Intubation, IntratrachealPANDANCT07351227
Pediatric Airway: Noninferiority Trial of Devices for Intubation Assessment
A study testing Intubation in people with Intubation, Intratracheal and Airway Management, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The goal of this clinical trial is to find out whether the BESDATA BD-DF videolaryngoscope works as well as the McGRATH™ MAC videolaryngoscope for placing a breathing tube in infants during surgery. The study will also compare the costs associated with using each device. Read more about this study
- Who is it for?
- Ages 6 months to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation, Intratracheal, Airway Management, Video Laryngoscope
- What is being tested?
- Intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2026to 31 Dec 2027
- Phase
- Interventional
- 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 6 months to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The study will include children aged between 6 months and 3 years who are scheduled for elective surgery under general anesthesia at the Children's Institute (Instituto da Criança - ICr) of the Hospital das Clínicas Complex, University of São Paulo Medical School (HC-FMUSP), provided that informed consent is obtained from their parents or legal guardians.
Who cannot join
- Patients under one year of age will be excluded if informed consent is not obtained from their legal guardians, if they are classified as ASA physical status IV or higher, present with hemodynamic instability, or have craniofacial abnormalities or oral deformities suggestive of a potentially difficult airway.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Instituto da Criança e do Adolescente, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo
São Paulo, São Paulo, 05403-000
Vinicius C Quintão, MD, PhD, 5511971273950, vinicius.quintao@hc.fm.usp.br
Lucas F Pereira
About this study
Official title: Comparison of the Effectiveness and Cost-Effectiveness of McGRATH™ MAC and Besdata Videolaryngoscopes in the Orotracheal Intubation of Children: A Non-Inferiority Randomized Clinical Trial
The goal of this clinical trial is to find out whether the BESDATA BD-DF videolaryngoscope works as well as the McGRATH™ MAC videolaryngoscope for placing a breathing tube in infants during surgery. The study will also compare the costs associated with using each device.
The main questions this study aims to answer are:
Read more
Is the BESDATA BD-DF videolaryngoscope as effective as the McGRATH™ MAC videolaryngoscope for successful placement of a breathing tube on the first attempt in infants?
Are there differences between the two devices in terms of procedure time, number of attempts, airway-related complications, and overall costs?
Researchers will compare infants who are intubated using the BESDATA BD-DF videolaryngoscope with infants who are intubated using the McGRATH™ MAC videolaryngoscope to see whether the two devices perform similarly and whether one is more cost-effective than the other.
Participants will:
Be randomly assigned to have a breathing tube placed using one of the two videolaryngoscopes;
Receive standard general anesthesia for an elective surgical procedure;
Have information collected during and after the procedure to assess safety, effectiveness, and costs.
Read the detailed description
Airway management in infants and young children is technically challenging and carries a higher risk of complications than in older pediatric or adult patients. Achieving successful orotracheal intubation on the first attempt is particularly important in this population due to limited oxygen reserves and increased vulnerability to hypoxia, airway trauma, and hemodynamic instability. Videolaryngoscopy has been introduced as an alternative to conventional direct laryngoscopy with the potential to improve glottic visualization and intubation success. However, evidence comparing different videolaryngoscopy devices in infants remains limited, and there is currently no consensus regarding the optimal device for this age group.
Although several videolaryngoscopes are available on the market, most comparative studies have focused on adult populations. In pediatrics, and especially in infants under one year of age, published data are scarce. The McGRATH™ MAC videolaryngoscope has been more extensively studied and is widely used in clinical practice. In contrast, the BESDATA BD-DF videolaryngoscope is a newer device with very limited clinical evidence, and no head-to-head trials have compared it with other videolaryngoscopes in children. Furthermore, despite the increasing adoption of videolaryngoscopy, the economic impact of using different devices has not been adequately investigated in pediatric settings.
This study is designed to address these gaps by comparing the clinical performance and cost-effectiveness of the BESDATA BD-DF and McGRATH™ MAC videolaryngoscopes in infants undergoing elective surgery under general anesthesia. The trial will evaluate whether the BESDATA device is non-inferior to the McGRATH device in terms of intubation effectiveness while also assessing relevant economic outcomes associated with each technology.
