Pyloric StenosisNCT02775214
Conventional Direct Laryngoscopy Vs. Video Laryngoscopy With The C-MAC For Pyloromyotomy
A study testing Video Laryngoscopy in people with Pyloric Stenosis and Intubation, Pediatric, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to compare two different ways of placing breathing tubes for surgery. Both ways are used currently to place breathing tubes and are safe and effective. This study seeks to determine if one way is better than the other for infants with pyloric stenosis. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Pyloric Stenosis, Intubation, Pediatric
- What is being tested?
- Video Laryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to 12 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Need general anesthesia for pyloromyotomy procedure
- Have been informed of the nature of the study and informed consent has been obtained from the legally responsible guardian
Who cannot join
- Abnormal/difficult airway
- Allergy to succinylcholine and/or propofol
Trial locations and contacts
1 site in 1 country.
United States1 site
Riley Hospital for Children at IU Health
Indianapolis, Indiana, 46202
About this study
The purpose of this study is to compare two different ways of placing breathing tubes for surgery. Both ways are used currently to place breathing tubes and are safe and effective. This study seeks to determine if one way is better than the other for infants with pyloric stenosis.
Read the detailed description
Specific aims of this study include determining if there is a difference in the desaturation rates of the two different intubation techniques- Direct Laryngoscopy and the C-MAC video laryngoscope. Also is there a difference in intubation success between the two techniques, does intubation success vary with different training levels, and does desaturation rate differ among training levels.
- Conditions
- Pyloric Stenosis, Intubation, Pediatric
- Being tested
- Video Laryngoscopy
- Keywords
- Storz C-MAC, direct laryngoscopy, pyloromyotomy, rapid sequence
- Medical subject headings
- Pyloric Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video LaryngoscopyDevice
Also called C-MAC
| Study group | Role | What they receive |
|---|---|---|
| Conventional Direct Laryngoscopy | No intervention | Endotracheal intubation will be performed by conventional direct laryngoscopy. |
| Video Laryngoscopy | Active comparator | Endotracheal intubation will be performed by video laryngoscopy with the C-MAC. Receives: Device: Video Laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Had Desaturation Below 80% During Intubation
Patient had a desaturation below 80% during intubation with either conventional laryngoscope or video laryngoscope
Measured: During intubation attempt (less than two minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startSep 2013
- Primary completion12 Jul 2022
- Study completion12 Jul 2022
Why it stopped: Change in staffing structure, no longer fit original study design
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pyloric StenosisStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicole Horn, Indiana University
- Investigators
- Nicole Horn, MD, Principal investigator, Sponsor-Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775214
- Sponsor's protocol ID
- 1306011553
- Status last verified
- Oct 2023
- First submitted
- 13 May 2016
- Last updated
- 1 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Direct Laryngoscopy Vs. Video Laryngoscopy With The C-MAC For Pyloromyotomy
- ClinicalTrials.gov ID
- NCT02775214
- Acronym / sponsor ID
- 1306011553
- Conditions
- Pyloric Stenosis, Intubation, Pediatric
- Keywords
- Storz C-MAC, direct laryngoscopy, pyloromyotomy, rapid sequence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in staffing structure, no longer fit original study design
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 17 May 2016 (estimated)
- Results
- Posted 1 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare two different ways of placing breathing tubes for surgery. Both ways are used currently to place breathing tubes and are safe and effective. This study seeks to determine if one way is better than the other for infants with pyloric stenosis.
Detailed description
Specific aims of this study include determining if there is a difference in the desaturation rates of the two different intubation techniques- Direct Laryngoscopy and the C-MAC video laryngoscope. Also is there a difference in intubation success between the two techniques, does intubation success vary with different training levels, and does desaturation rate differ among training levels.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Direct Laryngoscopy | No intervention | –Endotracheal intubation will be performed by conventional direct laryngoscopy. |
| Video Laryngoscopy | Active comparator | Device: Video LaryngoscopyEndotracheal intubation will be performed by video laryngoscopy with the C-MAC. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Need general anesthesia for pyloromyotomy procedure
- Have been informed of the nature of the study and informed consent has been obtained from the legally responsible guardian
Key exclusion criteria (2 listed)
- Abnormal/difficult airway
- Allergy to succinylcholine and/or propofol
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 |
|---|---|---|
| Video LaryngoscopyAlso: C-MAC | Device | Video Laryngoscopy |
Primary outcome
Number of Participants Who Had Desaturation Below 80% During Intubation
Time frame: During intubation attempt (less than two minutes)
Patient had a desaturation below 80% during intubation with either conventional laryngoscope or video laryngoscope
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Pyloric Stenosis
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Active, not recruitingPhase 3
Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy
Melanoma, Ovarian Cancer
Recruiting
Testing an Enhanced Digital Delivery Model for Inherited Cancer Genetic Testing in Young Adults With Cancer
Miscellaneous Neoplasm, Nos, Non-Neoplastic Condition, Nos
RecruitingEarly Phase 1
Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation
CNS Embryonal Tumor, CNS, Medulloblastoma
Not yet recruiting
Prophylactic PPI Use After EUS-GE Procedure
Malignant Gastric Outlet Obstruction
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.
Nicole Horn, MD principal investigator
Sponsor-Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Laryngoscopy in people with Pyloric Stenosis and Intubation, Pediatric, run by Indiana University 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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 1 Nov 2023. 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?
Yes. Results are posted in the registry (first posted 1 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Had Desaturation Below 80% During Intubation (time frame: During intubation attempt (less than two minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.