates and infants presenting for diagnostic, procedural or surgical care under general anesthesia requiring endotracheal intubation.
Read the detailed description
Neonates and infants have a higher incidence of difficult laryngoscopy and DTI compared to older children and adults. Classical methods of screening for difficult laryngoscopy or DTI in adults, such as a Mallampati score, thyromental distance, and neck circumference are poorly applied to our smallest patients. UA-US has emerged as a technique to measure several UA parameters at the bedside with impressive sensitivity and specificity for identifying a difficult airway in adult patients, with higher UA-US measurements correlating with higher Cormick-Lehane laryngoscopy scores. UA-US was recently added to the 2022 ASA Practice Guidelines for Difficult Airway Management, specifically distance from the skin to the epiglottis (DSE), distance from the skin to the hyoid bone (DSHB), and tongue thickness (TTh). While UA-US has been minimally studied in children, one study showed high positive and negative predictive values for DTI with DSE and hyomental distance (HMD) in children aged 5-12 years. UA-US has the potential to identify unanticipated difficult airways in neonates and infants but has not been studied in this vulnerable population.
Despite the adoption of video laryngoscopy (VL) for intubation of neonates and infants in many clinical settings, there remains a substantial incidence of difficult glottic exposure and DTI. Garcia-Marcinkiewicz et al. found an incidence of difficult laryngoscopy, defined as a percentage of glottic opening (POGO) score <100 in 33% of neonates and infants intubated with VL. The NEonatal and Children AudiT of Anaesthesia pRactice (NECTARINE) trial, a multicenter prospective study performed in Europe, found a DTI rate of 5.8% amongst neonates and infants requiring intubation for a surgical procedure. Of these difficult intubations, nearly 70% were unplanned, unanticipated difficult airways. Repeated attempts at intubation are correlated with an increased rate of serious complications like severe hypoxemia, airway trauma, and cardiac arrest, and those youngest in age are at highest risk. Unanticipated difficult airways are more likely to increase the number of tracheal intubation attempts required for success.
UA-US could be utilized as a non-invasive, bedside tool to screen neonates and infants for unanticipated difficult laryngoscopy and intubation, facilitating multidisciplinary airway planning, in and out of the operating room, potentially reducing the need for multiple intubation attempts and patient harm. However, UA-US has never been applied to this patient population. This would be an innovative application of a point-of-care ultrasound modality that is currently being utilized in multiple adult care settings (operating room, emergency department and intensive care units). UA-US has similarly broad potential functions in pediatric medicine that are currently being underutilized.
As this is a novel application of this technique in this patient population, the aims of this study are to examine the differences in distribution of UA-US measurements between neonates and infants with and without difficult glottic exposure (POGO score 0-50%) with VL. In adult studies, direct laryngoscopy (DL) is commonly used and difficulty of laryngoscopy typically graded using the Cormick-Lehane grading scale (I-IV). However, airway management differs in neonates and infants. The First-Attempt Success Rate of Video Laryngoscopy In Small Infants (VISI) trial performed in 2020 found a significantly higher success rate of first-intubation success utilizing VL over DL (93% versus 88%, P=0.024.) in neonates and infant presenting for tracheal intubation during surgery. As a result, VL is considered standard of care in this patient population. Further, to test whether UA-US measurements correlate accurately to difficult laryngoscopy and DTI, it is pertinent to standardize the intubation technique to reduce confounding.
The investigators hypothesize that higher UA-US values will be associated with higher odds of having worse POGO scores in neonates and infants intubated with VL.
- Being tested
- Upper airway ultrasound
- Keywords
- point of care ultrasound, airway ultrasound, difficult intubation, pediatric intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper airway ultrasoundOther
The investigator will perform 6 UA-US measurements will be obtained with a high frequency linear array or curvilinear US probe following induction of anesthesia but prior to laryngoscopy or TI: distance from the skin to the epiglottis, distance from the skin to the hyoid bone, distance from skin to vocal cords, hyomental distance, tongue thickness, and tongue cross-sectional area.
| Study group | Role | What they receive |
|---|---|---|
| neonates and infants requiring oral tracheal intubation with VL and neuromuscular blockade | The investigator will perform 6 UA-US measurements will be obtained with a high frequency linear array or curvilinear US probe following induction of anesthesia but prior to laryngoscopy or TI: distance from the skin to the epiglottis, distance from the skin to the hyoid bone, distance from skin to vocal cords, hyomental distance, tongue thickness, and tongue cross-sectional area.
