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AdultNCT03262493

Feeding Tube Attachment Device Versus Conventional Fixation and Its Impact on Accidental Exit of Enteral Feeding Tubes

A study testing Interventional Group in people with Adult and Enteral Nutrition, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Enteral nutritional therapy, fed through the gastrointestinal tract via a catheter, tube, catheter, or stoma, delivers the nutrients distally to the oral cavity and may reduce intrahospital malnutrition. Enteral probes are inserted, at the bedside, through the nose or mouth into the stomach or duodenum. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Adult, Enteral Nutrition, Tube Feeding
What is being tested?
Interventional Group
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
1 siteBrazil
Study dates
14 Jun 2017to 31 Mar 2018
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 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults hospitalized in the clinic unit care: 6 sul e 7 norte
  • Use of enteral nutrition in open system

Who cannot join

  • Use of enteral nutrition by gastrostomy or jejunostomy

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Michelli Cristina Silva de Assis

    Porto Alegre, Rio Grande do Sul, 90690270

Other trials in Brazil

About this study

Official title: Use of Feeding Tube Attachment Device Versus Conventional Fixation and Its Impact on Accidental Exit of Enteral Feeding Tubes: Randomized Clinical Trial

Enteral nutritional therapy, fed through the gastrointestinal tract via a catheter, tube, catheter, or stoma, delivers the nutrients distally to the oral cavity and may reduce intrahospital malnutrition. Enteral probes are inserted, at the bedside, through the nose or mouth into the stomach or duodenum. Among the main complications of the use enteral probes, we can mention: displacement of the probe and administration of diet in the respiratory tract or microaspirations. To prevent displacement, enteral probes are attached to the skin on the nose or forehead by the use of micropore-type adhesive. In the probe the adhesive tape is put in the form of "tie" and again fixed to the nose of the patient. The enteral probes displacement rates with this technique are around 62%; in addition, the adhesive tape can cause discomfort, nasal necrosis, skin lesions and skin sensitivity reactions to the patient. More recently the nasal bridle, an anchor of the enteral feeding tube located around the nasal septum or nasal septum, has been described as more effective in securing enteral probes position over traditional tape attachment, but is not available in our environment. In Brazil, the feeding tube attachment device (FTAD) is available. Until now, the performance of FTAD in relation to enteral probe safety and accidental exit rates has not been described in the literature. Material's FTAD is composed of a layer of hydrocolloid that is adhered to the skin on the back of the nose and a polyurethane clamp that secures the enteral probe. Thus, there was a need to evaluate the actual success in using the traditional mode of probe attachment. It should be noted that very little scientific evidence is available in the literature on such care, and this is due to the lack of well-designed studies on the subject.

Read the detailed description

Patients will be randomly assigned to the intervention group consisting of the use of the feeding tube attachment device (FTAD) or the control group that will use the conventional method of attachment with micropore adhesive tape and tape . The data will be compared by Student's t test or Mann-Whitney and Pearson's chi-square, according to their distribution. The project was approved by the Ethics and Research Committee of the Hospital de Clínicas de Porto Alegre. Daily will be accessed through the diet map, available in the hospital application, patients who are in use enteral nutrition. These data will be tabulated in the screening worksheet, those who meet the eligibility criteria will be invited to participate in the study and requested the reading and signing of the informed consent by the patient or guardian. The study investigator will inform the allocation group to the guest patient.By means of a structured questionnaire, socio demographic and clinical information will be collected: age, gender, reason for current hospitalization, comorbidities and information related to enteral probe (type of probe, place and date of insertion, number of medications in use via enteral probe, type and the date of the last fixation change).

Traditional fixation with micropore and plaster is routinely performed by the nursing staff every 24 hours or whenever necessary. The procedure will be performed as described in the study protocol (item 1.1).

The feeding tube attachment device (FTAD) contains a layer of hydrocolloid that will attach to the skin and a clamping clamp around the probe. The placement of the catheter fixation device will be performed by the research nurses, these will be previously trained by the manufacturer of the material. The fixing procedure is described in item 1.2.

Patients included will be evaluated daily for study outcomes up to the suspension of enteral nutrition prescription, hospital discharge, death or up to 35 days of follow-up. Patients starting enteral probe use on Saturday and Sunday can be up to 48 hours with the traditional method of fixation and later will be randomized to the intervention or control group.

1.1 Control Group After inclusion in the study, initial evaluation and information to the patient, the attending nurse will follow up on the exchange of the traditional enteral probe fixation device that occurs according to the standard operating protocol in the institution that recommends micropore fixation according to the "tie" technique and exchange Every 24 hours and whenever it is loose or with presence of dirt.

1.2 Intervention Group

After inclusion in the study and the initial evaluation, the patient will be informed of the intervention to be submitted. The care nurse will place the catheter fixation device, which according to the manufacturer, should follow the following instructions:

  • Wash the patient's nose with soap and water that does not release residue;
  • Rinse vigorously and dry thoroughly.
  • Remove the paper that isolates the adhesive barrier (step 1);
  • Position the device so that the fastener is approximately 1 cm below the tip of the nose. Apply the barrier to the patient's nose, pressing the barrier surface gently against the skin for 60 seconds (step 2);
  • Fasten the feeding probe, closing the clamp around it, and firmly tighten the arms to fully engage the serrated teeth (step 3);
  • To remove, raise clamp. Place the tip of one finger over the ledge on the opposite arm and turn the arm to open (step 4).

The exchange of the device should be every 7 days, in the presence of dirt or if material deterioration occurs.

Being tested
Interventional Group
Keywords
intubation, gastrointestinal, nursing, clinical trial, enteral nutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interventional GroupDevice

    Use of the feeding tube attachment device (FTAD).

Study groups in NCT03262493
Study groupRoleWhat they receive
Interventional GroupExperimentalIt consists of the use of the feeding tube attachment device (FTAD) to fix the enteral probe.
Receives: Device: Interventional Group
Conventional GroupNo interventionIt consists of the fixation of the enteral probe with adhesive tape of the micropore type and plaster.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of accidental enteral probes exit per patient

    Will be accessed by the patient's chart

    Measured: Thirty fifth day

Secondary outcomes (3)
  1. Reasons for the accidental enteral probes exit per patient and / or reintegration of enteral probes between the groups

    Will be accessed by the patient's chart

    Measured: Thirty fifth day

  2. Administrated enteral nutrition volume per patient

    The volume of enteral nutrition received will be accessed by the patient's chart

    Measured: Thirty fifth day

  3. Time of fasting or delay in the use of enteral probes between groups

    Time of fasting will be accessed by the patient's chart

    Measured: Thirty fifth day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2017
  2. Study start14 Jun 2017
  3. Primary completion31 Dec 2017
  4. Study completion31 Mar 2018

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03262493
Sponsor's protocol ID
170217
Status last verified
Aug 2017
First submitted
23 Aug 2017
Last updated
9 Aug 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Interventional Group in people with Adult and Enteral Nutrition, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

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 2 inclusion and 1 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 9 Aug 2018. 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 Brazil. 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?

Number of accidental enteral probes exit per patient (time frame: Thirty fifth day). 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 9 Aug 2018.

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