Injury Due to Endoscopic ExaminationNCT01784237
A Novel Anterior Rhinoscopic Scoring Scale to Predict Nasal Insertability Before Transnasal Endoscopy
A study testing anterior meatoscopy and Nasal sniff test in people with Injury Due to Endoscopic Examination and Transnasal Endoscopy Induced Epistaxis, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
A sniff test for nasal patency is a common method before ultrathin transnasal esophago-gastro-duodenoscopy (UT-EGD) to select the right or left nostril for insertion, yet there is no objective method to select an appropriate meatus insertion site (MIS) where tolerance and epistaxis rate can be improved. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Injury Due to Endoscopic Examination, Transnasal Endoscopy Induced Epistaxis, Transnasal Endoscopy Induced Nasal Pain
- What is being tested?
- anterior meatoscopy and Nasal sniff test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2012to Feb 2013
- 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 outpatients with epigastric discomfort (non-ulcer dyspepsia), aged 18-65 years are eligible for this study.
Who cannot join
- Patients who have prior nasal trauma or surgery, recent or present upper gastrointestinal bleeding and coagulopathy are excluded from this study. Patients who are allergic to an anesthetic agent and who have uncontrolled hypertension or coronary artery disease are not recruited. Those who are uncooperative and unable to answer questions are also excluded.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Buddhist Tzu Chi Hospital
Hualien City, Hualien county, 970
Chi-Tan Hu, MD, PhD, +886933995773, chitan.hu@msa.hinet.net
Chi-Tan Hu, MD, PhD
About this study
Official title: Comparison Between an Anterior Rhinoscopic Scoring Scale With the Sniff Test to Predict Nasal Insertability Before Transnasal Endoscopy: A Prospective, Randomized, Controlled Study
A sniff test for nasal patency is a common method before ultrathin transnasal esophago-gastro-duodenoscopy (UT-EGD) to select the right or left nostril for insertion, yet there is no objective method to select an appropriate meatus insertion site (MIS) where tolerance and epistaxis rate can be improved.
The investigators hypothesize that that an objective anterior rhinoscopy (to be more specific, the investigators term it "anterior meatoscopy") method might be more effective than the subjective breathing-in method (sniff test) to select the appropriate meatus insertion site, thus reducing nasal bleeding and nasal discomfort.
Read more
The aim of this study is to evaluate the effectiveness of an endoscopic meatus scoring scale (EMSS) by anterior meatoscopy (AM) to select a MIS on patient tolerance and adverse events during nasal anesthesia and UT-EGD.
The investigators will perform a prospective randomized-controlled trial to compare patient tolerability and adverse events during nasal anesthesia and endoscopy between the AM-selected and self-selected MIS. A total of 233 consecutive patients with epigastric discomfort (symptoms of non-ulcer dyspepsia) will be included in the study in a large tertiary referral hospital in Taiwan.
Read the detailed description
Transnasal esophago-gastro-duodenoscopy (UT-EGD) offers physicians and patients a number of advantages compared with conventional peroral EGD (P-EGD) and has become increasingly popular in clinical practice over the past several years. However, insertion failure varying from 2.3% to 62.7% due to tight nasal vault have been reported. Dumortire reported 17.9 % of patient refused UT-EGD due to nasal pain and epistaxis remains to be a common side effect. Therefore a well performed nasal anesthesia has been regarded as the most important step for UT-EGD.
The concept of endoscopic guidance is actually an application of anterior rhinoscopy to select the most patent meatus for nasal anesthesia and endoscopic insertion. The scope should be placed in the side of the nasal cavity that is most patent. Therefore, it is reasonable that a nasal examination is performed prior to UT-EGD to determine the less obstructed side.
In fact, anterior rhinoscopy is a common outpatient procedure by otolaryngologists and is performed with an otoscope. Instead, we use a transnasal endoscope to select the most patent meatus and thus we first introduce the concept of anterior "meatus-copy", which is different from "meatoscopy" for the urinary meatus.
The conventional sniff nasal patency test is an inspection of nasal passability by asking a patient to compare the breathing-in air flow in either side of the nose. This is a self-selected and subjective method of choosing just the right or left nostril for transnasal endoscopy.
Nasal septum and nasal turbinates, especially the inferior turbinates, are erectile tissues in the nose, fluctuate greatly in size depending on physiological changes (e.g. body temperature and exercise) and response to inflammation. Often, the sensation of a blocked nose is subjective. The otolaryngologist may find a perfectly patent airway and yet the patient will insist that his nose is clogged up. Therefore, an objective method to evaluate nasal patency would help to avoid a narrowed meatus, thereby reducing nasal pain and epistaxis during nasal anesthesia and transnasal endoscopy.