The study will be conducted as a prospective, randomized, double-blind clinical trial at a tertiary pediatric center. Participants will be randomly allocated to undergo tracheal intubation with one of the two videolaryngoscopes. All procedures will be performed by trained anesthesiologists experienced with both devices, and data will be collected using a standardized protocol in a secure electronic database.
In addition to comparing clinical performance, the study will include an economic evaluation that considers the costs of device acquisition, required consumables, and expenses related to potential postoperative complications associated with airway management. This integrated approach aims to provide clinically meaningful and economically relevant information to support evidence-based decision-making in pediatric anesthesia.
By directly comparing two videolaryngoscopy systems in a randomized design, this trial seeks to generate high-quality evidence regarding the most effective and sustainable option for airway management in infants. The results are expected to inform clinical practice, guide resource allocation, and contribute to safer perioperative care for pediatric patients.
- Being tested
- Intubation
- Keywords
- Videolaryngoscope, Pediatric orotracheal intubation, Cost effectiveness, McGrath MAC, BESDATA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntubationDevice
Intubation of pediatric patients under one year of age undergoing elective surgery under general anesthesia requiring orotracheal intubation, with one or another videolaryngoscope device.
| Study group | Role | What they receive |
|---|---|---|
| McGrath MAC | Active comparator | Intubation the included participants with the McGrath MAC videolaryngoscope Receives: Device: Intubation |
| BESDATA BD-DF | Experimental | Intubation the included participants with the BESDATA BD-DF videolaryngoscope Receives: Device: Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
First-attempt intubation success
Proportion of participants in whom successful orotracheal intubation is achieved on the first laryngoscopy attempt using the allocated videolaryngoscope, without the need for additional attempts or device change.
Measured: From randomization until up to 15 minutes
Secondary outcomes (1)
Incremental cost-effectiveness ratio of videolaryngoscopes
Cost-effectiveness will be assessed using the Incremental Cost-Effectiveness Ratio (ICER), calculated as the difference in total cost per patient (unit: US dollars) between the BESDATA BD-DF and McGRATH™ MAC devices divided by the difference in effectiveness, defined as the rate of successful first-attempt intubation (unit: percentage). Total costs will include device and consumable expenses and direct hospital costs related to postoperative complications and additional length of stay.
Measured: From the day of surgery until hospital discharge (up to 30 days postoperatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Mar 2026
- Primary completion31 Aug 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 (5)Papers the sponsor has linked to this study.
- Other trials for Intubation, IntratrachealStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, double-blind clinical trial designed to evaluate the cost-effectiveness and clinical outcomes of the BESDATA BD-DF and McGrath™ MAC videolaryngoscopes in pediatric patients under one year of age undergoing elective surgery under general anesthesia requiring orotracheal intubation. Inclusion criteria The study will include children aged between 6 months and 3 years who are scheduled for elective surgery under general anesthesia at the Children's Institute (Instituto da Criança - ICr) of the Hospital das Clínicas Complex, University of São Paulo Medical School (HC-FMUSP), provided that informed consent is obtained from their parents or legal guardians. Exclusion criteria Patients under one year of age will be excluded if informed consent is not obtained from their legal guardians, if they are classified as ASA physical status IV or higher, present with hemodynamic instability, or have craniofacial abnormalities or oral deformities suggestive of a po
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vinícius C Quintão, MD, MSc, PhD, University of Sao Paulo General Hospital
- Investigators
- Vinícius C Quintão, MD, PhD, Principal investigator, Hospital das Clínicas HCFMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351227
- Sponsor's protocol ID
- PANDA
- Acronym
- PANDA
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No, individual participant data will not be shared.
Publications
Gupta A, Sharma R, Gupta N. Evolution of videolaryngoscopy in pediatric population. J Anaesthesiol Clin Pharmacol. 2021 Jan-Mar;37(1):14-27. doi: 10.4103/joacp.JOACP_7_19. Epub 2021 Apr 10.
PubMed 34103817Fiadjoe 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 26705976Hu X, Jin Y, Li J, Xin J, Yang Z. Efficacy and safety of videolaryngoscopy versus direct laryngoscopy in paediatric intubation: A meta-analysis of 27 randomized controlled trials. J Clin Anesth. 2020 Nov;66:109968. doi: 10.1016/j.jclinane.2020.109968. Epub 2020 Jul 6.
