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

Status Completed

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Dysphagia
• Endotracheal Intubation
• Intake Status
• Swallowing Status

• NCT number: NCT02334774
• Study type: Interventional
• Source: National Taiwan University Hospital
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Completion date: December 2015