Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273117
Status:
TERMINATED
Last Update Posted:
2006-01-09
First Post:
2006-01-05
Brief Title:
Transnasal and Oral Gastroscopy
Sponsor:
Hvidovre University Hospital
Organization:
Hvidovre University Hospital
Study Overview
Official Title:
Transnasal and Conventional Oral Diagnostic Gastroscopy A Prospective Randomised Study
Status:
TERMINATED
Status Verified Date:
2006-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Two groups of patients were randomised into two groups of either transnasal gastroscopy or conventional type gastroscopy n98 The aim of the study was to evaluate the cardiorespiratory effects and sideeffects of the two methods and to evaluate the technical features of the transnasal endoscope
Detailed Description:
Introduction Esophagogastroduodenoscopy is the gold standard investigation for upper gastrointestinal disorders To make the procedure safer and more comfortable thinner endoscopes for conventional oral or for transnasal intubation have been designed Several trials have been conducted suggesting greater patient tolerance with the thinner scope At the same time scope features have improved and are increasingly compatible with the standard endoscope This prospective randomised study was conducted to evaluate the cardiopulmonary effects the patient tolerance and endoscopist evaluation comparing thin transnasal with conventional transoral endoscopy
Patients and Methods Outpatients referred to diagnostic upper gastrointestinal endoscopy were included consecutively after written informed consent Inclusion criteria were age over 18 years Danish-language no history of disease in the nasal cavity and intended diagnostic endoscopy Ninety-eight patients were included and randomised to either conventional oral gastroscopy OG or transnasal gastroscopy TGThe patients were randomized by consecutively numbered envelopes
The patients answered a questionnaire clarifying their previous experience of gastroscopy and if relevant the discomfort of previous examination and their anxiety for the actual examination on a visual analogue scale VAS scale A post endoscopy questionnaire evaluated discomfort during the examination in general during introduction of the endoscope and for the rest of the examination VAS scale The following parameters were assessed by answering yes or no gagging choking pain from the nose throat and the stomach The patients stated whether the degree of discomfort had been greater lesser or as expected compared to previous endoscopy and whether they in a future gastroscopy would prefer sedation and finally they stated their preference for a future procedure OGTG
TG were carried out using Olympus Videoscope GIF-N230 Olympus Optical Ltd Tokyo Japan with an outer diameter of 6 mm and working length of 925 mm first 15 patients and later Olympus Videoscope GIF-XP160 33 patients with an outer diameter of 59 mm and a working length of 1030 mm OG were carried out using Olympus Videoscope GIF-Q160 with an outer diameter of 95 mm and a working length of 1030 mm
All patients received topical anaesthesia before TG xylocain gel were inhaled into each nostril and before OG xylocain spray 10 mgdose 4 doses were spayed into the pharyngeal cavity Intravenous sedation using midazolam were used only if specifically requested by the patient The patients were positioned in the left lateral recumbent position during the procedures Endoscopies were performed by experienced endoscopists
Arterial oxygen saturation SpO2 and heart rate HR were measured by a pulse oximeter Nellcor Symphony N-3000 Nellcor Puritan Bennet Inc Pleasanton CA twice with an interval of one minute before the procedure twice during the procedure one and three minutes after intubation and finally one and two minutes after extubation The minimum SpO2 and maximum HR were noted as was the duration of the procedure Biopsies were taken when indicated and the qualities of the biopsies were assessed Adverse effects during the endoscopies were noted eg epistaxis
After the endoscopy the endoscopists answered a questionnaire evaluating the following parameters using a VAS score intubation ability to aspirate gastric contents visualization of the esophagus the stomach the bulb and the second part of duodenum The presence of chromatic aberrations after flushing and aspiration were also assessed It was noted whether the length of the scope was sufficient and also in case of TG the presence of uni- or bi-lateral stenosis of the nasal cavity and looping in esophagus If TG could not be carried out the reasons were noted
Finally the endoscopists assessed their total subjective evaluation of the endoscopy on a one-to-six scale one unacceptable six perfect
Patients and Methods Outpatients referred to diagnostic upper gastrointestinal endoscopy were included consecutively after written informed consent Inclusion criteria were age over 18 years Danish-language no history of disease in the nasal cavity and intended diagnostic endoscopy Ninety-eight patients were included and randomised to either conventional oral gastroscopy OG or transnasal gastroscopy TGThe patients were randomized by consecutively numbered envelopes
The patients answered a questionnaire clarifying their previous experience of gastroscopy and if relevant the discomfort of previous examination and their anxiety for the actual examination on a visual analogue scale VAS scale A post endoscopy questionnaire evaluated discomfort during the examination in general during introduction of the endoscope and for the rest of the examination VAS scale The following parameters were assessed by answering yes or no gagging choking pain from the nose throat and the stomach The patients stated whether the degree of discomfort had been greater lesser or as expected compared to previous endoscopy and whether they in a future gastroscopy would prefer sedation and finally they stated their preference for a future procedure OGTG
TG were carried out using Olympus Videoscope GIF-N230 Olympus Optical Ltd Tokyo Japan with an outer diameter of 6 mm and working length of 925 mm first 15 patients and later Olympus Videoscope GIF-XP160 33 patients with an outer diameter of 59 mm and a working length of 1030 mm OG were carried out using Olympus Videoscope GIF-Q160 with an outer diameter of 95 mm and a working length of 1030 mm
All patients received topical anaesthesia before TG xylocain gel were inhaled into each nostril and before OG xylocain spray 10 mgdose 4 doses were spayed into the pharyngeal cavity Intravenous sedation using midazolam were used only if specifically requested by the patient The patients were positioned in the left lateral recumbent position during the procedures Endoscopies were performed by experienced endoscopists
Arterial oxygen saturation SpO2 and heart rate HR were measured by a pulse oximeter Nellcor Symphony N-3000 Nellcor Puritan Bennet Inc Pleasanton CA twice with an interval of one minute before the procedure twice during the procedure one and three minutes after intubation and finally one and two minutes after extubation The minimum SpO2 and maximum HR were noted as was the duration of the procedure Biopsies were taken when indicated and the qualities of the biopsies were assessed Adverse effects during the endoscopies were noted eg epistaxis
After the endoscopy the endoscopists answered a questionnaire evaluating the following parameters using a VAS score intubation ability to aspirate gastric contents visualization of the esophagus the stomach the bulb and the second part of duodenum The presence of chromatic aberrations after flushing and aspiration were also assessed It was noted whether the length of the scope was sufficient and also in case of TG the presence of uni- or bi-lateral stenosis of the nasal cavity and looping in esophagus If TG could not be carried out the reasons were noted
Finally the endoscopists assessed their total subjective evaluation of the endoscopy on a one-to-six scale one unacceptable six perfect
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Ethics commitee nr KA00066m | None | None | None |