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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

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

Conditions
-----------------
Dysphagia, Endotracheal Intubation, Intake Status, Swallowing Status

Intervention / Treatment
-----------------
* Procedure: Swallowing and Oral Care Program


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Pre-and post- intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants receiving an SOC Program<br>Participants following prolonged endotracheal intubation receiving a up to 14-day daily Swallowing and Oral Care Program. | Procedure: Swallowing and Oral Care Program<br>* An Swallowing and Oral Care Program involves moisturizing and cleansing oral cavity, massaging salivary gland, oral motor exercise daily, and intake education as needed.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days to reach Oral intake status level 6 | 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. | 21 days post-extubation | 
| whether return to total oral intake within 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. | 21 days post-extubation | 
| pass or fail Three-Step Swallowing Screen at 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. | on 7th day post-extubation | 
| pass or fail Three-Step Swallowing Screen at 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. | on 14th day post-extubation | 
| pass or fail Three-Step Swallowing Screen at 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. | on 21st day post-extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral health status | 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. | on the 2nd, 7th and 14th day post-extubation | 
| Oral stereognosis | 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%). | on the 2nd, 7th and 14th day post-extubation | 
| Oral light-touch sensation | 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. | on the 2nd, 7th and 14th day post-extubation | 
| Oral two-point discrimination | 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. | on the 2nd, 7th and 14th day post-extubation | 
| Tongue and lip strength | The tongue and lip strength assessed using the Iowa Oral Performance Instrument (IOPI System; IOPI Medical LLC, Carnation, WA, USA). | on the 2nd, 7th, and 14th day post-extubation | 
| Salivary secretion | 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. | on the 2nd, 7th, and 14th day post-extubation | 
| Body weight | Body weight | on the 2nd, 7th, 14th and 21th day post-extubation. |