Elective Surgery of Gastrointestinal TractNCT01783366
Nasogastric Tube Insertion Using Cook Airway Exchange Catheter in Anesthetized Patients
A study testing TUBE EXCHANGER in people with Elective Surgery of Gastrointestinal Tract and 100 Adults Aged Between 20 and 70 Years Old, run by Pusan National University Hospital at 1 site in South Korea.
Trial summary
we first examined whether use of tube exchange catheter during NGT insertion could increase the success rate on the first attempt of NGT insertion compared with conventional technique. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Elective Surgery of Gastrointestinal Tract, 100 Adults Aged Between 20 and 70 Years Old, ASA Physical Status of I or II
- What is being tested?
- TUBE EXCHANGER
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2013to Feb 2014
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status of I or II who were scheduled to undergo elective surgery of gastrointestinal tract with NGT insertion under general anesthesia were enrolled
Who cannot join
- Patients with maxillofacial trauma, inability to adequately protect airway, and esophageal abnormalities were excluded. Pregnant patients were also excluded from the study.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Pnuyh Anesthesia
Yangsan
JI WOOK YOON, PhD
About this study
we first examined whether use of tube exchange catheter during NGT insertion could increase the success rate on the first attempt of NGT insertion compared with conventional technique. We then addressed the question of whether the use of tube exchange catheter might decrease the possible occurrence of complication associated with YOON insertion.
- Conditions
- Elective Surgery of Gastrointestinal Tract, 100 Adults Aged Between 20 and 70 Years Old, ASA Physical Status of I or II
- Being tested
- TUBE EXCHANGER
- Keywords
- nasogastric tube, tube exchange catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TUBE EXCHANGERDevice
Also called TUBE EXCHANGER USAGE
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | No intervention | In the control group (Group A) inserting the lubricated NG tube through the nostril, at that time head maintained in the neutral position. |
| tube-exchanger | Active comparator | The tube-exchanger group (Group B) made use of tube-exchanger G36402 (CAEC, [cook medical, Bloomington, IN]) as a stylet that was lubricated and inserted within 20-F NGT until the tip of the tube-exchanger was at the tip of the NGT Receives: Device: TUBE EXCHANGER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of attempt of NGT insertion
After anesthetic induction, in the control group inserting the lubricated NG tube through the nostril, at that time head maintained in the neutral position. The tube-exchanger group made use of tube-exchanger as stylet within 20-F NGT. Success of appropriate NGT insertion through the nostrils until 70cm of NGT was considered with gurgling sounds on the auscultation over the epigastrium when 10ml of air was injected through the NGT and gastric contents aspiration via NGT. Total number of attempts until successful NGT insertion was recorded and tried at least three times, and was considered to have failed.
Thus, procedure time would be the dependent factor of primary endpoin which could increse the success rate of NGT.
Measured: after successful insertion of NGT, within 1 hr
Procedure time of NGT insertion
After anesthetic induction, in the control group inserting the lubricated NG tube through the nostril, at that time head maintained in the neutral position. The tube-exchanger group made use of tube-exchanger as stylet within 20-F NGT. Success of appropriate NGT insertion was considered with gurgling sounds on the auscultation over the epigastrium when 10ml of air was injected through the NGT and gastric contents aspiration via NGT. NGT insertion time recorded when the NGT begun to insert gently through the nostrils until 70cm of NGT.
Measured: after successful insertion of NGT, within 1 hr
Secondary outcomes (1)
presence of bleeding of the larynx, and knotting or kinking of NGT under laryngoscopic view
The investigators examined the occurrence of complication associated with NGT insertion. After successful NGT insertion, we recorded presence of bleeding of the larynx, and knotting or kinking of NGT using laryngoscopy.
