Nasogastric Tube PlacementSONUSNCT06635915
Ultrasound to Check the Position of the Nasogastric Tube
A study testing Postoperative ultrasound in people with Nasogastric Tube Placement, run by Hospital Universitario de Gran Canaria Doctor Negrín at 2 sites in Spain.
Trial summary
The main objective of this study is to evaluate whether the use of ultrasound as a method of checking the normal positioning of the NGT is reliable, without requiring other diagnostic tests. Clinical trial that will include patients who had the NGT placed intraoperatively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasogastric Tube Placement
- What is being tested?
- Postoperative ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 2 sitesSpain
- Study dates
- 15 Oct 2024to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients classified as ASA I-IV according to the American Society of Anesthesiologists
- Patients over 18 years old.
- Informed consent signed by the patient or their family representatives
Who cannot join
- Patients classified as ASA V.
- Patients under 18 years old.
- Refusal to participate in the study.
- Contraindication for nasogastric tube placement: ingestion of caustics, nasal or skull fractures, and cervical surgery.
- Patients with anatomical abnormalities at the cervical or pharyngoesophageal level.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Not yet recruiting
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, 35010
- Recruiting
Hospital Universitario de Gran Canaria Doctor Negrín
Palmas de GRAN Canaria, LAS, Las Palmas, 35002
Ángel Becerra-Bolaños, MD PhD, 676229025, angbecbol@gmail.com
Aurelio Rodríguez-Pérez, MD PhD, arodperp@gobiernodecanarias.org
About this study
Official title: Ultrasound to Check the Adequate Position of the Nasogastric Tube to Improve Patient Management and Safety
The main objective of this study is to evaluate whether the use of ultrasound as a method of checking the normal positioning of the NGT is reliable, without requiring other diagnostic tests. Clinical trial that will include patients who had the NGT placed intraoperatively. 114 patients (57 with NGT and 57 without NGT) will be examined by ultrasound in the immediate postoperative period to diagnose the normal positioning of the NGT or its absence.
Can ultrasound quickly and effectively diagnose the normal positioning of the NGT? Can chest X-ray be avoided by introducing ultrasound in the verification of the normal positioning of the NGT in the immediate postoperative period?
Read the detailed description
The nasogastric tube (NGT) is an essential element of our daily clinical practice, commonly used for the administration of enteral nutrition and medication or for gastric decompression and diagnostic procedures. Despite its common use, it is still an invasive procedure with potential complications. Ultrasound is a noninvasive, inexpensive, widely available and rapid method that can speed up the proper verification of these devices. The main objective of this study is to evaluate whether the use of ultrasound as a method of checking the normal positioning of the NGT is reliable, without requiring other diagnostic tests. Clinical trial that will include patients who had the NGT placed intraoperatively. 114 patients (57 with NGT and 57 without NGT) will be examined by ultrasound in the immediate postoperative period to diagnose the normal positioning of the NGT or its absence. Patients who have had the NGT placed will have had their NGT placed correctly by chest X-ray. The upper part of the patient will be covered for the examiner, who will only have access to the patient's abdomen and will not know which patients have NGT or not.
- Conditions
- Nasogastric Tube Placement
- Being tested
- Postoperative ultrasound
- Keywords
- nasogastric tube placement, ultrasound, postoperative diagnosis, monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative ultrasoundDiagnostic test
Ultrasound will be performed to both groups in the postoperative period to assess the normoposition or the absence of nasogastric tube.
| Study group | Role | What they receive |
|---|---|---|
| Patients with nasogastric tube placed during the intraoperative period. | Experimental | Ultrasound will be performed during the postoperative period to assess the normoposition of nasogastric tube. Receives: Diagnostic Test: Postoperative ultrasound |
| Patients without nasogastric tube placed during the intraoperative period. | Active comparator | Ultrasound will be performed during the postoperative period to assess the absence of nasogastric tube. Receives: Diagnostic Test: Postoperative ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of confirmation of normoposition of the nasogastric tube
Researchers will perform postoperative abdominal ultrasound to verify proper placement of the nasogastric tube in patients who have one or its absence in those who have not had one.
