Intubation ComplicationNasoVISINCT05433155
Nasotracheal Intubation With VL vs DL in Infants Trial
A study testing Nasotracheal intubation in people with Intubation Complication and Intubation; Difficult or Failed, run by Children's Hospital of Philadelphia at 8 sites in United States.
Trial summary
Nasotracheal Intubation with Videolaryngoscopy versus Direct Laryngoscopy in Infants (NasoVISI) Trial is a prospective randomized multicenter study. The study will be conducted at 8 centers in the United States. Read more about this study
- Who is it for?
- Ages 1 day to 365 days
- Conditions the study is for
- Intubation Complication, Intubation; Difficult or Failed, Hypoxia
- What is being tested?
- Nasotracheal intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- 8 sitesUnited States
- Study dates
- 6 Jun 2022to 25 Feb 2025
- 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 day to 365 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males or females age 0 -365 days
- Scheduled for elective cardiothoracic surgery or cardiac catheterization procedures lasting longer than 30 minutes under general anesthesia where nasotracheal intubation will be performed by an anesthesiology clinician
- Plan to use a neuromuscular blocking drug prior to intubation as standard of care
- Parental/guardian permission (informed consent)
- For clinician participants:
- Anesthesia attending, anesthesia fellows, anesthesia resident, Anesthesia Assistant (AA) or CRNA
Who cannot join
- Less than 36 weeks gestation
- Less than 2 kg
- History of difficult intubation
- History of abnormal airway
- Predictive of difficult intubation upon physical examination
- Preoperative endotracheal tube or tracheostomy
- Emergency cases
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
University of Texas at Austin Dell Children's Medical Center
Austin, Texas, 78723
Children's Medical Center Dallas
Dallas, Texas, 75235
Texas Children's Hospital
Houston, Texas, 77030
Vanderbilt University Medical Center
Nashville, Tennessee, 37203-6869
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Seattle Children's Hospital
Seattle, Washington, 98105
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Nasotracheal Intubation With Videolaryngoscopy Versus Direct Laryngoscopy in Infants (NasoVISI) Trial
Nasotracheal Intubation with Videolaryngoscopy versus Direct Laryngoscopy in Infants (NasoVISI) Trial is a prospective randomized multicenter study. The study will be conducted at 8 centers in the United States. It is expected that approximately 700 subjects enrolled to product 670 evaluable subjects.The randomization is 1:1 naso tracheal intubation with the Storz C-Mac Video Videolaryngoscopy (VL) or the Standard Direct Laryngoscope (DL). The primary objective is to compare the nasotracheal intubation (NTI) first attempt success rate using VL vs. DL in infants 0-365 days of age presenting for cardiothoracic surgery and cardiac catheterizations.
Read the detailed description
The primary objectives of the study are to compare the nasotracheal intubation (NTI) first attempt success rate using VL vs. DL in infants 0-365 days of age presenting for cardiothoracic surgery and cardiac catheterizations.
Secondary Objectives include the number of attempts for successful intubation; Incidence of failed NTI (conversion to oral intubation); Incidence of failure to intubate with assigned device; Incidence of complications over all attempts including non-severe and severe complications; Incidence of 1st-attempt complications; Need for cricoid pressure or external laryngeal manipulation, need for adjunct- (Magill forceps), rescue of one technique of the other, Percent of glottic opening (POGO) score less than 100%, intubation sequence exceeding 60 seconds and interaction analysis of weight group (i.e. ≤ median weight \& > median weight (kg)), and by clinicians' experience with cardiac anesthesiology (i.e. Permanent full time team members \& rotating team members) on the association between treatment and outcomes
Study Design: this is a prospective, randomized, multi-center parallel group trial
Setting/Participants: This will be a multi-center study. The target population will be infants 0-365 days of age scheduled for elective cardiothoracic surgery or cardiac catheterization requiring general anesthesia with NTI.
Study Interventions and Measures: The study intervention will be a 1:1 randomization to perform tracheal intubation with the Storz C-Mac Video Videolaryngoscopy (VL) or the Standard Direct Laryngoscope (DL).
