UnconsciousnessNGNCT03699306
Comparison of Three Methods for NG Tube Placement
A study testing NG tube insertion method in people with Unconsciousness, run by Isfahan University of Medical Sciences at 2 sites in Iran.
Trial summary
Background and Aim: Tubular feeding is used, in patients who cannot take food through their mouths, but the digestive system has the ability to digest food. This method is safe and affordable for the patient and results in maintaining the function of the digestive system and reducing the risk of infection and sepsis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Unconsciousness
- What is being tested?
- NG tube insertion method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesIran
- Study dates
- 21 Jan 2017to 10 Aug 2018
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all intubated patients, referred to the emergency department
Who cannot join
- the presence of symptoms of skull base fracture,
- bleeding disorders and coagulopathies,
- maxillofacial trauma, which led to deformity and impairment of NG tube,
- upper respiratory tract diseases and anomalies,
- nasal congestion and nostril stenosis,
- esophageal disorder (esophageal stenosis and esophageal varicose vein),
- and a history of head and neck radiotherapy.
- Patients who had been intubated in other centers and being referred to these two centers were also excluded.
Trial locations and contacts
2 sites in 1 country.
Iran2 sites
Al-Zahra University Hospital
Isfahan, 8138938728
Mehdi Nasr Isfahani
Isfahan, 8194856781
About this study
Official title: Comparison of Three Methods for NG Tube Placement in Intubated Patients in the Emergency Department During 2016-2018
Background and Aim: Tubular feeding is used, in patients who cannot take food through their mouths, but the digestive system has the ability to digest food. This method is safe and affordable for the patient and results in maintaining the function of the digestive system and reducing the risk of infection and sepsis. The purpose of this study was to compare the three methods of the NG tube placement in intubated patients in the emergency department of university-affiliated hospitals of Isfahan from2016 to 2018.
Materials and Methods: This study was a randomized and prospective clinical trial. The statistical population of this study was all patients who had been referred to the emergency department of Al-Zahra and Ayatollah Kashani hospitals in Isfahan between2016and2018. The sample size was 25 in each group, and in total 75 subjects. The first group was NG tube insertion by the conventional method, the second group was using brake cable and the third group was embeddedby highwayman's hitch or draw hitch, using a silk thread. For all patients, demographic characteristics and possible complications were recorded. Finally, the data were analyzed using SPSS20 software at two statistical levels of descriptive and inferential.
- Conditions
- Unconsciousness
- Being tested
- NG tube insertion method
- Medical subject headings
- Unconsciousness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NG tube insertion methodProcedure or surgery
Also called NG tube placement technique
a feeding tube called naso-gastric or NG tube were inserted through nostril inside the stomach randomly by one of three methods mentioned earlier
| Study group | Role | What they receive |
|---|---|---|
| Conventional r blinded | Active comparator | the participants were allocated to have NG tube inserted in a conventional or blind method. Receives: Procedure: NG tube insertion method |
| Brake cable | Active comparator | the participants were assigned to have NG tube inserted by use of a bike brake cable as a guide wire. Receives: Procedure: NG tube insertion method |
| High way man's hitch | Active comparator | they were selected to have NG tube inserted by use of silk thread knot. Receives: Procedure: NG tube insertion method |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate
success rate was defined as successfully inserted NG tube inside the stomach
Measured: Intraoperative (time from entry of the NG tube through nostril til entering inside the stomach or whenever the operator declared.)
Secondary outcomes (1)
procedure duration
it was measured as the total time from start of the procedure til the entry of the tube inside the stomach.
Measured: Intraoperative (from nostril entry til sromach entry or operatoe declaration as the end of procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start21 Jan 2017
- Primary completion15 Apr 2017
- Study completion10 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UnconsciousnessStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehdi Nasr Isfahani, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699306
- Sponsor's protocol ID
- 396780
- Acronym
- NG
- Status last verified
- Oct 2018
- First submitted
- 1 Oct 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Methods for NG Tube Placement in Intubated Patients in the Emergency Department During 2016-2018
- ClinicalTrials.gov ID
- NCT03699306
- Acronym / sponsor ID
- NG / 396780
- Conditions
- Unconsciousness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- 21 Jan 2017 (actual)
- Primary completion
- 15 Apr 2017 (actual)
- Study completion
- 10 Aug 2018 (actual)
- First posted
- 9 Oct 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.
Background and Aim: Tubular feeding is used, in patients who cannot take food through their mouths, but the digestive system has the ability to digest food. This method is safe and affordable for the patient and results in maintaining the function of the digestive system and reducing the risk of infection and sepsis. The purpose of this study was to compare the three methods of the NG tube placement in intubated patients in the emergency department of university-affiliated hospitals of Isfahan from2016 to 2018.
Materials and Methods: This study was a randomized and prospective clinical trial. The statistical population of this study was all patients who had been referred to the emergency department of Al-Zahra and Ayatollah Kashani hospitals in Isfahan between2016and2018. The sample size was 25 in each group, and in total 75 subjects. The first group was NG tube insertion by the conventional method, the second group was using brake cable and the third group was embeddedby highwayman's hitch or draw hitch, using a silk thread. For all patients, demographic characteristics and possible complications were recorded. Finally, the data were analyzed using SPSS20 software at two statistical levels of descriptive and inferential.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional r blinded | Active comparator | Procedure: NG tube insertion methodthe participants were allocated to have NG tube inserted in a conventional or blind method. |
| Brake cable | Active comparator | Procedure: NG tube insertion methodthe participants were assigned to have NG tube inserted by use of a bike brake cable as a guide wire. |
| High way man's hitch | Active comparator | Procedure: NG tube insertion methodthey were selected to have NG tube inserted by use of silk thread knot. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all intubated patients, referred to the emergency department
Key exclusion criteria (8 listed)
- the presence of symptoms of skull base fracture,
- bleeding disorders and coagulopathies,
- maxillofacial trauma, which led to deformity and impairment of NG tube,
- upper respiratory tract diseases and anomalies,
- nasal congestion and nostril stenosis,
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 |
|---|---|---|
| NG tube insertion methodAlso: NG tube placement techniquea feeding tube called naso-gastric or NG tube were inserted through nostril inside the stomach randomly by one of three methods mentioned earlier | Procedure or surgery | Brake cable, Conventional r blinded, High way man's hitch |
Primary outcome
success rate
Time frame: Intraoperative (time from entry of the NG tube through nostril til entering inside the stomach or whenever the operator declared.)
success rate was defined as successfully inserted NG tube inside the stomach
1 secondary outcome
procedure duration
Time frame: Intraoperative (from nostril entry til sromach entry or operatoe declaration as the end 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 9 Oct 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NG tube insertion method in people with Unconsciousness, run by Isfahan University of Medical Sciences at 2 sites in Iran.
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 8 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 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. 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?
success rate (time frame: Intraoperative (time from entry of the NG tube through nostril til entering inside the stomach or whenever the operator declared.)). 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 9 Oct 2018.