Following UA-US, oral tracheal intubation will occur with VL and neuromuscular blockade as clinical standard of care. At the time of tracheal intubation, the study team will record the percent of glottic opening (POGO) score and additional study endpoints. Receives: Other: Upper airway ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Glottic Opening (POGO) score
(0-25%; >25-50%; >50-75%; >75-100%). Lower POGO scores correlate with a worse view of the glottic opening (Cormack-Lehane III-IV) and difficult laryngoscopy.
Measured: From enrollment to the end of successful tracheal intubation, approximately 30 minutes.
Secondary outcomes (4)
Difficult tracheal intubation
> or = 3 intubation attempts
Measured: From enrollment to the end of successful tracheal intubation, approximately 30 minutes.
Time to successful intubation in seconds
Time from laryngoscope insertion to confirmation of endotracheal tube (ETT) placement/end tidal capnography
Measured: From enrollment to the end of successful tracheal intubation, approximately 30 minutes.
First attempt success
Number of intubations successful on the first-attempt
Measured: From enrollment to the end of successful tracheal intubation, approximately 30 minutes.
Use of advancement maneuvers
Shift blade left, laryngoscope blade retracted or pulled back blade, ETT receded and then advanced
Measured: From enrollment to the end of successful tracheal intubation, approximately 30 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start2 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for NeonatesStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth M O'Brien, MD, MAS, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444528
- Sponsor's protocol ID
- 25-023870
- Other IDs
- PRJ-00001922
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Corder W, Nelin T, Ades AM, Flibotte J, Laverriere E, Daly Guris R, Soorikian L, Foglia EE. Association between video laryngoscopy characteristics and successful neonatal tracheal intubation: a prospective study. Arch Dis Child Fetal Neonatal Ed. 2024 Jul 1:fetalneonatal-2024-326992. doi: 10.1136/fetalneonatal-2024-326992. Online ahead of print.
PubMed 38951017Haubner LY, Barry JS, Johnston LC, Soghier L, Tatum PM, Kessler D, Downes K, Auerbach M. Neonatal intubation performance: room for improvement in tertiary neonatal intensive care units. Resuscitation. 2013 Oct;84(10):1359-64. doi: 10.1016/j.resuscitation.2013.03.014. Epub 2013 Apr 3.
PubMed 23562374Benumof JL, Cooper SD. Quantitative improvement in laryngoscopic view by optimal external laryngeal manipulation. J Clin Anesth. 1996 Mar;8(2):136-40. doi: 10.1016/0952-8180(95)00198-0.
PubMed 8695096Bacon ER, Phelan MP, Doyle DJ. Tips and Troubleshooting for Use of the GlideScope Video Laryngoscope for Emergency Endotracheal Intubation. Am J Emerg Med. 2015 Sep;33(9):1273-7. doi: 10.1016/j.ajem.2015.05.003. Epub 2015 May 13.
PubMed 26008581Andruszkiewicz P, Wojtczak J, Sobczyk D, Stach O, Kowalik I. Effectiveness and Validity of Sonographic Upper Airway Evaluation to Predict Difficult Laryngoscopy. J Ultrasound Med. 2016 Oct;35(10):2243-52. doi: 10.7863/ultra.15.11098. Epub 2016 Aug 31.
PubMed 27582532Wu J, Dong J, Ding Y, Zheng J. Role of anterior neck soft tissue quantifications by ultrasound in predicting difficult laryngoscopy. Med Sci Monit. 2014 Nov 18;20:2343-50. doi: 10.12659/MSM.891037.
PubMed 25403231Adhikari S, Zeger W, Schmier C, Crum T, Craven A, Frrokaj I, Pang H, Shostrom V. Pilot study to determine the utility of point-of-care ultrasound in the assessment of difficult laryngoscopy. Acad Emerg Med. 2011 Jul;18(7):754-8. doi: 10.1111/j.1553-2712.2011.01099.x. Epub 2011 Jun 27.