Main study outcome measures are as follows:
- The first intubation attempt success rate with each device
- The number of attempts for successful intubation with each device
- Complications associated with intubation
- Conditions
- Intubation Complication, Intubation; Difficult or Failed, Hypoxia, Hypoxemia, Anesthesia Intubation Complication, Pediatric HD
- Being tested
- Nasotracheal intubation
- Keywords
- Laryngoscope, Video Laryngoscope, Direct Laryngoscope, Nasotracheal Intubation, First attempt success, Intubation complications, Intubation technical difficulties, Randomization, Multi-center
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasotracheal intubationDevice
Nontracheal intubation using clinical standard videolaryngoscopy or direct laryngoscopy
| Study group | Role | What they receive |
|---|---|---|
| Videolaryngoscopy | Active comparator | Nasotracheal intubation performed with the Storz C-Mac Video Laryngoscope Receives: Device: Nasotracheal intubation |
| Direct Laryngoscopy | Active comparator | Nasotracheal Intubation performed with the standard clinical direct blades Receives: Device: Nasotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
VL first attempt success rate
Direct observation of intubation in the OR and medical record review
Measured: 24 hours
Secondary outcomes (7)
Number of attempts for successful intubation
Direct observation of intubation in the OR and medical record review
Measured: 24 hours
Incidence of failed NTI (conversion to oral intubation)
Direct observation of intubation in the OR and medical record review
Measured: 24 hours
Incidence of failure to intubate with assigned device
Direct observation of intubation in the OR and medical record review
Measured: 24 hours
Incidence of complications over all attempts including non-severe and severe complications
Direct observation of intubation in the OR and medical record review
Measured: 24 hours
Incidence of 1st-attempt complications
Direct observation of intubation in the OR and medical record review
Measured: 24 hours
Incidence of additional techniques
Direct observation of intubation in the OR and medical record review
Measured: 24 hours
Interaction analysis of weight group and by clinicians' experience with cardiac anesthesiology on the association between treatment and outcomes
Direct observation of intubation in the OR and medical record review
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start6 Jun 2022
- Primary completion25 Feb 2025
- Study completion25 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Intubation ComplicationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, multi-center parallel group trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 680 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Colorado, Seattle Children's Hospital, Baylor College of Medicine, Children's Medical Center Dallas, Dell Children's Medical Center of Central Texas, Children's National Research Institute, Vanderbilt University Medical Center
- Responsible party
- Sponsor
- Investigators
- Annery Garcia-Marcinikiewicz, MD, Principal investigator, The Children Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433155
- Sponsor's protocol ID
- 22-019921
- Acronym
- NasoVISI
- Status last verified
- Mar 2025
- First submitted
- 21 Jun 2022
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fiadjoe JE, Nishisaki A, Jagannathan N, Hunyady AI, Greenberg RS, Reynolds PI, Matuszczak ME, Rehman MA, Polaner DM, Szmuk P, Nadkarni VM, McGowan FX Jr, Litman RS, Kovatsis PG. Airway management complications in children with difficult tracheal intubation from the Pediatric Difficult Intubation (PeDI) registry: a prospective cohort analysis. Lancet Respir Med. 2016 Jan;4(1):37-48. doi: 10.1016/S2213-2600(15)00508-1. Epub 2015 Dec 17.
PubMed 26705976Garcia-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 33308472Greene NH, Jooste EH, Thibault DP, Wallace AS, Wang A, Vener DF, Matsouaka RA, Jacobs ML, Jacobs JP, Hill KD, Ames WA. A Study of Practice Behavior for Endotracheal Intubation Site for Children With Congenital Heart Disease Undergoing Surgery: Impact of Endotracheal Intubation Site on Perioperative Outcomes-An Analysis of the Society of Thoracic Surgeons Congenital Cardiac Anesthesia Society Database. Anesth Analg. 2019 Oct;129(4):1061-1068. doi: 10.1213/ANE.0000000000003594.
PubMed 30198928Jiang J, Ma DX, Li B, Wu AS, Xue FS. Videolaryngoscopy versus direct laryngoscopy for nasotracheal intubation: A systematic review and meta-analysis of randomised controlled trials. J Clin Anesth. 2019 Feb;52:6-16. doi: 10.1016/j.jclinane.2018.08.029. Epub 2018 Aug 25.
PubMed 30153543O'Shea JE, Thio M, Kamlin CO, McGrory L, Wong C, John J, Roberts C, Kuschel C, Davis PG. Videolaryngoscopy to Teach Neonatal Intubation: A Randomized Trial. Pediatrics. 2015 Nov;136(5):912-9. doi: 10.1542/peds.2015-1028. Epub 2015 Oct 19.
PubMed 26482669Low D, Healy D, Rasburn N. The use of the BERCI DCI Video Laryngoscope for teaching novices direct laryngoscopy and tracheal intubation. Anaesthesia. 2008 Feb;63(2):195-201. doi: 10.1111/j.1365-2044.2007.05323.x.
