Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
65 participants
INTERVENTIONAL
2020-12-18
2022-12-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Is Ultrasound Comparable to Chest X-ray in Verification of Intensive Care Patients Enteral Feeding Tube Positioning.
NCT06000384
Bedside Ultrasound Assessment of Feeding Tube Position in the Intensive Care Unit
NCT06077617
Gastric Ultrasound Feeding Tube Placement Confirmation Study
NCT06595537
Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical Ventilation
NCT04795895
Verification of Correct Positioning of a Gastric Tube by Ultrasonography
NCT02866123
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Feeding tubes will be inserted by ICU oncall anaesthesiologist as per protocol. The FTof polyvinyl chloride with calibre of 12-16 French will be used. The Nose-Ear-Xiphoid method will be used to measure the tube insertion distance, adding the distance from tip of the patient's nose to the earlobe and from the earlobe to the xiphoid. The tip of tube lubricated prior to insertion in all cases. Orogastric tube placement will be done if nasal route placement is unsuccessful or contraindicated.
Once the correct placement is confirmed by auscultation and aspirate method, the tube will be secured to patient's nose with adhesive tape. For the purpose of this study, verification of tube placement will be done with bedside ultrasound prior to X-ray.
Ultrasound verification of tube placement will be done by a single investigator who received training on oesophageal and gastric ultrasound from radiologist. 'Sonosite SII' (by Fujifilm Sonosite, Inc) ultrasound machine will be used to conduct this study. A linear probe (L38xi, 10-5MHz) will be placed transversely at the anterior neck and focused on visible part of oesophagus which will be just below the left thyroid lobe. A curved probe (C35x, 8-3MHz) will be placed at subxiphoid area orientated towards left upper abdominal quadrant to visualize the stomach and by angulating the probe towards the left subcostal area, the gastric body can be identified in transversal plane just beside the left lobe of liver as internal landmark.
The ultrasound examination will be considered positive if the FT visualized as a hyperechogenic circle posterior to left thyroid lobe adjacent to trachea, and as a hyperechogenic point in the stomach. If the FT seen in the oesophagus and not in stomach, a 20mls of air will be injected through the FT using pine tip syringe while observing dynamic fogging in the stomach. FT is considered in the gastric body in the presence of fogging. Total duration of ultrasound confirmation of FT will be recorded. Following completion of ultrasound confirmation of FT, a chest x-ray will be done for all the patients as per usual. The chest x-ray will be reviewed by ICU team who are blinded from this study.
Dichotomous results either positive or negative of ultrasound examination and x-ray evaluation will be obtained. The criteria for confirmation of FT via ultrasonography will be the positive neck scan and either positive subxiphoid scan or positive fogging test. The ICU oncall anaesthesiologist will be informed immediately in the event of suspected FD misplacement (negative neck scan, negative subxiphoid scan and negative fogging) and an urgent chest x-ray will be requested. Additional data such as duration of ultrasound examination (procedure time) will be included in this study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
All patients requiring intubations
All intubated patients with feeding tube
Confirmation of feeding tube placement in critically ill patients
Confirmation of feeding tube placement using ultrasonography
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Confirmation of feeding tube placement in critically ill patients
Confirmation of feeding tube placement using ultrasonography
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
2. History or post gastric by-pass surgeries
3. Known history of nasopharyngeal, oesophagus or stomach carcinoma
4. Neck trauma/swelling including goitre
5. Open wounds at neck or epigastric regions
6. Pregnant patients
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universiti Kebangsaan Malaysia Medical Centre
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rufinah Teo
Lecturer and Consultant Anesthesiologist , Department of Anesthesia and Intensive Care
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Canselor Tuanku Muhriz,
Cheras, Kuala Lumpur, Malaysia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gok F, Kilicaslan A, Yosunkaya A. Ultrasound-guided nasogastric feeding tube placement in critical care patients. Nutr Clin Pract. 2015 Apr;30(2):257-60. doi: 10.1177/0884533614567714. Epub 2015 Jan 23.
Kim HM, So BH, Jeong WJ, Choi SM, Park KN. The effectiveness of ultrasonography in verifying the placement of a nasogastric tube in patients with low consciousness at an emergency center. Scand J Trauma Resusc Emerg Med. 2012 Jun 12;20:38. doi: 10.1186/1757-7241-20-38.
Yildirim C, Coskun S, Gokhan S, Pamukcu Gunaydin G, Ozhasenekler A, Ozkula U. Verifying the Placement of Nasogastric Tubes at an Emergency Center: Comparison of Ultrasound with Chest Radiograph. Emerg Med Int. 2018 Dec 18;2018:2370426. doi: 10.1155/2018/2370426. eCollection 2018.
Vigneau C, Baudel JL, Guidet B, Offenstadt G, Maury E. Sonography as an alternative to radiography for nasogastric feeding tube location. Intensive Care Med. 2005 Nov;31(11):1570-2. doi: 10.1007/s00134-005-2791-1. Epub 2005 Sep 20.
Chenaitia H, Brun PM, Querellou E, Leyral J, Bessereau J, Aime C, Bouaziz R, Georges A, Louis F; WINFOCUS (World Interactive Network Focused On Critical Ultrasound) Group France. Ultrasound to confirm gastric tube placement in prehospital management. Resuscitation. 2012 Apr;83(4):447-51. doi: 10.1016/j.resuscitation.2011.11.035. Epub 2011 Dec 29.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FF-2020-505
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.