NCT06635915

Brief 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. 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?

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 10, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

October 15, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

December 24, 2024

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

October 7, 2024

Last Update Submit

December 20, 2024

Conditions

Keywords

nasogastric tube placementultrasoundpostoperative diagnosismonitoring

Outcome Measures

Primary Outcomes (1)

  • 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.

    First postoperative hour.

Study Arms (2)

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.

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.

Diagnostic Test: Postoperative ultrasound

Interventions

Ultrasound will be performed to both groups in the postoperative period to assess the normoposition or the absence of nasogastric tube.

Patients with nasogastric tube placed during the intraoperative period.Patients without nasogastric tube placed during the intraoperative period.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitario de Gran Canaria Doctor Negrín

Palmas de GRAN Canaria, LAS, Las Palmas, 35002, Spain

RECRUITING

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, 35010, Spain

NOT YET RECRUITING

Central Study Contacts

Angel Becerra-Bolaños, MD PhD

CONTACT

Aurelio Rodríguez-Pérez, MD PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Masking Details
The upper part of the patients will be covered for the investigator, who will only have access to the patient's abdomen and will not know which patients have NGT or not.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 7, 2024

First Posted

October 10, 2024

Study Start

October 15, 2024

Primary Completion

January 31, 2025

Study Completion

February 1, 2025

Last Updated

December 24, 2024

Record last verified: 2024-12

Locations