PubMed 18211452Herbstreit F, Fassbender P, Haberl H, Kehren C, Peters J. Learning endotracheal intubation using a novel videolaryngoscope improves intubation skills of medical students. Anesth Analg. 2011 Sep;113(3):586-90. doi: 10.1213/ANE.0b013e3182222a66. Epub 2011 Jun 16.
PubMed 21680859Sun H, Liu M, Lin Z, Jiang H, Niu Y, Wang H, Chen S. Comprehensive identification of 125 multifarious constituents in Shuang-huang-lian powder injection by HPLC-DAD-ESI-IT-TOF-MS. J Pharm Biomed Anal. 2015 Nov 10;115:86-106. doi: 10.1016/j.jpba.2015.06.013. Epub 2015 Jun 30.
PubMed 26177215Lingappan K, Arnold JL, Fernandes CJ, Pammi M. Videolaryngoscopy versus direct laryngoscopy for tracheal intubation in neonates. Cochrane Database Syst Rev. 2018 Jun 4;6(6):CD009975. doi: 10.1002/14651858.CD009975.pub3.
PubMed 29862490Goto T, Gibo K, Hagiwara Y, Morita H, Brown DF, Brown CA 3rd, Hasegawa K; Japanese Emergency Medicine Network Investigators. Multiple failed intubation attempts are associated with decreased success rates on the first rescue intubation in the emergency department: a retrospective analysis of multicentre observational data. Scand J Trauma Resusc Emerg Med. 2015 Jan 16;23:5. doi: 10.1186/s13049-014-0085-8.
PubMed 25700237Goto T, Watase H, Morita H, Nagai H, Brown CA 3rd, Brown DF, Hasegawa K; Japanese Emergency Medicine Network Investigators. Repeated attempts at tracheal intubation by a single intubator associated with decreased success rates in emergency departments: an analysis of a multicentre prospective observational study. Emerg Med J. 2015 Oct;32(10):781-6. doi: 10.1136/emermed-2013-203473. Epub 2014 Dec 31.
PubMed 25552546Sakles JC, Chiu S, Mosier J, Walker C, Stolz U. The importance of first pass success when performing orotracheal intubation in the emergency department. Acad Emerg Med. 2013 Jan;20(1):71-8. doi: 10.1111/acem.12055.
PubMed 23574475Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004 Aug;99(2):607-13, table of contents. doi: 10.1213/01.ANE.0000122825.04923.15.
PubMed 15271750Grunwell JR, Kamat PP, Miksa M, Krishna A, Walson K, Simon D, Krawiec C, Breuer R, Lee JH, Gradidge E, Tarquinio K, Shenoi A, Shults J, Nadkarni V, Nishisaki A; National Emergency Airway Registry for Children (NEAR4KIDS) and the Pediatric Acute Lung Injury and Sepsis (PALISI) Network. Trend and Outcomes of Video Laryngoscope Use Across PICUs. Pediatr Crit Care Med. 2017 Aug;18(8):741-749. doi: 10.1097/PCC.0000000000001175.
PubMed 28492404Abdelgadir IS, Phillips RS, Singh D, Moncreiff MP, Lumsden JL. Videolaryngoscopy versus direct laryngoscopy for tracheal intubation in children (excluding neonates). Cochrane Database Syst Rev. 2017 May 24;5(5):CD011413. doi: 10.1002/14651858.CD011413.pub2.
PubMed 28539007
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasotracheal Intubation With Videolaryngoscopy Versus Direct Laryngoscopy in Infants (NasoVISI) Trial
- ClinicalTrials.gov ID
- NCT05433155
- Acronym / sponsor ID
- NasoVISI / 22-019921
- Conditions
- Intubation Complication, Intubation; Difficult or Failed, Hypoxia, Hypoxemia, Anesthesia Intubation Complication, Pediatric HD
- Keywords
- Laryngoscope, Video Laryngoscope, Direct Laryngoscope, Nasotracheal Intubation, First attempt success, Intubation complications, Intubation technical difficulties, Randomization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 680 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Children's Hospital Colorado, Seattle Children's Hospital, Baylor College of Medicine, Children's Medical Center Dallas, Dell Children's Medical Center of Central Texas, Children's National Research Institute, Vanderbilt University Medical Center
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 25 Feb 2025 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 27 Jun 2022 (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.
