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Completed

NCT Number: NCT02334774

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

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.

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Endotracheal Intubation Esophageal Diseases Gastrointestinal Diseases Intake Status Otorhinolaryngologic Diseases Pharyngeal Diseases Swallowing Status

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Swallowing and Oral Care Program

Procedure

An Swallowing and Oral Care Program involves moisturizing and cleansing oral cavity, massaging salivary gland, oral motor exercise daily, and intake education as needed.

Primary outcomes

  1. Days to reach Oral intake status level 6

    Time frame: 21 days post-extubation

    Using the "Functional Oral Intake Scale (FOIS)", a validated tool with established validity (81%-98%) and inter-rater reliabilities (0.86 to 0.91). The scale ranges from levels 1 to 7, level 1=Nothing by mouth; level 2=Tube dependent with minimal attempts of food or liquid; level 3=Tube dependent with consistent oral intake of food or liquid; level 4=Total oral diet of a single consistency; level 5=Total oral diet with multiple consistencies, but requiring special preparation or compensations; level 6=Total oral diet with multiple consistencies with special preparation, but with specific food limitations; level 7=Total oral diet with no restrictions.

  2. whether return to total oral intake within 21 days post extubation

    Time frame: 21 days post-extubation

    Using the "Functional Oral Intake Scale (FOIS)", a validated tool with established validity (81%-98%) and inter-rater reliabilities (0.86 to 0.91). The scale ranges from levels 1 to 7, level 1=Nothing by mouth; level 2=Tube dependent with minimal attempts of food or liquid; level 3=Tube dependent with consistent oral intake of food or liquid; level 4=Total oral diet of a single consistency; level 5=Total oral diet with multiple consistencies, but requiring special preparation or compensations; level 6=Total oral diet with multiple consistencies with special preparation, but with specific food limitations; level 7=Total oral diet with no restrictions.

  3. pass or fail Three-Step Swallowing Screen at 7th day post-extubation

    Time frame: on 7th day post-extubation

    Evaluation by using Three-Step Swallowing Screen(3-SSS). Participants were first assessed for prior history of dysphagia/feeding-tube dependence and signs of consciousness change, poor oxygen saturation (i.e., SaO2<90%; oxygen-mask dependence; reintubation), obvious drooling, or frequent choking on saliva. If negative, participants were then asked to swallow 3mL of water. If laryngeal elevation was identified with no signs of choking or wet voice, participants were asked to swallow 50mL of water; those without any signs of choking, wet voice, or slow swallowing were considered to pass the 3-SSS.

  4. pass or fail Three-Step Swallowing Screen at 14th day post-extubation

    Time frame: on 14th day post-extubation

    Evaluation by using Three-Step Swallowing Screen(3-SSS). Participants were first assessed for prior history of dysphagia/feeding-tube dependence and signs of consciousness change, poor oxygen saturation (i.e., SaO2<90%; oxygen-mask dependence; reintubation), obvious drooling, or frequent choking on saliva. If negative, participants were then asked to swallow 3mL of water. If laryngeal elevation was identified with no signs of choking or wet voice, participants were asked to swallow 50mL of water; those without any signs of choking, wet voice, or slow swallowing were considered to pass the 3-SSS.

  5. pass or fail Three-Step Swallowing Screen at 21st day post-extubation

    Time frame: on 21st day post-extubation

    Evaluation by using Three-Step Swallowing Screen(3-SSS). Participants were first assessed for prior history of dysphagia/feeding-tube dependence and signs of consciousness change, poor oxygen saturation (i.e., SaO2<90%; oxygen-mask dependence; reintubation), obvious drooling, or frequent choking on saliva. If negative, participants were then asked to swallow 3mL of water. If laryngeal elevation was identified with no signs of choking or wet voice, participants were asked to swallow 50mL of water; those without any signs of choking, wet voice, or slow swallowing were considered to pass the 3-SSS.

Secondary outcomes

  1. Oral health status

    Time frame: on the 2nd, 7th and 14th day post-extubation

    The oral health status evaluated by Oral Assessment Guide(OAG), a validated tool with established validity and inter-rater reliabilities. The scores was coded as "1=no change", "2=moderate change", "3= severe change" of eight categories (voice, ability to swallow, lips, saliva, tongue, mucous membrane, gingiva, teeth). All scores are summed, ranges from 3 to 24.

  2. Oral stereognosis

    Time frame: on the 2nd, 7th and 14th day post-extubation

    Oral stereognosis was measured by a set of five standardized researcher-made acrylic resin shapes (round, square, star, oval, and triangular), as suggested. Participants were given 30 s to visually inspect the test pieces along with the diagram of corresponding shapes before testing began.The variable are depicted in term of percentage of participants answered correct shape of each test piece (ranges 0~100%).

  3. Oral light-touch sensation

    Time frame: on the 2nd, 7th and 14th day post-extubation

    Oral light touch sensation was measured with Semmes-Weinstein monofilaments. A standardized set of 5 monofilaments with values from 1.65 to 3.22 (log force) was used.

  4. Oral two-point discrimination

    Time frame: on the 2nd, 7th and 14th day post-extubation

    The stereognostic ability of the tongue was tested using the MacKinnon-Dellon Disk-criminator. The variable are depicted in term of distance in millimeter (mm) when two-point sensation was perceived by participants.

  5. Tongue and lip strength

    Time frame: on the 2nd, 7th, and 14th day post-extubation

    The tongue and lip strength assessed using the Iowa Oral Performance Instrument (IOPI System; IOPI Medical LLC, Carnation, WA, USA).

  6. Salivary secretion

    Time frame: on the 2nd, 7th, and 14th day post-extubation

    Record salivary secretion using Modified Schirmer's test. With participants sitting upright, research nurses held a standardized 1-cm wide by 17-cm long Schirmer tear test strip vertically, with the rounded end of the strip placed at the floor of their mouth. At the end of 5 minutes, a wetting length in centimeter (cm) was recorded.

  7. Body weight

    Time frame: on the 2nd, 7th, 14th and 21th day post-extubation.

    Body weight

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 8, 2015
Registry last updated
Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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