PubMed 21707828Pinto J, Cordeiro L, Pereira C, Gama R, Fernandes HL, Assuncao J. Predicting difficult laryngoscopy using ultrasound measurement of distance from skin to epiglottis. J Crit Care. 2016 Jun;33:26-31. doi: 10.1016/j.jcrc.2016.01.029. Epub 2016 Feb 11.
PubMed 26948251Carsetti A, Sorbello M, Adrario E, Donati A, Falcetta S. Airway Ultrasound as Predictor of Difficult Direct Laryngoscopy: A Systematic Review and Meta-analysis. Anesth Analg. 2022 Apr 1;134(4):740-750. doi: 10.1213/ANE.0000000000005839.
PubMed 34914641Fernandez-Vaquero MA, De Luis-Cabezon N, Garcia-Aroca MA, Alvarez-Avello JM, Vives-Santacana M, Greif R, Martinez-Hurtado ED, Ly-Liu D. Pilot multicenter study to determine the utility of point-of-care ultrasound to predict difficulty of tracheal intubation using videolaryngoscopy with the McGrath Mac videolaryngoscope. Front Med (Lausanne). 2024 Jul 19;11:1406676. doi: 10.3389/fmed.2024.1406676. eCollection 2024.
PubMed 39099593Levitan RM, Ochroch EA, Kush S, Shofer FS, Hollander JE. Assessment of airway visualization: validation of the percentage of glottic opening (POGO) scale. Acad Emerg Med. 1998 Sep;5(9):919-23. doi: 10.1111/j.1553-2712.1998.tb02823.x.
PubMed 9754506Lee JH, Turner DA, Kamat P, Nett S, Shults J, Nadkarni VM, Nishisaki A; Pediatric Acute Lung Injury and Sepsis Investigators (PALISI); National Emergency Airway Registry for Children (NEAR4KIDS). The number of tracheal intubation attempts matters! A prospective multi-institutional pediatric observational study. BMC Pediatr. 2016 Apr 29;16:58. doi: 10.1186/s12887-016-0593-y.
PubMed 27130327Graciano AL, Tamburro R, Thompson AE, Fiadjoe J, Nadkarni VM, Nishisaki A. Incidence and associated factors of difficult tracheal intubations in pediatric ICUs: a report from National Emergency Airway Registry for Children: NEAR4KIDS. Intensive Care Med. 2014 Nov;40(11):1659-69. doi: 10.1007/s00134-014-3407-4. Epub 2014 Aug 27.
PubMed 25160031Disma N, Virag K, Riva T, Kaufmann J, Engelhardt T, Habre W; NECTARINE Group of the European Society of Anaesthesiology Clinical Trial Network; AUSTRIA (Maria Vittinghoff); BELGIUM (Francis Veyckemans); CROATIA (Sandra Kralik); CZECH REPUBLIC (Jiri Zurek); DENMARK (Tom Hansen); ESTONIA (Reet Kikas); FINLAND (Tuula Manner); FRANCE (Christophe Dadure, Anne Lafargue); GERMANY (Karin Becke, Claudia Hoehne); GREECE (Anna Malisiova); HUNGARY (Andrea Szekely); IRELAND (Brendan O'Hare); ITALY (Nicola Disma); LATVIA (Zane Straume); LITHUANIA (Laura Lukosiene); LUXEMBOURG (Bernd Schmitz); MALTA (Francis Borg); NETHERLANDS (Jurgen de Graaff); NORWAY (Wenche B Boerke); POLAND (Marzena Zielinska); PORTUGAL (Maria Domingas Patuleia); ROMANIA (Radu Tabacaru); SERBIA (Dusica Simic); SLOVAKIA (Miloslav Hanula); SLOVENIA (Jelena Berger); SPAIN (Ignacio Galvez Escalera); SWEDEN (Albert Castellheim); SWITZERLAND (Walid Habre); TURKEY (Dilek Ozcengiz - Zehra Hatipoglu); UKRAINE (Dmytro Dmytriiev); UNITED KINGDOM (Thomas Engelhardt, Suellen Walker); Management Team. Difficult tracheal intubation in neonates and infants. NEonate and Children audiT of Anaesthesia pRactice IN Europe (NECTARINE): a prospective European multicentre observational study. Br J Anaesth. 2021 Jun;126(6):1173-1181. doi: 10.1016/j.bja.2021.02.021. Epub 2021 Apr 1.