Nasotracheal Intubation with Videolaryngoscopy versus Direct Laryngoscopy in Infants (NasoVISI) Trial is a prospective randomized multicenter study. The study will be conducted at 8 centers in the United States. It is expected that approximately 700 subjects enrolled to product 670 evaluable subjects.The randomization is 1:1 naso tracheal intubation with the Storz C-Mac Video Videolaryngoscopy (VL) or the Standard Direct Laryngoscope (DL). The primary objective is to compare the nasotracheal intubation (NTI) first attempt success rate using VL vs. DL in infants 0-365 days of age presenting for cardiothoracic surgery and cardiac catheterizations.
Detailed description
The primary objectives of the study are to compare the nasotracheal intubation (NTI) first attempt success rate using VL vs. DL in infants 0-365 days of age presenting for cardiothoracic surgery and cardiac catheterizations.
Secondary Objectives include the number of attempts for successful intubation; Incidence of failed NTI (conversion to oral intubation); Incidence of failure to intubate with assigned device; Incidence of complications over all attempts including non-severe and severe complications; Incidence of 1st-attempt complications; Need for cricoid pressure or external laryngeal manipulation, need for adjunct- (Magill forceps), rescue of one technique of the other, Percent of glottic opening (POGO) score less than 100%, intubation sequence exceeding 60 seconds and interaction analysis of weight group (i.e. ≤ median weight \& > median weight (kg)), and by clinicians' experience with cardiac anesthesiology (i.e. Permanent full time team members \& rotating team members) on the association between treatment and outcomes
Study Design: this is a prospective, randomized, multi-center parallel group trial
Setting/Participants: This will be a multi-center study. The target population will be infants 0-365 days of age scheduled for elective cardiothoracic surgery or cardiac catheterization requiring general anesthesia with NTI.
Study Interventions and Measures: The study intervention will be a 1:1 randomization to perform tracheal intubation with the Storz C-Mac Video Videolaryngoscopy (VL) or the Standard Direct Laryngoscope (DL).
Main study outcome measures are as follows:
- The first intubation attempt success rate with each device
- The number of attempts for successful intubation with each device
- Complications associated with intubation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective, randomized, multi-center parallel group trial
| Arm | Type | Receives |
|---|---|---|
| Videolaryngoscopy | Active comparator | Device: Nasotracheal intubationNasotracheal intubation performed with the Storz C-Mac Video Laryngoscope |
| Direct Laryngoscopy | Active comparator | Device: Nasotracheal intubationNasotracheal Intubation performed with the standard clinical direct blades |
Who may qualify
- Ages
- 1 day to 365 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Males or females age 0 -365 days
- Scheduled for elective cardiothoracic surgery or cardiac catheterization procedures lasting longer than 30 minutes under general anesthesia where nasotracheal intubation will be performed by an anesthesiology clinician
- Plan to use a neuromuscular blocking drug prior to intubation as standard of care
- Parental/guardian permission (informed consent)
- Anesthesia attending, anesthesia fellows, anesthesia resident, Anesthesia Assistant (AA) or CRNA
Key exclusion criteria (7 listed)
- Less than 36 weeks gestation
- Less than 2 kg
- History of difficult intubation
- History of abnormal airway
- Predictive of difficult intubation upon physical examination
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 |
|---|---|---|
| Nasotracheal intubationNontracheal intubation using clinical standard videolaryngoscopy or direct laryngoscopy | Device | Direct Laryngoscopy, Videolaryngoscopy |
Primary outcome
VL first attempt success rate
Time frame: 24 hours
Direct observation of intubation in the OR and medical record review
7 secondary outcomes
Number of attempts for successful intubation
Time frame: 24 hours
Incidence of failed NTI (conversion to oral intubation)
Time frame: 24 hours
Incidence of failure to intubate with assigned device
Time frame: 24 hours
Incidence of complications over all attempts including non-severe and severe complications
Time frame: 24 hours
Incidence of 1st-attempt complications
Time frame: 24 hours
Incidence of additional techniques
Time frame: 24 hours
Interaction analysis of weight group and by clinicians' experience with cardiac anesthesiology on the association between treatment and outcomes
Time frame: 24 hours
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 28 Mar 2025.
- Background: PubMed 26705976Fiadjoe JE, Nishisaki A, Jagannathan N, Hunyady AI, Greenberg RS, Reynolds PI, Matuszczak ME, Rehman MA, Polaner DM, Szmuk P, Nadkarni VM, McGowan FX Jr, Litman RS, Kovatsis PG. Airway management complications in children with difficult tracheal intubation from the Pediatric Difficult Intubation (PeDI) registry: a prospective cohort analysis. Lancet Respir Med. 2016 Jan;4(1):37-48. doi: 10.1016/S2213-2600(15)00508-1. Epub 2015 Dec 17.
