General AnesthesiaNCT03492008
Comparison of Three Techniques of Nasogastric Tube Insertion Without Instrumentation
A study testing Conventional technique, Contralateral cricothyroid pressure and Ipsilateral head turning in people with General Anesthesia, run by University of Malaya.
Trial summary
This study compares two modified techniques(contralateral cricothyroid pressure and ipsilateral head turning technique) of nasogastric tube insertion in anesthetized and intubated patients with the conventional technique. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Conventional technique, Contralateral cricothyroid pressure and Ipsilateral head turning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2016
- 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
- patient who is scheduled for elective surgery under general anaesthesia requiring NGT insertion
- aged 20 to 70 years old
- with normal airway (Commack Lehane 1 or 2) and neck movements.
Who cannot join
- Patient who has nasal stenosis, nasal septal deviation, upper airway deformity, base of skull fracture, oesophageal disorders, coagulopathy, and pregnant.
About this study
Official title: Comparison of Three Techniques of Nasogastric Tube Insertion Without Instrumentation in Anesthetised Intubated Patients: A Prospective Randomized Controlled Trial
This study compares two modified techniques(contralateral cricothyroid pressure and ipsilateral head turning technique) of nasogastric tube insertion in anesthetized and intubated patients with the conventional technique.
Read the detailed description
The insertion of nasogastric tube in anesthetized, paralysed and intubated unconscious patients may be difficult, with a reported failure rate of nearly 50% on the first attempt, with the head in neutral position there are many different maneuvers to facilitate the insertion of nasogastric tube published.
Our hypothesis is that contralateral cricothyroid pressure to the selected nostril for nasogastric tube insertion will be able to avoid the difficulty.
Therefore we are going to compare this technique with the conventional technique (head in neutral position) with lateral head turning group and contralateral cricothyroid pressure group We hope that the contralateral cricothyroid pressure will increase the success rate, as this will be helpful in intubated patients with neck pathology.
- Conditions
- General Anesthesia
- Being tested
- Conventional technique, Contralateral cricothyroid pressure, Ipsilateral head turning
- Keywords
- nasogastric tube, general anesthesia, head position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional techniqueOther
Nasogastric tube insertion with patient's head in neutral position
Contralateral cricothyroid pressureOther
Cricothyroid pressure is applied externally in the contralateral direction of selected nostril before nasogastric insertion.
Ipsilateral head turningOther
Patient's head is turned to the ipsilateral side of the selected nostril before nasogastric tube insertion.
| Study group | Role | What they receive |
|---|---|---|
| Conventional technique | Active comparator | Nasogastric tube Receives: Other: Conventional technique |
| Contralateral cricothyroid pressure | Experimental | Nasogastric tube Receives: Other: Contralateral cricothyroid pressure |
| Ipsilateral head turning | Experimental | Nasogastric tube Receives: Other: Ipsilateral head turning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall success rate
Percentage
Measured: At induction of general anesthesia
Secondary outcomes (2)
First attempt success rate
Percentage
Measured: At induction of general anesthesia
Time taken to successful nasogastric tube placement
Procedure start time is defined as the time when the nasogastric tube is inserted through the nostril. The procedure end time is defined as the time of successful insertion and confirmed NGT placement or the time after two failed attempts. The outcome is measured in second.
Measured: At induction of general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start1 Jan 2016
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by University of MalayaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sook Hui Chaw, M.Med, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492008
- Sponsor's protocol ID
- 201510-1718
- Status last verified
- Apr 2018
- First submitted
- 2 Apr 2018
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Techniques of Nasogastric Tube Insertion Without Instrumentation in Anesthetised Intubated Patients: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03492008
- Acronym / sponsor ID
- 201510-1718
- Conditions
- General Anesthesia
- Keywords
- nasogastric tube, general anesthesia, head position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 9 Apr 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 study compares two modified techniques(contralateral cricothyroid pressure and ipsilateral head turning technique) of nasogastric tube insertion in anesthetized and intubated patients with the conventional technique.
Detailed description
The insertion of nasogastric tube in anesthetized, paralysed and intubated unconscious patients may be difficult, with a reported failure rate of nearly 50% on the first attempt, with the head in neutral position there are many different maneuvers to facilitate the insertion of nasogastric tube published.
Our hypothesis is that contralateral cricothyroid pressure to the selected nostril for nasogastric tube insertion will be able to avoid the difficulty.
Therefore we are going to compare this technique with the conventional technique (head in neutral position) with lateral head turning group and contralateral cricothyroid pressure group We hope that the contralateral cricothyroid pressure will increase the success rate, as this will be helpful in intubated patients with neck pathology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional technique | Active comparator | Other: Conventional techniqueNasogastric tube |
| Contralateral cricothyroid pressure | Experimental | Other: Contralateral cricothyroid pressureNasogastric tube |
| Ipsilateral head turning | Experimental | Other: Ipsilateral head turningNasogastric tube |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient who is scheduled for elective surgery under general anaesthesia requiring NGT insertion
- aged 20 to 70 years old
- with normal airway (Commack Lehane 1 or 2) and neck movements.
Key exclusion criteria (1 listed)
- Patient who has nasal stenosis, nasal septal deviation, upper airway deformity, base of skull fracture, oesophageal disorders, coagulopathy, and pregnant.
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 |
|---|---|---|
| Conventional techniqueNasogastric tube insertion with patient's head in neutral position | Other | Conventional technique |
| Contralateral cricothyroid pressureCricothyroid pressure is applied externally in the contralateral direction of selected nostril before nasogastric insertion. | Other | Contralateral cricothyroid pressure |
| Ipsilateral head turningPatient's head is turned to the ipsilateral side of the selected nostril before nasogastric tube insertion. | Other | Ipsilateral head turning |
Primary outcome
Overall success rate
Time frame: At induction of general anesthesia
Percentage
2 secondary outcomes
First attempt success rate
Time frame: At induction of general anesthesia
Time taken to successful nasogastric tube placement
Time frame: At induction of general anesthesia
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 Apr 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.
Sook Hui Chaw, M.Med principal investigator
University of Malaya
Questions about this trial
What is this clinical trial studying?
A study testing Conventional technique, Contralateral cricothyroid pressure and Ipsilateral head turning in people with General Anesthesia, run by University of Malaya.
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 3 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: finished, as of the sponsor's last update on 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Overall success rate (time frame: At induction of general anesthesia). 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 Apr 2018.