AnesthesiaNCT03430908
Blind Gastric Tube Placement: Incidence of Malposition Confirmed by Ultrasonography
An observational study of Anesthesia, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This is a prospective, single-arm cohort, observational study to determine the incidence of gastric tube malposition during blind insertion by an anesthesia provider. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Blind Gastric Tube Placement
- Type of treatment
- Pill or oral medicine
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2017to 17 Jun 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult participants undergoing general anesthesia with an endotracheal tube that will have a gastric tube blindly inserted by an anesthesia provider.
Who may be able to join
- The adult population, ages 18 and greater
- Patients undergoing general anesthesia with an endotracheal tube that will have a gastric tube blindly inserted by an anesthesia provider
Who cannot join
- Pediatric population (<18 years)
- Gastric tube inserted under direct visualizing (the use of a Mac or Miller laryngoscope or any video laryngoscope)
- Inability to visualize gastric tube by ultrasound due to body habitus, analogous anatomy, etc
- Pre-anesthesia insitu gastric tube
- Gastric tube inserted by practitioner other than a member of the anesthesia team
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan - Kettering Cancer Center
New York, New York, 10021
About this study
This is a prospective, single-arm cohort, observational study to determine the incidence of gastric tube malposition during blind insertion by an anesthesia provider.
- Conditions
- Anesthesia
- Being tested
- Blind Gastric Tube Placement
- Keywords
- endotracheal tube, gastric tube, 17-653, Memorial Sloan Kettering Cancer Center
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blind Gastric Tube PlacementOther
The provider will be blinded to the ultrasound imaging throughout the entire insertion. This blind insertion process is the standard of care currently practiced at MSKCC. After the provider verbalizes that they have completed the insertion the investigators will stop the ultrasound imaging and complete the data form. No information will be given to the provider about the location of the gastric tube as to not deviate from the standard of care. The only time that information will be provided to the practitioner inserting the tube will be if the tube is positioned in any of the following positions that are thought to be potentially injurious if unrecognized. These positions include intrapulmonary, cranial, nasal or oral pharyngeal placements and diverticular or hiatal hernia sac coiling and remain unrecognized by the practitioner. These are considered positions that have the potential for injury and therefore will be divulged to prevent ensuing injury.
| Study group | Role | What they receive |
|---|---|---|
| Participants with an endotracheal tube | Participants undergoing general anesthesia with an endotracheal tube will have a gastric tube blindly inserted by an anesthesia provider. Receives: Other: Blind Gastric Tube Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of malposition of blindly placed gastric tubes by anesthesia providers
Measured: Day of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start22 Dec 2017
- Primary completion17 Jun 2019
- Study completion17 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis E Tollinche, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430908
- Sponsor's protocol ID
- 17-653
- Status last verified
- Jun 2019
- First submitted
- 7 Feb 2018
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blind Gastric Tube Placement: Incidence of Malposition Confirmed by Ultrasonography
- ClinicalTrials.gov ID
- NCT03430908
- Acronym / sponsor ID
- 17-653
- Conditions
- Anesthesia
- Keywords
- endotracheal tube, gastric tube, 17-653, Memorial Sloan Kettering Cancer Center
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 22 Dec 2017 (actual)
- Primary completion
- 17 Jun 2019 (actual)
- Study completion
- 17 Jun 2019 (actual)
- First posted
- 13 Feb 2018 (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.
This is a prospective, single-arm cohort, observational study to determine the incidence of gastric tube malposition during blind insertion by an anesthesia provider.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with an endotracheal tube | – | Other: Blind Gastric Tube PlacementParticipants undergoing general anesthesia with an endotracheal tube will have a gastric tube blindly inserted by an anesthesia provider. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants undergoing general anesthesia with an endotracheal tube that will have a gastric tube blindly inserted by an anesthesia provider.
Key inclusion criteria (2 listed)
- The adult population, ages 18 and greater
- Patients undergoing general anesthesia with an endotracheal tube that will have a gastric tube blindly inserted by an anesthesia provider
Key exclusion criteria (5 listed)
- Pediatric population (<18 years)
- Gastric tube inserted under direct visualizing (the use of a Mac or Miller laryngoscope or any video laryngoscope)
- Inability to visualize gastric tube by ultrasound due to body habitus, analogous anatomy, etc
- Pre-anesthesia insitu gastric tube
- Gastric tube inserted by practitioner other than a member of the anesthesia team
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 |
|---|---|---|
| Blind Gastric Tube PlacementThe provider will be blinded to the ultrasound imaging throughout the entire insertion. This blind insertion process is the standard of care currently practiced at MSKCC. After the provider verbalizes that they have completed the insertion the investigators will stop the ultrasound imaging and complete the data form. No information will be given to the provider about the location of the gastric tube as to not deviate from the standard of care. The only time that information will be provided to the practitioner inserting the tube will be if the tube is positioned in any of the following positions that are thought to be potentially injurious if unrecognized. These positions include intrapulmonary, cranial, nasal or oral pharyngeal placements and diverticular or hiatal hernia sac coiling and remain unrecognized by the practitioner. These are considered positions that have the potential for injury and therefore will be divulged to prevent ensuing injury. | Other | Participants with an endotracheal tube |
Primary outcome
Incidence of malposition of blindly placed gastric tubes by anesthesia providers
Time frame: Day of procedure
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 18 Jun 2019.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Luis E Tollinche, MD principal investigator
Memorial Sloan Kettering Cancer Center
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 Anesthesia, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 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 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of malposition of blindly placed gastric tubes by anesthesia providers (time frame: Day of procedure). 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 18 Jun 2019.