NCT03670238

Brief Summary

Feeding by tube is commonly used for inpatients and ambulatory patients. For this purpose nasogastric (NG) intubation is the traditional approach. The aim of this study was to develop the orogastric (OG) intubation with dental fixation and compare OG versus NG intubation in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
Last Updated

September 28, 2018

Status Verified

September 1, 2018

Enrollment Period

9 months

First QC Date

August 26, 2018

Last Update Submit

September 26, 2018

Conditions

Feeding Patterns

Keywords

Nasogastric intubationOrogastric intubationFeeding tubes

Outcome Measures

Primary Outcomes (1)

  • Tolerance

    Period in hours (maximum 24 hours) that the patients tolerated the intubation, ranging from zero to 24 hours.

    two days

Secondary Outcomes (6)

  • Discomfort

    two days

  • Handling

    two days

  • Speech

    two days

  • Esthetic

    two days

  • Deglutition

    two days

  • +1 more secondary outcomes

Study Arms (2)

Orogastric intubation

EXPERIMENTAL

Orogastric intubation using a polyurethane enteral tube followed by fixation of the tube tip to a superior molar.

Device: Orogastric intubation

Nasogastric intubation

ACTIVE COMPARATOR

Nasogastric intubation using a polyurethane enteral tube followed by fixation of the tube to the patient face.

Device: Nasogastric intubation

Interventions

Orogastric intubationDEVICE

Patient was placed in Fowler position (45º) and intraoral infiltrative anesthesia was carried out with Lidocaine 2% (without vasoconstrictor) at gingival papilla in the vestibular-palatine direction. A polyurethane enteral tube (Medicone®, Cachoeirinha - Brazil) was inserted through the mouth and passed into de stomach, followed by fixation of the tube tip to a superior molar or premolar, in its palatine surface. For dental amarry it waas used a suture wire in stainless steel size 1.0

Orogastric intubation
Nasogastric intubationDEVICE

After nostril anesthesia with xylocaine gel, a polyurethane enteral tube was inserted through the nose and its tip was positioned in the gastric lumen, according to the nose-ear-xiphoid method. The tube was attached to the face using antiallergic adhesive tape.

Nasogastric intubation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 70 years;
  • Healthy volunteers;
  • Individuals to participate in the study who referred to becoming superior of the subsequent intact students (Molars or premolars, either side);
  • Individuals of both sexes.

You may not qualify if:

  • Gastroesophageal complaints;
  • Limitation of mouth opening;
  • Pathologies of airways;
  • Individuals invited to the study who reported bilateral upper posterior tooth loss;
  • Inability to respond to the questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renato dos Santos

Passo Fundo, Rio Grande do Sul, 99020060, Brazil

Location

Related Publications (1)

  • Dos Santos R, Della Bona A, Fornari F. Orogastric intubation with dental fixation for enteral nutrition: a proof-of-concept study. Br J Oral Maxillofac Surg. 2021 Jul;59(6):672-677. doi: 10.1016/j.bjoms.2020.08.098. Epub 2020 Aug 25.

    PMID: 33985848DERIVED

MeSH Terms

Conditions

Feeding Behavior

Interventions

Intubation, Gastrointestinal

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

IntubationTherapeuticsInvestigative Techniques

Study Officials

  • Fernando Fornari, Professor

    Universidade de Passo Fundo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A cross-over randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 26, 2018

First Posted

September 13, 2018

Study Start

August 10, 2016

Primary Completion

May 10, 2017

Study Completion

December 10, 2017

Last Updated

September 28, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)