Methods used to objectively measure nasal patency and resistance include rhinomanometry and acoustic rhinometry. However, these two methods are sophisticated and not straightforward. There is no literature describing the optimal selection method for transnasal endoscopic insertion. Assessments of nasal patency by dynamic methods include nasal peak flow, rhinomanometry, and acoustic rhinometry. However, a convenient endoscopic method of evaluating nasal meatus patency has not been proposed.
Locating on the anterior portion of a meatus, the transnasal endoscope itself can act as a nasoscope to look for the most patent meatus.
We found anterior meatuscopy allows the direct visualisation of the turbinates and meatus without causing discomfort. Thus it may be a useful ancillary technique to select the most patent meatus for scope insertion. Hence, the primary objective of this study is to evaluate whether a anterior meatuscopy scoring system could reduce nasal bleeding and improve tolerance associated with UT-EGD.
- Conditions
- Injury Due to Endoscopic Examination, Transnasal Endoscopy Induced Epistaxis, Transnasal Endoscopy Induced Nasal Pain
- Being tested
- anterior meatoscopy, Nasal sniff test
- Keywords
- Endoscopes, Esophago-gastro-duodenoscopy, Transnasal endoscopy, Anterior meatoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior meatoscopyProcedure or surgery
The nasal vestibule is the most anterior part of the nasal cavity. It is lined by the same epithelium of the skin (stratified squamous epithelium) but not respiratory epithelium (pseudostratified columnar ciliated epithelium) so that an endoscope tip in this region would hardly causes trauma or bleeding. Before being inserted gently into the nasal vestibule for anterior rhinoscopy, the endoscope tip is applied with 2% lidocaine gel and then sprayed with 10% liquid lidocaine. This procedure can provide mild vestibular anesthesia which can prevent patients from sneezing when the vibrissae hair is irritated by the endoscope tip. Instead of holding the insertion tube as usual, an endoscopist holds the bending section for better control of the distal tip during anterior meatuscopy.
Nasal sniff testProcedure or surgery
All patients in the control group receive a sniff test in the left lateral decubitus (LLD) position directed and recorded by an assistant nurse. This test has been conducted for decades and is still used by many transnasal endoscopists, otolaryngologists, and pediatrics. In brief, the more patent nostril is selected by the patient inhaling through only one nostril with the other sealed by the examiner's index finger. Patients are asked to indicate which of their nostrils is most patent. If neither is more patent, the right nostril is chosen by default. The middle meatus is more difficult to examine and may be less well anesthetized than other structures. Thus, the inferior nasal meatus is selected for each case because the inferior meatus is usually the largest of the three nasal meatuses.
| Study group | Role | What they receive |
|---|---|---|
| Anterior meatuscopy | Experimental | All patients in the study group receive anterior meatoscopy whereas patients in the control group perform a sniff test to select the most patent nostril for nasal anesthesia and transnasal endoscopic insertion. Receives: Procedure: anterior meatoscopy |
| Nasal sniff test | Active comparator | A sniff test for nasal patency is a common method before ultrathin transnasal esophago-gastro-duodenoscopy (UT-EGD) to select the right or left nostril for insertion. Receives: Procedure: Nasal sniff test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measures were tolerability profiles on a validated visual analogue scale
The primary outcome measures were tolerability profiles on a validated visual analogue scale as previously described and difficulty in inserting the transnasal endoscope through the selected meatus based on a Likert scale. The scale contained 5 points of difficulty: minimal, slight, moderate, substantial, and extreme. Facing a 5-point VAS card (1 = minimal discomfort to 5 = severe discomfort), all patients gave realtime feedback by speaking or pointing out their scorings for the following: (1) pain during anesthesia, (2) pain during nasal insertions, and (3) pain during exsertion, and they answered immediately after UT-EGD for (4) overall tolerance.
