Feeding TubeNCT05307900
Ultrasonography Confirmation of Feeding Tube Placement
A study testing Confirmation of feeding tube placement in critically ill patients in people with Feeding Tube, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
Trial summary
To compare the correct placement of feeding tube in critically ill patients in ICU using ultrasonography versus chest radiography Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Feeding Tube
- What is being tested?
- Confirmation of feeding tube placement in critically ill patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteMalaysia
- Study dates
- 18 Dec 2020to 10 Dec 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All the patients, aged > 18 years old that admitting to ICU who require feeding tube insertion
Who cannot join
- Any contraindications for FT insertion. e.g. coagulopathy, oesophageal varices
- History or post gastric by-pass surgeries
- Known history of nasopharyngeal, oesophagus or stomach carcinoma
- Neck trauma/swelling including goitre
- Open wounds at neck or epigastric regions
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasonography Confirmation of Feeding Tube Placement in Critically Ill Patients
To compare the correct placement of feeding tube in critically ill patients in ICU using ultrasonography versus chest radiography
Read the detailed description
Patients who are indicated for feeding tube (FT) placement in ICU will be recruited in this study. Written informed consent will be obtained from next of kin.
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
- Feeding Tube
- Being tested
- Confirmation of feeding tube placement in critically ill patients
- Keywords
- ultrasonography, ryle's tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confirmation of feeding tube placement in critically ill patientsOther
Confirmation of feeding tube placement using ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| All patients requiring intubations | Experimental | All intubated patients with feeding tube Receives: Other: Confirmation of feeding tube placement in critically ill patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the correct placement of feeding tube in critically ill patients in ICU using ultrasonography versus chest radiography
Numbers of positive ultrasound verifications of correct placement of feeding tube
Measured: 1 year
Secondary outcomes (1)
To study time taken to perform USG examination to confirm feeding tube placement in critically ill patients
Total duration of ultrasound examination to verify correct placement of feeding tube
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start18 Dec 2020
- Primary completion10 Mar 2022
- Study completion10 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Feeding TubeStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rufinah Teo, Universiti Kebangsaan Malaysia Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307900
- Sponsor's protocol ID
- FF-2020-505
- Status last verified
- May 2023
- First submitted
- 24 Mar 2022
- Last updated
- 19 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25616518Kim 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.
PubMed 22691418Yildirim 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.
PubMed 30662772Vigneau 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.
PubMed 16172849Chenaitia 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.
PubMed 22209831
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonography Confirmation of Feeding Tube Placement in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT05307900
- Acronym / sponsor ID
- FF-2020-505
- Conditions
- Feeding Tube
- Keywords
- ultrasonography, ryle's tube
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical CentreUniversity, hospital or other
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 10 Dec 2022 (actual)
- First posted
- 1 Apr 2022 (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.
To compare the correct placement of feeding tube in critically ill patients in ICU using ultrasonography versus chest radiography
Detailed description
Patients who are indicated for feeding tube (FT) placement in ICU will be recruited in this study. Written informed consent will be obtained from next of kin.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients requiring intubations | Experimental | Other: Confirmation of feeding tube placement in critically ill patientsAll intubated patients with feeding tube |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All the patients, aged > 18 years old that admitting to ICU who require feeding tube insertion
Key exclusion criteria (6 listed)
- Any contraindications for FT insertion. e.g. coagulopathy, oesophageal varices
- History or post gastric by-pass surgeries
- Known history of nasopharyngeal, oesophagus or stomach carcinoma
- Neck trauma/swelling including goitre
- Open wounds at neck or epigastric regions
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 |
|---|---|---|
| Confirmation of feeding tube placement in critically ill patientsConfirmation of feeding tube placement using ultrasonography | Other | All patients requiring intubations |
Primary outcome
To compare the correct placement of feeding tube in critically ill patients in ICU using ultrasonography versus chest radiography
Time frame: 1 year
Numbers of positive ultrasound verifications of correct placement of feeding tube
1 secondary outcome
To study time taken to perform USG examination to confirm feeding tube placement in critically ill patients
Time frame: 1 year
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 19 May 2023.
- Results publication: PubMed 25616518Gok 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.
- Results publication: PubMed 22691418Kim 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.
- Results publication: PubMed 30662772Yildirim 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.
- Results publication: PubMed 16172849Vigneau 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.
- Results publication: PubMed 22209831Chenaitia 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.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Confirmation of feeding tube placement in critically ill patients in people with Feeding Tube, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
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 6 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 19 May 2023. 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 Malaysia. 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?
To compare the correct placement of feeding tube in critically ill patients in ICU using ultrasonography versus chest radiography (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05307900, which also lists 5 linked publications.
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 19 May 2023.