PubMed 33812665Garcia-Marcinkiewicz AG, Kovatsis PG, Hunyady AI, Olomu PN, Zhang B, Sathyamoorthy M, Gonzalez A, Kanmanthreddy S, Galvez JA, Franz AM, Peyton J, Park R, Kiss EE, Sommerfield D, Griffis H, Nishisaki A, von Ungern-Sternberg BS, Nadkarni VM, McGowan FX Jr, Fiadjoe JE; PeDI Collaborative investigators. First-attempt success rate of video laryngoscopy in small infants (VISI): a multicentre, randomised controlled trial. Lancet. 2020 Dec 12;396(10266):1905-1913. doi: 10.1016/S0140-6736(20)32532-0.
PubMed 33308472
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Airway Ultrasound to Predict Difficult Airway Management in Neonates and Infants: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07444528
- Acronym / sponsor ID
- 25-023870
- Keywords
- point of care ultrasound, airway ultrasound, difficult intubation, pediatric intubation
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Mar 2026 (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.
Upper airway ultrasound (UA-US) has been utilized in adults to predict difficult laryngoscopy (Cormick-Lehane view 3 or 4) and difficult tracheal intubation (DTI) (≥3 intubation attempts) and with moderate-to-high sensitivity and specificity. This bedside technique is reproducible, easy-to-do without any additional radiation risk, and was added to the most recent American Society of Anesthesiologists (ASA) Practice Guidelines for Difficult Airway Management in Adults. However, UA-US has only been applied to older children ages 5-12 and has not been examined in neonates and infants. Thus, the aim of this observational study using UA-US to predict difficult laryngoscopy and tracheal intubation in neonates and infants presenting for diagnostic, procedural or surgical care under general anesthesia requiring endotracheal intubation.
Detailed description
Neonates and infants have a higher incidence of difficult laryngoscopy and DTI compared to older children and adults. Classical methods of screening for difficult laryngoscopy or DTI in adults, such as a Mallampati score, thyromental distance, and neck circumference are poorly applied to our smallest patients. UA-US has emerged as a technique to measure several UA parameters at the bedside with impressive sensitivity and specificity for identifying a difficult airway in adult patients, with higher UA-US measurements correlating with higher Cormick-Lehane laryngoscopy scores. UA-US was recently added to the 2022 ASA Practice Guidelines for Difficult Airway Management, specifically distance from the skin to the epiglottis (DSE), distance from the skin to the hyoid bone (DSHB), and tongue thickness (TTh). While UA-US has been minimally studied in children, one study showed high positive and negative predictive values for DTI with DSE and hyomental distance (HMD) in children aged 5-12 years. UA-US has the potential to identify unanticipated difficult airways in neonates and infants but has not been studied in this vulnerable population.
Despite the adoption of video laryngoscopy (VL) for intubation of neonates and infants in many clinical settings, there remains a substantial incidence of difficult glottic exposure and DTI. Garcia-Marcinkiewicz et al. found an incidence of difficult laryngoscopy, defined as a percentage of glottic opening (POGO) score <100 in 33% of neonates and infants intubated with VL. The NEonatal and Children AudiT of Anaesthesia pRactice (NECTARINE) trial, a multicenter prospective study performed in Europe, found a DTI rate of 5.8% amongst neonates and infants requiring intubation for a surgical procedure. Of these difficult intubations, nearly 70% were unplanned, unanticipated difficult airways. Repeated attempts at intubation are correlated with an increased rate of serious complications like severe hypoxemia, airway trauma, and cardiac arrest, and those youngest in age are at highest risk. Unanticipated difficult airways are more likely to increase the number of tracheal intubation attempts required for success.
UA-US could be utilized as a non-invasive, bedside tool to screen neonates and infants for unanticipated difficult laryngoscopy and intubation, facilitating multidisciplinary airway planning, in and out of the operating room, potentially reducing the need for multiple intubation attempts and patient harm. However, UA-US has never been applied to this patient population. This would be an innovative application of a point-of-care ultrasound modality that is currently being utilized in multiple adult care settings (operating room, emergency department and intensive care units). UA-US has similarly broad potential functions in pediatric medicine that are currently being underutilized.