Measured: Immediately after transnasal endoscopy up to all questionnaires answered (about 15 minutes)
Secondary outcomes (1)
Secondary outcome measure evaluates the side effects of transnasal endoscopy
Secondary outcome measures were evaluated by assisting nurses, who recorded epistaxis, patient's willingness to receive the same procedure the next time, and post-procedural side effects including headache, light headiness, mucous discharge, and confirmed sinusitis by otolaryngologist. The visual capacity for the anterior nasal cavity ranking on a 5-point scale (5 represented standard EGD and 1 poor visual quality) was as previously described
Measured: Immediately after transnasal endoscopy up to all questionnaires answered (about 15 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startSep 2012
- Primary completionFeb 2013 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury Due to Endoscopic ExaminationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 233 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi-Tan Hu, Buddhist Tzu Chi General Hospital
- Investigators
- Chi-Tan Hu, MD, PhD, Principal investigator, Budhist Tzu Chi Hospital and Tzu Chi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784237
- Sponsor's protocol ID
- IRB101-77
- Status last verified
- Feb 2013
- First submitted
- 12 Dec 2012
- 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
- Comparison Between an Anterior Rhinoscopic Scoring Scale With the Sniff Test to Predict Nasal Insertability Before Transnasal Endoscopy: A Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT01784237
- Acronym / sponsor ID
- IRB101-77
- Conditions
- Injury Due to Endoscopic Examination, Transnasal Endoscopy Induced Epistaxis, Transnasal Endoscopy Induced Nasal Pain
- Keywords
- Endoscopes, Esophago-gastro-duodenoscopy, Transnasal endoscopy, Anterior meatoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 233 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 5 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.
A sniff test for nasal patency is a common method before ultrathin transnasal esophago-gastro-duodenoscopy (UT-EGD) to select the right or left nostril for insertion, yet there is no objective method to select an appropriate meatus insertion site (MIS) where tolerance and epistaxis rate can be improved.
The investigators hypothesize that that an objective anterior rhinoscopy (to be more specific, the investigators term it "anterior meatoscopy") method might be more effective than the subjective breathing-in method (sniff test) to select the appropriate meatus insertion site, thus reducing nasal bleeding and nasal discomfort.
The aim of this study is to evaluate the effectiveness of an endoscopic meatus scoring scale (EMSS) by anterior meatoscopy (AM) to select a MIS on patient tolerance and adverse events during nasal anesthesia and UT-EGD.
The investigators will perform a prospective randomized-controlled trial to compare patient tolerability and adverse events during nasal anesthesia and endoscopy between the AM-selected and self-selected MIS. A total of 233 consecutive patients with epigastric discomfort (symptoms of non-ulcer dyspepsia) will be included in the study in a large tertiary referral hospital in Taiwan.
Detailed description
Transnasal esophago-gastro-duodenoscopy (UT-EGD) offers physicians and patients a number of advantages compared with conventional peroral EGD (P-EGD) and has become increasingly popular in clinical practice over the past several years. However, insertion failure varying from 2.3% to 62.7% due to tight nasal vault have been reported. Dumortire reported 17.9 % of patient refused UT-EGD due to nasal pain and epistaxis remains to be a common side effect. Therefore a well performed nasal anesthesia has been regarded as the most important step for UT-EGD.
The concept of endoscopic guidance is actually an application of anterior rhinoscopy to select the most patent meatus for nasal anesthesia and endoscopic insertion. The scope should be placed in the side of the nasal cavity that is most patent. Therefore, it is reasonable that a nasal examination is performed prior to UT-EGD to determine the less obstructed side.
In fact, anterior rhinoscopy is a common outpatient procedure by otolaryngologists and is performed with an otoscope. Instead, we use a transnasal endoscope to select the most patent meatus and thus we first introduce the concept of anterior "meatus-copy", which is different from "meatoscopy" for the urinary meatus.
The conventional sniff nasal patency test is an inspection of nasal passability by asking a patient to compare the breathing-in air flow in either side of the nose. This is a self-selected and subjective method of choosing just the right or left nostril for transnasal endoscopy.
Nasal septum and nasal turbinates, especially the inferior turbinates, are erectile tissues in the nose, fluctuate greatly in size depending on physiological changes (e.g. body temperature and exercise) and response to inflammation. Often, the sensation of a blocked nose is subjective. The otolaryngologist may find a perfectly patent airway and yet the patient will insist that his nose is clogged up. Therefore, an objective method to evaluate nasal patency would help to avoid a narrowed meatus, thereby reducing nasal pain and epistaxis during nasal anesthesia and transnasal endoscopy.
Methods used to objectively measure nasal patency and resistance include rhinomanometry and acoustic rhinometry. However, these two methods are sophisticated and not straightforward. There is no literature describing the optimal selection method for transnasal endoscopic insertion. Assessments of nasal patency by dynamic methods include nasal peak flow, rhinomanometry, and acoustic rhinometry. However, a convenient endoscopic method of evaluating nasal meatus patency has not been proposed.