PubMed 32645564Abbas A, Samad L. Children at the heart of global surgery: children's surgery in low- and middle-income countries. J Public Health Emerg 2020;4:34.10.21037/jphe-2020-gs-08
Rabbitts JA, Groenewald CB. Epidemiology of Pediatric Surgery in the United States. Paediatr Anaesth. 2020 Oct;30(10):1083-1090. doi: 10.1111/pan.13993. Epub 2020 Aug 29.
PubMed 32777147
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness and Cost-Effectiveness of McGRATH™ MAC and Besdata Videolaryngoscopes in the Orotracheal Intubation of Children: A Non-Inferiority Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07351227
- Acronym / sponsor ID
- PANDA / PANDA
- Keywords
- Videolaryngoscope, Pediatric orotracheal intubation, Cost effectiveness, McGrath MAC, BESDATA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Jan 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.
The goal of this clinical trial is to find out whether the BESDATA BD-DF videolaryngoscope works as well as the McGRATH™ MAC videolaryngoscope for placing a breathing tube in infants during surgery. The study will also compare the costs associated with using each device.
The main questions this study aims to answer are:
Is the BESDATA BD-DF videolaryngoscope as effective as the McGRATH™ MAC videolaryngoscope for successful placement of a breathing tube on the first attempt in infants?
Are there differences between the two devices in terms of procedure time, number of attempts, airway-related complications, and overall costs?
Researchers will compare infants who are intubated using the BESDATA BD-DF videolaryngoscope with infants who are intubated using the McGRATH™ MAC videolaryngoscope to see whether the two devices perform similarly and whether one is more cost-effective than the other.
Participants will:
Be randomly assigned to have a breathing tube placed using one of the two videolaryngoscopes;
Receive standard general anesthesia for an elective surgical procedure;
Have information collected during and after the procedure to assess safety, effectiveness, and costs.
Detailed description
Airway management in infants and young children is technically challenging and carries a higher risk of complications than in older pediatric or adult patients. Achieving successful orotracheal intubation on the first attempt is particularly important in this population due to limited oxygen reserves and increased vulnerability to hypoxia, airway trauma, and hemodynamic instability. Videolaryngoscopy has been introduced as an alternative to conventional direct laryngoscopy with the potential to improve glottic visualization and intubation success. However, evidence comparing different videolaryngoscopy devices in infants remains limited, and there is currently no consensus regarding the optimal device for this age group.
Although several videolaryngoscopes are available on the market, most comparative studies have focused on adult populations. In pediatrics, and especially in infants under one year of age, published data are scarce. The McGRATH™ MAC videolaryngoscope has been more extensively studied and is widely used in clinical practice. In contrast, the BESDATA BD-DF videolaryngoscope is a newer device with very limited clinical evidence, and no head-to-head trials have compared it with other videolaryngoscopes in children. Furthermore, despite the increasing adoption of videolaryngoscopy, the economic impact of using different devices has not been adequately investigated in pediatric settings.
This study is designed to address these gaps by comparing the clinical performance and cost-effectiveness of the BESDATA BD-DF and McGRATH™ MAC videolaryngoscopes in infants undergoing elective surgery under general anesthesia. The trial will evaluate whether the BESDATA device is non-inferior to the McGRATH device in terms of intubation effectiveness while also assessing relevant economic outcomes associated with each technology.
The study will be conducted as a prospective, randomized, double-blind clinical trial at a tertiary pediatric center. Participants will be randomly allocated to undergo tracheal intubation with one of the two videolaryngoscopes. All procedures will be performed by trained anesthesiologists experienced with both devices, and data will be collected using a standardized protocol in a secure electronic database.
In addition to comparing clinical performance, the study will include an economic evaluation that considers the costs of device acquisition, required consumables, and expenses related to potential postoperative complications associated with airway management. This integrated approach aims to provide clinically meaningful and economically relevant information to support evidence-based decision-making in pediatric anesthesia.