As this is a novel application of this technique in this patient population, the aims of this study are to examine the differences in distribution of UA-US measurements between neonates and infants with and without difficult glottic exposure (POGO score 0-50%) with VL. In adult studies, direct laryngoscopy (DL) is commonly used and difficulty of laryngoscopy typically graded using the Cormick-Lehane grading scale (I-IV). However, airway management differs in neonates and infants. The First-Attempt Success Rate of Video Laryngoscopy In Small Infants (VISI) trial performed in 2020 found a significantly higher success rate of first-intubation success utilizing VL over DL (93% versus 88%, P=0.024.) in neonates and infant presenting for tracheal intubation during surgery. As a result, VL is considered standard of care in this patient population. Further, to test whether UA-US measurements correlate accurately to difficult laryngoscopy and DTI, it is pertinent to standardize the intubation technique to reduce confounding.
The investigators hypothesize that higher UA-US values will be associated with higher odds of having worse POGO scores in neonates and infants intubated with VL.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neonates and infants requiring oral tracheal intubation with VL and neuromuscular blockade | – | Other: Upper airway ultrasoundThe investigator will perform 6 UA-US measurements will be obtained with a high frequency linear array or curvilinear US probe following induction of anesthesia but prior to laryngoscopy or TI: distance from the skin to the epiglottis, distance from the skin to the hyoid bone, distance from skin to vocal cords, hyomental distance, tongue thickness, and tongue cross-sectional area. Following UA-US, oral tracheal intubation will occur with VL and neuromuscular blockade as clinical standard of care. At the time of tracheal intubation, the study team will record the percent of glottic opening (POGO) score and additional study endpoints. |
Who may qualify
- Ages
- Up to 365 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Neonates and infants presenting for diagnostic or procedural care under general anesthesia requiring oral endotracheal intubation with video laryngoscopy and neuromuscular blockade.
Key inclusion criteria (8 listed)
- Neonates (chronological age 30 days) and infants (31 days to 365 days)
- ASA physical status I-IV
- Oral endotracheal intubation for surgical, diagnostic or interventional procedures with neuromuscular blockade
- Video laryngoscopy
- Patients with previously classified non-difficult airway (previous easy intubation)
Key exclusion criteria (4 listed)
- ASA ≥V
- Emergency procedure
- Unable to be placed in supine position for study ultrasound
- Need for rapid sequence induction
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 |
|---|---|---|
| Upper airway ultrasoundThe investigator will perform 6 UA-US measurements will be obtained with a high frequency linear array or curvilinear US probe following induction of anesthesia but prior to laryngoscopy or TI: distance from the skin to the epiglottis, distance from the skin to the hyoid bone, distance from skin to vocal cords, hyomental distance, tongue thickness, and tongue cross-sectional area. | Other | neonates and infants requiring oral tracheal intubation with VL and neuromuscular blockade |
Primary outcome
Percentage of Glottic Opening (POGO) score
Time frame: From enrollment to the end of successful tracheal intubation, approximately 30 minutes.
(0-25%; >25-50%; >50-75%; >75-100%). Lower POGO scores correlate with a worse view of the glottic opening (Cormack-Lehane III-IV) and difficult laryngoscopy.
4 secondary outcomes
Difficult tracheal intubation
Time frame: From enrollment to the end of successful tracheal intubation, approximately 30 minutes.
Time to successful intubation in seconds
Time frame: From enrollment to the end of successful tracheal intubation, approximately 30 minutes.
First attempt success
Time frame: From enrollment to the end of successful tracheal intubation, approximately 30 minutes.
Use of advancement maneuvers
Time frame: From enrollment to the end of successful tracheal intubation, approximately 30 minutes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Background: PubMed 38951017Corder W, Nelin T, Ades AM, Flibotte J, Laverriere E, Daly Guris R, Soorikian L, Foglia EE. Association between video laryngoscopy characteristics and successful neonatal tracheal intubation: a prospective study. Arch Dis Child Fetal Neonatal Ed. 2024 Jul 1:fetalneonatal-2024-326992. doi: 10.1136/fetalneonatal-2024-326992. Online ahead of print.
- Background: PubMed 23562374Haubner LY, Barry JS, Johnston LC, Soghier L, Tatum PM, Kessler D, Downes K, Auerbach M. Neonatal intubation performance: room for improvement in tertiary neonatal intensive care units. Resuscitation. 2013 Oct;84(10):1359-64. doi: 10.1016/j.resuscitation.2013.03.014. Epub 2013 Apr 3.
