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

Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02334774
• Other study ID #: 201411079RIND
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dysphagia
• Endotracheal Intubation
• Intake Status
• Swallowing Status

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (17)

Affoo RH, Trottier K, Garrick R, Mascarenhas T, Jang Y, Martin RE. The Effects of Tooth Brushing on Whole Salivary Flow Rate in Older Adults. Biomed Res Int. 2018 Feb 26;2018:3904139. doi: 10.1155/2018/3904139. eCollection 2018. — View Citation

Boliek CA, Rieger JM, Li SY, Mohamed Z, Kickham J, Amundsen K. Establishing a reliable protocol to measure tongue sensation. J Oral Rehabil. 2007 Jun;34(6):433-41. — View Citation

Brodsky MB, Huang M, Shanholtz C, Mendez-Tellez PA, Palmer JB, Colantuoni E, Needham DM. Recovery from Dysphagia Symptoms after Oral Endotracheal Intubation in Acute Respiratory Distress Syndrome Survivors. A 5-Year Longitudinal Study. Ann Am Thorac Soc. 2017 Mar;14(3):376-383. doi: 10.1513/AnnalsATS.201606-455OC. — View Citation

Chen CC, Wu KH, Ku SC, Chan DC, Lee JJ, Wang TG, Hsiao TY. Bedside screen for oral cavity structure, salivary flow, and vocal production over the 14days following endotracheal extubation. J Crit Care. 2018 Jun;45:1-6. doi: 10.1016/j.jcrc.2017.11.035. Epub 2017 Dec 16. — View Citation

Crary MA, Mann GD, Groher ME. Initial psychometric assessment of a functional oral intake scale for dysphagia in stroke patients. Arch Phys Med Rehabil. 2005 Aug;86(8):1516-20. — View Citation

El Solh A, Okada M, Bhat A, Pietrantoni C. Swallowing disorders post orotracheal intubation in the elderly. Intensive Care Med. 2003 Sep;29(9):1451-5. Epub 2003 Aug 2. — View Citation

Heffner JE. Swallowing complications after endotracheal extubation: moving from "whether" to "how". Chest. 2010 Mar;137(3):509-10. doi: 10.1378/chest.09-2477. — View Citation

Kim MJ, Park YH, Park YS, Song YH. Associations Between Prolonged Intubation and Developing Post-extubation Dysphagia and Aspiration Pneumonia in Non-neurologic Critically Ill Patients. Ann Rehabil Med. 2015 Oct;39(5):763-71. doi: 10.5535/arm.2015.39.5.763. Epub 2015 Oct 26. — View Citation

López-Jornet P, Camacho-Alonso F, Bermejo-Fenoll A. A simple test for salivary gland hypofunction using Oral Schirmer's test. J Oral Pathol Med. 2006 Apr;35(4):244-8. — View Citation

Macht M, King CJ, Wimbish T, Clark BJ, Benson AB, Burnham EL, Williams A, Moss M. Post-extubation dysphagia is associated with longer hospitalization in survivors of critical illness with neurologic impairment. Crit Care. 2013 Jun 20;17(3):R119. doi: 10.1186/cc12791. — View Citation

Macht M, Wimbish T, Clark BJ, Benson AB, Burnham EL, Williams A, Moss M. Postextubation dysphagia is persistent and associated with poor outcomes in survivors of critical illness. Crit Care. 2011;15(5):R231. doi: 10.1186/cc10472. Epub 2011 Sep 29. — View Citation

Park T, Kim Y. Effects of tongue pressing effortful swallow in older healthy individuals. Arch Gerontol Geriatr. 2016 Sep-Oct;66:127-33. doi: 10.1016/j.archger.2016.05.009. Epub 2016 Jun 3. — View Citation

Rassameehiran S, Klomjit S, Mankongpaisarnrung C, Rakvit A. Postextubation Dysphagia. Proc (Bayl Univ Med Cent). 2015 Jan;28(1):18-20. Review. — View Citation

Rech RS, Baumgarten A, Colvara BC, Brochier CW, de Goulart B, Hugo FN, Hilgert JB. Association between oropharyngeal dysphagia, oral functionality, and oral sensorimotor alteration. Oral Dis. 2018 May;24(4):664-672. doi: 10.1111/odi.12809. Epub 2018 Feb 27. — View Citation

Skoretz SA, Flowers HL, Martino R. The incidence of dysphagia following endotracheal intubation: a systematic review. Chest. 2010 Mar;137(3):665-73. doi: 10.1378/chest.09-1823. Review. — View Citation

Su H, Hsiao TY, Ku SC, Wang TG, Lee JJ, Tzeng WC, Huang GH, Chen CC. Tongue weakness and somatosensory disturbance following oral endotracheal extubation. Dysphagia. 2015 Apr;30(2):188-95. doi: 10.1007/s00455-014-9594-x. Epub 2015 Feb 8. — View Citation

Tsai MH, Ku SC, Wang TG, Hsiao TY, Lee JJ, Chan DC, Huang GH, Chen CC. Swallowing dysfunction following endotracheal intubation: Age matters. Medicine (Baltimore). 2016 Jun;95(24):e3871. doi: 10.1097/MD.0000000000003871. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Body weight	Body weight	on the 2nd, 7th, 14th and 21th day post-extubation.