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Effects of an Swallowing and Oral Care Program in Patients Following Prolonged Endotracheal Intubation

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National Taiwan University

Status

Completed

Conditions

Intake Status
Swallowing Status
Dysphagia
Endotracheal Intubation

Treatments

Procedure: Swallowing and Oral Care Program

Study type

Interventional

Funder types

Other

Identifiers

NCT02334774
201411079RIND

Details and patient eligibility

About

This pre-and post-intervention study enrolled adult Intensive Care Unit(ICU) patients (≥50 years) successfully extubated after ≥48 hours endotracheal intubation and without preexisting neuromuscular disease or swallowing dysfunction.

All participants received by a trained nurse-administered, hospital-based (up to 14 days) Swallowing and Oral Care(SOC) intervention comprising toothbrushing/salivary gland massage, oral motor exercise, and advice on safe-swallowing strategies.

All participants' daily intake status (21 days) and oral health status, oral sensation(stereognosis, light touch and two-point discrimination), tongue and lip strength, salivary secretion, body weight) were assessed at 2, 7, 14 days post-extubation by a blinded research nurse.

Feasibility was evaluated as time spent providing SOC, patients adherence to SOC components, and adverse event(i.e., coughing, wet voice, or decreased oxygen saturation) during SOC intervention.

Full description

With rapid growth of medical technology, patients receiving oral endotracheal intubation have increased. Although endotracheal intubation is a life-sustaining procedure, its presence can deteriorate the structure and function of oropharynx, which may contribute to the difficulties in swallowing and subsequent oral intake. Estimated 62% of patients who had been intubated ≥48 hours will experience post-extubation dysphagia. Clearly, intervention is needed but studies are lacking in this regard. Thus, the objective of this pilot trial is to evaluate effects of an Oral Swallowing Care Program on swallowing and oral intake status in patients following prolonged endotracheal intubation.

This study employs a pre-and post-intervention design. The investigators were enrolled 63 post-extubated adult patients (50 years old and older) who had prolonged (≥48 hours) oral endotracheal intubation from six medical intensive care units at a medical center in Taipei, Taiwan.

Participants were assessed within 48 hours post-extubation for the baseline data, then a 14-day, daily Swallowing and Oral Care (SOC) Program involves toothbrushing/salivary gland massage, oral exercise(i.e., active/resistive range-of-motion[ROM] exercises for tongue, lips, and jaw), and advice on safe-swallowing strategies.

Outcome were assessed on 2nd, 7th, 14th, and 21st day post-extubation including oral health status, oral sensation (stereognosis, light touch and two-point discrimination), tongue and lip strength, salivary secretion, body weight. In addition, Three-Step Swallowing Screen (3-SSS) and Functional Oral Intake Scale(FOIS) were assessed daily. The data were analyzed by SPSS 12 software package.

Enrollment

63 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

  • Adult patients (50 years old and older)
  • People who had been extubated for over 48 hours and successfully extubated
  • People or their legal representative who agree to participate in this study and sign the permit
  • People who can communicate with Mandarin or Taiwanese

Exclusion criteria

  • People who have diagnosis of neurological diseases such as cerebrovascular disease, Parkinson's disease or spinal injury, etc.
  • People who have abnormal structure or function of oropharynx such as patients with head neck cancer or acquired/ inherited abnormal oropharynx structure
  • People who currently have endotracheostomy
  • People who are unconscious or have mental disability, having difficulty following the protocol or interacting with others
  • People who are absolute quarantined. such as patients with open tuberculosis
  • People who had swallowing difficulties before current intubation

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

63 participants in 1 patient group

Participants receiving an SOC Program
Experimental group
Description:
Participants following prolonged endotracheal intubation receiving a up to 14-day daily Swallowing and Oral Care Program.
Treatment:
Procedure: Swallowing and Oral Care Program

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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