- Background: PubMed 8695096Benumof JL, Cooper SD. Quantitative improvement in laryngoscopic view by optimal external laryngeal manipulation. J Clin Anesth. 1996 Mar;8(2):136-40. doi: 10.1016/0952-8180(95)00198-0.
- Background: PubMed 26008581Bacon ER, Phelan MP, Doyle DJ. Tips and Troubleshooting for Use of the GlideScope Video Laryngoscope for Emergency Endotracheal Intubation. Am J Emerg Med. 2015 Sep;33(9):1273-7. doi: 10.1016/j.ajem.2015.05.003. Epub 2015 May 13.
- Background: PubMed 27582532Andruszkiewicz P, Wojtczak J, Sobczyk D, Stach O, Kowalik I. Effectiveness and Validity of Sonographic Upper Airway Evaluation to Predict Difficult Laryngoscopy. J Ultrasound Med. 2016 Oct;35(10):2243-52. doi: 10.7863/ultra.15.11098. Epub 2016 Aug 31.
- Background: PubMed 25403231Wu J, Dong J, Ding Y, Zheng J. Role of anterior neck soft tissue quantifications by ultrasound in predicting difficult laryngoscopy. Med Sci Monit. 2014 Nov 18;20:2343-50. doi: 10.12659/MSM.891037.
- Background: PubMed 21707828Adhikari S, Zeger W, Schmier C, Crum T, Craven A, Frrokaj I, Pang H, Shostrom V. Pilot study to determine the utility of point-of-care ultrasound in the assessment of difficult laryngoscopy. Acad Emerg Med. 2011 Jul;18(7):754-8. doi: 10.1111/j.1553-2712.2011.01099.x. Epub 2011 Jun 27.
- Background: PubMed 26948251Pinto J, Cordeiro L, Pereira C, Gama R, Fernandes HL, Assuncao J. Predicting difficult laryngoscopy using ultrasound measurement of distance from skin to epiglottis. J Crit Care. 2016 Jun;33:26-31. doi: 10.1016/j.jcrc.2016.01.029. Epub 2016 Feb 11.
- Background: PubMed 34914641Carsetti A, Sorbello M, Adrario E, Donati A, Falcetta S. Airway Ultrasound as Predictor of Difficult Direct Laryngoscopy: A Systematic Review and Meta-analysis. Anesth Analg. 2022 Apr 1;134(4):740-750. doi: 10.1213/ANE.0000000000005839.
- Background: PubMed 39099593Fernandez-Vaquero MA, De Luis-Cabezon N, Garcia-Aroca MA, Alvarez-Avello JM, Vives-Santacana M, Greif R, Martinez-Hurtado ED, Ly-Liu D. Pilot multicenter study to determine the utility of point-of-care ultrasound to predict difficulty of tracheal intubation using videolaryngoscopy with the McGrath Mac videolaryngoscope. Front Med (Lausanne). 2024 Jul 19;11:1406676. doi: 10.3389/fmed.2024.1406676. eCollection 2024.
- Background: PubMed 9754506Levitan RM, Ochroch EA, Kush S, Shofer FS, Hollander JE. Assessment of airway visualization: validation of the percentage of glottic opening (POGO) scale. Acad Emerg Med. 1998 Sep;5(9):919-23. doi: 10.1111/j.1553-2712.1998.tb02823.x.
- Background: PubMed 27130327Lee JH, Turner DA, Kamat P, Nett S, Shults J, Nadkarni VM, Nishisaki A; Pediatric Acute Lung Injury and Sepsis Investigators (PALISI); National Emergency Airway Registry for Children (NEAR4KIDS). The number of tracheal intubation attempts matters! A prospective multi-institutional pediatric observational study. BMC Pediatr. 2016 Apr 29;16:58. doi: 10.1186/s12887-016-0593-y.
- Individual participant dataSharing planned: No
Related trials for Neonates
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
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.
Elizabeth M O'Brien, MD, MAS principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonates and Infants Aged 0 Days to 12 Months Scheduled for Elective Surgery, run by Children's Hospital of Philadelphia 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 8 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 4 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of Glottic Opening (POGO) score (time frame: From enrollment to the end of successful tracheal intubation, approximately 30 minutes.). 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 NCT07444528, which also lists 23 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 Mar 2026.