- Background: PubMed 33308472Garcia-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.
- Background: PubMed 30198928Greene NH, Jooste EH, Thibault DP, Wallace AS, Wang A, Vener DF, Matsouaka RA, Jacobs ML, Jacobs JP, Hill KD, Ames WA. A Study of Practice Behavior for Endotracheal Intubation Site for Children With Congenital Heart Disease Undergoing Surgery: Impact of Endotracheal Intubation Site on Perioperative Outcomes-An Analysis of the Society of Thoracic Surgeons Congenital Cardiac Anesthesia Society Database. Anesth Analg. 2019 Oct;129(4):1061-1068. doi: 10.1213/ANE.0000000000003594.
- Background: PubMed 30153543Jiang J, Ma DX, Li B, Wu AS, Xue FS. Videolaryngoscopy versus direct laryngoscopy for nasotracheal intubation: A systematic review and meta-analysis of randomised controlled trials. J Clin Anesth. 2019 Feb;52:6-16. doi: 10.1016/j.jclinane.2018.08.029. Epub 2018 Aug 25.
- Background: PubMed 26482669O'Shea JE, Thio M, Kamlin CO, McGrory L, Wong C, John J, Roberts C, Kuschel C, Davis PG. Videolaryngoscopy to Teach Neonatal Intubation: A Randomized Trial. Pediatrics. 2015 Nov;136(5):912-9. doi: 10.1542/peds.2015-1028. Epub 2015 Oct 19.
- Background: PubMed 18211452Low D, Healy D, Rasburn N. The use of the BERCI DCI Video Laryngoscope for teaching novices direct laryngoscopy and tracheal intubation. Anaesthesia. 2008 Feb;63(2):195-201. doi: 10.1111/j.1365-2044.2007.05323.x.
- Background: PubMed 21680859Herbstreit F, Fassbender P, Haberl H, Kehren C, Peters J. Learning endotracheal intubation using a novel videolaryngoscope improves intubation skills of medical students. Anesth Analg. 2011 Sep;113(3):586-90. doi: 10.1213/ANE.0b013e3182222a66. Epub 2011 Jun 16.
- Background: PubMed 26177215Sun H, Liu M, Lin Z, Jiang H, Niu Y, Wang H, Chen S. Comprehensive identification of 125 multifarious constituents in Shuang-huang-lian powder injection by HPLC-DAD-ESI-IT-TOF-MS. J Pharm Biomed Anal. 2015 Nov 10;115:86-106. doi: 10.1016/j.jpba.2015.06.013. Epub 2015 Jun 30.
- Background: PubMed 29862490Lingappan K, Arnold JL, Fernandes CJ, Pammi M. Videolaryngoscopy versus direct laryngoscopy for tracheal intubation in neonates. Cochrane Database Syst Rev. 2018 Jun 4;6(6):CD009975. doi: 10.1002/14651858.CD009975.pub3.
- Background: PubMed 25700237Goto T, Gibo K, Hagiwara Y, Morita H, Brown DF, Brown CA 3rd, Hasegawa K; Japanese Emergency Medicine Network Investigators. Multiple failed intubation attempts are associated with decreased success rates on the first rescue intubation in the emergency department: a retrospective analysis of multicentre observational data. Scand J Trauma Resusc Emerg Med. 2015 Jan 16;23:5. doi: 10.1186/s13049-014-0085-8.
- Background: PubMed 25552546Goto T, Watase H, Morita H, Nagai H, Brown CA 3rd, Brown DF, Hasegawa K; Japanese Emergency Medicine Network Investigators. Repeated attempts at tracheal intubation by a single intubator associated with decreased success rates in emergency departments: an analysis of a multicentre prospective observational study. Emerg Med J. 2015 Oct;32(10):781-6. doi: 10.1136/emermed-2013-203473. Epub 2014 Dec 31.
- Background: PubMed 23574475Sakles JC, Chiu S, Mosier J, Walker C, Stolz U. The importance of first pass success when performing orotracheal intubation in the emergency department. Acad Emerg Med. 2013 Jan;20(1):71-8. doi: 10.1111/acem.12055.
- 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.
Annery Garcia-Marcinikiewicz, MD principal investigator
The Children Hospital of Philadelphia
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasotracheal intubation in people with Intubation Complication and Intubation; Difficult or Failed, run by Children's Hospital of Philadelphia at 8 sites 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 6 inclusion and 7 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 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
VL first attempt success rate (time frame: 24 hours). 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 NCT05433155, which also lists 20 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 28 Mar 2025.