Measured: after successful insertion of NGT within the time of completion of surgery, expected average within 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Surgery of Gastrointestinal TractStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pusan National University Yangsan Hospital
- Responsible party
- Principal investigator, Hyeon-Jeong Lee, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783366
- Sponsor's protocol ID
- PNU03-2013-002
- Other IDs
- PNUYH03-2013-002
- Status last verified
- Feb 2013
- First submitted
- 24 Jan 2013
- Last updated
- 5 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasogastric Tube Insertion Using Cook Airway Exchange Catheter in Anesthetized Patients
- ClinicalTrials.gov ID
- NCT01783366
- Acronym / sponsor ID
- PNU03-2013-002
- Conditions
- Elective Surgery of Gastrointestinal Tract, 100 Adults Aged Between 20 and 70 Years Old, ASA Physical Status of I or II
- Keywords
- nasogastric tube, tube exchange catheter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Collaborators
- Pusan National University Yangsan Hospital
- Study start
- Jan 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 4 Feb 2013 (estimated)
- 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.
we first examined whether use of tube exchange catheter during NGT insertion could increase the success rate on the first attempt of NGT insertion compared with conventional technique. We then addressed the question of whether the use of tube exchange catheter might decrease the possible occurrence of complication associated with YOON insertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL | No intervention | –In the control group (Group A) inserting the lubricated NG tube through the nostril, at that time head maintained in the neutral position. |
| tube-exchanger | Active comparator | Device: TUBE EXCHANGERThe tube-exchanger group (Group B) made use of tube-exchanger G36402 (CAEC, [cook medical, Bloomington, IN]) as a stylet that was lubricated and inserted within 20-F NGT until the tip of the tube-exchanger was at the tip of the NGT |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA physical status of I or II who were scheduled to undergo elective surgery of gastrointestinal tract with NGT insertion under general anesthesia were enrolled
Key exclusion criteria (1 listed)
- Patients with maxillofacial trauma, inability to adequately protect airway, and esophageal abnormalities were excluded. Pregnant patients were also excluded from the study.
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 |
|---|---|---|
| TUBE EXCHANGERAlso: TUBE EXCHANGER USAGE | Device | tube-exchanger |
Primary outcome
Number of attempt of NGT insertion
Time frame: after successful insertion of NGT, within 1 hr
After anesthetic induction, in the control group inserting the lubricated NG tube through the nostril, at that time head maintained in the neutral position. The tube-exchanger group made use of tube-exchanger as stylet within 20-F NGT. Success of appropriate NGT insertion through the nostrils until 70cm of NGT was considered with gurgling sounds on the auscultation over the epigastrium when 10ml of air was injected through the NGT and gastric contents aspiration via NGT. Total number of attempts until successful NGT insertion was recorded and tried at least three times, and was considered to have failed. Thus, procedure time would be the dependent factor of primary endpoin which could increse the success rate of NGT.
Procedure time of NGT insertion
Time frame: after successful insertion of NGT, within 1 hr
After anesthetic induction, in the control group inserting the lubricated NG tube through the nostril, at that time head maintained in the neutral position. The tube-exchanger group made use of tube-exchanger as stylet within 20-F NGT. Success of appropriate NGT insertion was considered with gurgling sounds on the auscultation over the epigastrium when 10ml of air was injected through the NGT and gastric contents aspiration via NGT. NGT insertion time recorded when the NGT begun to insert gently through the nostrils until 70cm of NGT.
1 secondary outcome
presence of bleeding of the larynx, and knotting or kinking of NGT under laryngoscopic view
Time frame: after successful insertion of NGT within the time of completion of surgery, expected average within 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TUBE EXCHANGER in people with Elective Surgery of Gastrointestinal Tract and 100 Adults Aged Between 20 and 70 Years Old, run by Pusan National University Hospital at 1 site in South Korea.
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: status not confirmed, as of the sponsor's last update on 5 Feb 2013. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HYEON-JEONG LEE, PhD (82-10-76807689, lhjksk@pusan.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of attempt of NGT insertion (time frame: after successful insertion of NGT, within 1 hr). The study lists 2 primary outcomes in all. 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 5 Feb 2013.