Measured: First postoperative hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start15 Oct 2024
- Primary completion31 Jan 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasogastric Tube PlacementStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Clinical trial that will include patients who have had NGT placed intraoperatively. 114 patients (57 with NGT and 57 without NGT) will be examined by ultrasound in the immediate postoperative period to diagnose the normal positioning of the NGT or its absence. In patients who have had NGT placed, the normal positioning of the NGT will be verified by chest X-ray.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor Negrín
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ángel Becerra, Hospital Universitario de Gran Canaria Doctor Negrín
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635915
- Sponsor's protocol ID
- 2022-300-1
- Acronym
- SONUS
- Status last verified
- Dec 2024
- First submitted
- 7 Oct 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound to Check the Adequate Position of the Nasogastric Tube to Improve Patient Management and Safety
- ClinicalTrials.gov ID
- NCT06635915
- Acronym / sponsor ID
- SONUS / 2022-300-1
- Conditions
- Nasogastric Tube Placement
- Keywords
- nasogastric tube placement, ultrasound, postoperative diagnosis, monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor NegrínUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 10 Oct 2024 (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.
The main objective of this study is to evaluate whether the use of ultrasound as a method of checking the normal positioning of the NGT is reliable, without requiring other diagnostic tests. Clinical trial that will include patients who had the NGT placed intraoperatively. 114 patients (57 with NGT and 57 without NGT) will be examined by ultrasound in the immediate postoperative period to diagnose the normal positioning of the NGT or its absence.
Can ultrasound quickly and effectively diagnose the normal positioning of the NGT? Can chest X-ray be avoided by introducing ultrasound in the verification of the normal positioning of the NGT in the immediate postoperative period?
Detailed description
The nasogastric tube (NGT) is an essential element of our daily clinical practice, commonly used for the administration of enteral nutrition and medication or for gastric decompression and diagnostic procedures. Despite its common use, it is still an invasive procedure with potential complications. Ultrasound is a noninvasive, inexpensive, widely available and rapid method that can speed up the proper verification of these devices. The main objective of this study is to evaluate whether the use of ultrasound as a method of checking the normal positioning of the NGT is reliable, without requiring other diagnostic tests. Clinical trial that will include patients who had the NGT placed intraoperatively. 114 patients (57 with NGT and 57 without NGT) will be examined by ultrasound in the immediate postoperative period to diagnose the normal positioning of the NGT or its absence. Patients who have had the NGT placed will have had their NGT placed correctly by chest X-ray. The upper part of the patient will be covered for the examiner, who will only have access to the patient's abdomen and will not know which patients have NGT or not.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Clinical trial that will include patients who have had NGT placed intraoperatively. 114 patients (57 with NGT and 57 without NGT) will be examined by ultrasound in the immediate postoperative period to diagnose the normal positioning of the NGT or its absence. In patients who have had NGT placed, the normal positioning of the NGT will be verified by chest X-ray.
| Arm | Type | Receives |
|---|---|---|
| Patients with nasogastric tube placed during the intraoperative period. | Experimental | Diagnostic Test: Postoperative ultrasoundUltrasound will be performed during the postoperative period to assess the normoposition of nasogastric tube. |
| Patients without nasogastric tube placed during the intraoperative period. | Active comparator | Diagnostic Test: Postoperative ultrasoundUltrasound will be performed during the postoperative period to assess the absence of nasogastric tube. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients classified as ASA I-IV according to the American Society of Anesthesiologists
- Patients over 18 years old.
- Informed consent signed by the patient or their family representatives
Key exclusion criteria (5 listed)
- Patients classified as ASA V.
- Patients under 18 years old.
- Refusal to participate in the study.
- Contraindication for nasogastric tube placement: ingestion of caustics, nasal or skull fractures, and cervical surgery.
- Patients with anatomical abnormalities at the cervical or pharyngoesophageal level.
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 |
|---|---|---|
| Postoperative ultrasoundUltrasound will be performed to both groups in the postoperative period to assess the normoposition or the absence of nasogastric tube. | Diagnostic test | Patients with nasogastric tube placed during the intraoperative period., Patients without nasogastric tube placed during the intraoperative period. |
Primary outcome
Rate of confirmation of normoposition of the nasogastric tube
Time frame: First postoperative hour.
Researchers will perform postoperative abdominal ultrasound to verify proper placement of the nasogastric tube in patients who have one or its absence in those who have not had one.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative ultrasound in people with Nasogastric Tube Placement, run by Hospital Universitario de Gran Canaria Doctor Negrín at 2 sites in Spain.
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 5 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: looking for participants now, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angel Becerra-Bolaños, MD PhD (+34928450370, angbecbol@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of confirmation of normoposition of the nasogastric tube (time frame: First postoperative hour.). 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 24 Dec 2024.