By directly comparing two videolaryngoscopy systems in a randomized design, this trial seeks to generate high-quality evidence regarding the most effective and sustainable option for airway management in infants. The results are expected to inform clinical practice, guide resource allocation, and contribute to safer perioperative care for pediatric patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, double-blind clinical trial designed to evaluate the cost-effectiveness and clinical outcomes of the BESDATA BD-DF and McGrath™ MAC videolaryngoscopes in pediatric patients under one year of age undergoing elective surgery under general anesthesia requiring orotracheal intubation. Inclusion criteria The study will include children aged between 6 months and 3 years who are scheduled for elective surgery under general anesthesia at the Children's Institute (Instituto da Criança - ICr) of the Hospital das Clínicas Complex, University of São Paulo Medical School (HC-FMUSP), provided that informed consent is obtained from their parents or legal guardians. Exclusion criteria Patients under one year of age will be excluded if informed consent is not obtained from their legal guardians, if they are classified as ASA physical status IV or higher, present with hemodynamic instability, or have craniofacial abnormalities or oral deformities suggestive of a po
| Arm | Type | Receives |
|---|---|---|
| McGrath MAC | Active comparator | Device: IntubationIntubation the included participants with the McGrath MAC videolaryngoscope |
| BESDATA BD-DF | Experimental | Device: IntubationIntubation the included participants with the BESDATA BD-DF videolaryngoscope |
Who may qualify
- Ages
- 6 months to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The study will include children aged between 6 months and 3 years who are scheduled for elective surgery under general anesthesia at the Children's Institute (Instituto da Criança - ICr) of the Hospital das Clínicas Complex, University of São Paulo Medical School (HC-FMUSP), provided that informed consent is obtained from their parents or legal guardians.
Key exclusion criteria (1 listed)
- Patients under one year of age will be excluded if informed consent is not obtained from their legal guardians, if they are classified as ASA physical status IV or higher, present with hemodynamic instability, or have craniofacial abnormalities or oral deformities suggestive of a potentially difficult airway.
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 |
|---|---|---|
| IntubationIntubation of pediatric patients under one year of age undergoing elective surgery under general anesthesia requiring orotracheal intubation, with one or another videolaryngoscope device. | Device | BESDATA BD-DF, McGrath MAC |
Primary outcome
First-attempt intubation success
Time frame: From randomization until up to 15 minutes
Proportion of participants in whom successful orotracheal intubation is achieved on the first laryngoscopy attempt using the allocated videolaryngoscope, without the need for additional attempts or device change.
1 secondary outcome
Incremental cost-effectiveness ratio of videolaryngoscopes
Time frame: From the day of surgery until hospital discharge (up to 30 days postoperatively)
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 20 Mar 2026.
- Background: PubMed 34103817Gupta A, Sharma R, Gupta N. Evolution of videolaryngoscopy in pediatric population. J Anaesthesiol Clin Pharmacol. 2021 Jan-Mar;37(1):14-27. doi: 10.4103/joacp.JOACP_7_19. Epub 2021 Apr 10.
- 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 32645564Hu X, Jin Y, Li J, Xin J, Yang Z. Efficacy and safety of videolaryngoscopy versus direct laryngoscopy in paediatric intubation: A meta-analysis of 27 randomized controlled trials. J Clin Anesth. 2020 Nov;66:109968. doi: 10.1016/j.jclinane.2020.109968. Epub 2020 Jul 6.
- BackgroundAbbas A, Samad L. Children at the heart of global surgery: children's surgery in low- and middle-income countries. J Public Health Emerg 2020;4:34.10.21037/jphe-2020-gs-08
- Background: PubMed 32777147Rabbitts JA, Groenewald CB. Epidemiology of Pediatric Surgery in the United States. Paediatr Anaesth. 2020 Oct;30(10):1083-1090. doi: 10.1111/pan.13993. Epub 2020 Aug 29.
- Individual participant dataSharing planned: No. No, individual participant data will not be shared.
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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.
Vinícius C Quintão, MD, PhD principal investigator
Hospital das Clínicas HCFMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intubation in people with Intubation, Intratracheal and Airway Management, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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: looking for participants now, as of the sponsor's last update on 20 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 Brazil. 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?
Contact Vinícius C Quintão, MD, PhD (5511971273950, vinicius.quintao@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First-attempt intubation success (time frame: From randomization until up to 15 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 NCT07351227, which also lists 5 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 20 Mar 2026.