Locating on the anterior portion of a meatus, the transnasal endoscope itself can act as a nasoscope to look for the most patent meatus.
We found anterior meatuscopy allows the direct visualisation of the turbinates and meatus without causing discomfort. Thus it may be a useful ancillary technique to select the most patent meatus for scope insertion. Hence, the primary objective of this study is to evaluate whether a anterior meatuscopy scoring system could reduce nasal bleeding and improve tolerance associated with UT-EGD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior meatuscopy | Experimental | Procedure: anterior meatoscopyAll patients in the study group receive anterior meatoscopy whereas patients in the control group perform a sniff test to select the most patent nostril for nasal anesthesia and transnasal endoscopic insertion. |
| Nasal sniff test | Active comparator | Procedure: Nasal sniff testA sniff test for nasal patency is a common method before ultrathin transnasal esophago-gastro-duodenoscopy (UT-EGD) to select the right or left nostril for insertion. |
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 outpatients with epigastric discomfort (non-ulcer dyspepsia), aged 18-65 years are eligible for this study.
Key exclusion criteria (1 listed)
- Patients who have prior nasal trauma or surgery, recent or present upper gastrointestinal bleeding and coagulopathy are excluded from this study. Patients who are allergic to an anesthetic agent and who have uncontrolled hypertension or coronary artery disease are not recruited. Those who are uncooperative and unable to answer questions are also excluded.
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 |
|---|---|---|
| anterior meatoscopyThe nasal vestibule is the most anterior part of the nasal cavity. It is lined by the same epithelium of the skin (stratified squamous epithelium) but not respiratory epithelium (pseudostratified columnar ciliated epithelium) so that an endoscope tip in this region would hardly causes trauma or bleeding. Before being inserted gently into the nasal vestibule for anterior rhinoscopy, the endoscope tip is applied with 2% lidocaine gel and then sprayed with 10% liquid lidocaine. This procedure can provide mild vestibular anesthesia which can prevent patients from sneezing when the vibrissae hair is irritated by the endoscope tip. Instead of holding the insertion tube as usual, an endoscopist holds the bending section for better control of the distal tip during anterior meatuscopy. | Procedure or surgery | Anterior meatuscopy |
| Nasal sniff testAll patients in the control group receive a sniff test in the left lateral decubitus (LLD) position directed and recorded by an assistant nurse. This test has been conducted for decades and is still used by many transnasal endoscopists, otolaryngologists, and pediatrics. In brief, the more patent nostril is selected by the patient inhaling through only one nostril with the other sealed by the examiner's index finger. Patients are asked to indicate which of their nostrils is most patent. If neither is more patent, the right nostril is chosen by default. The middle meatus is more difficult to examine and may be less well anesthetized than other structures. Thus, the inferior nasal meatus is selected for each case because the inferior meatus is usually the largest of the three nasal meatuses. | Procedure or surgery | Nasal sniff test |
Primary outcome
The primary outcome measures were tolerability profiles on a validated visual analogue scale
Time frame: Immediately after transnasal endoscopy up to all questionnaires answered (about 15 minutes)
The primary outcome measures were tolerability profiles on a validated visual analogue scale as previously described and difficulty in inserting the transnasal endoscope through the selected meatus based on a Likert scale. The scale contained 5 points of difficulty: minimal, slight, moderate, substantial, and extreme. Facing a 5-point VAS card (1 = minimal discomfort to 5 = severe discomfort), all patients gave realtime feedback by speaking or pointing out their scorings for the following: (1) pain during anesthesia, (2) pain during nasal insertions, and (3) pain during exsertion, and they answered immediately after UT-EGD for (4) overall tolerance.
1 secondary outcome
Secondary outcome measure evaluates the side effects of transnasal endoscopy
Time frame: Immediately after transnasal endoscopy up to all questionnaires answered (about 15 minutes)
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.
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.
Chi-Tan Hu, MD, PhD principal investigator
Budhist Tzu Chi Hospital and Tzu Chi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anterior meatoscopy and Nasal sniff test in people with Injury Due to Endoscopic Examination and Transnasal Endoscopy Induced Epistaxis, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
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 Taiwan. 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 Chi-Tan Hu, MD, PhD (+886933995773, chitan.hu@msa.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measures were tolerability profiles on a validated visual analogue scale (time frame: Immediately after transnasal endoscopy up to all questionnaires answered (about 15 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 5 Feb 2013.