Normal Saline Use With Suctioning

Study Overview
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Brief Summary
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A long-standing intervention during tracheostomy tube suctioning in acute care settings is use of saline to loosen and remove respiratory tract secretions, maintain airway patency, and prevent mucus plugs. Controversy exists regarding safely using saline prior to suctioning for head and neck cancer and mechanically ventilated patients. To date, all studies had methodological limitations. In 2013, the clinical consensus statement published by AAO-HNSF identified a research gap based on lack of strong scientific evidence. A single site, randomized controlled pilot study will be conducted to evaluate effects of saline instillation with tracheostomy tube suctioning; test feasibility of proposed methods and procedures; and ensure proposed outcome variables are measurable and not confounded by extraneous variables. Institutional review board approval will be obtained before eligible adult subjects (inpatient and intensive care units) are recruited and consented. Oxygen saturation and heart rate are primary outcome variables; secondary outcome variables are mucus plugs and ventilator-associated pneumonias; other demographic data and patient characteristic variables; and outcome variables on complications and length of stay. Mean, standard deviation, median, and interquartile range will be calculated for continuous variables using t-tests to compare pre- and post-assessment scores. Frequencies and percentages will be calculated for categorical variables using Chi square and Fisher Exact tests to compare pre- and post-assessment scores. Multiple regression analysis will be used to control for confounding variables. This study is innovative as the first to recruit both head and neck cancer patients and mechanically ventilated patients and to measure all major outcomes of interest in one study. Understanding the effects of normal saline instillation will enable development of evidence-based guidelines and standardized protocols for tracheostomy tube suctioning.

Official Title
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Normal Saline Use With Suctioning: A Randomized-Controlled Trial - Pilot Study

Conditions
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Tracheostomy

Intervention / Treatment
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* Other: 3mL of normal saline from the pink sodium chloride bullet
* Other: Sham Comparator of 3mL normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult Patients, ages 18 or older, cared for on adult inpatient units/wards. Patients who have a tracheostomy tube. Tracheostomy tube has been in place at lease for 72 hours (to avoid any late effects of anesthesia that was administered at the time of tracheostomy tube placement). Patients must have a physician order to suction the tracheostomy tube at least every 8 hours. This will help us to recruit patients for whom suctioning is already part of standard care. Therefore, patients will not undergo unnecessary suctioning for the purpose of the study. Expected hospitalization to be 5 days or greater after consent. Exclusion Criteria: Fresh tracheostomy that still has bleeding from the stoma (< 72 hours since the surgical placement of a tracheostomy tube). Active respiratory distress or hemodynamic changes that warrant a change in the existing treatment plan. Patients who are expected to die or undergo withdrawal of treatment within 48 hours. Patients who are allergic to latex to avoid a reaction with the red rubber suction catheter that will be used in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Saline Instillation<br>3mL normal saline from pink sodium chloride bullet instilled into tracheostomy immediately prior to suctioning. | Other: 3mL of normal saline from the pink sodium chloride bullet<br> <br> |
| Sham Comparator: Placebo<br>Pretend to instill 3mL of normal saline using empty pink sodium chloride bullet immediately prior to suctioning. | Other: Sham Comparator of 3mL normal saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Oxygen Saturation |  | immediately prior to intervention, immediately after intervention, immediately after suctioning patient, again at 1-minute and 5-minute post-suction. Repeated 3 times daily for 5 consecutive days | 
| Change in Heart Rate |  | immediately prior to intervention, immediately after intervention, immediately after suctioning patient, again at 1-minute and 5-minute post-suction. Repeated 3 times daily for 5 consecutive days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Questionnaire for Mechanically Ventilated ICU patients | 12 item questionnaire developed for patients who are mechanically ventilated or patients with a tracheostomy tube who are not mechanically ventilated. | 5 Days | 
| Patient's Experience with Normal Saline Instillation and Tracheostomy Tube Suctioning Questionnaire. | 5 item questionnaire developed to assess patient's experience with normal saline instillation. | 5 Days | 
| Change in Blood Pressure | Systolic and Diastolic Blood pressure | immediately prior to intervention, immediately after suctioning patient, again at 1-minute and 5-minute post-suction. Repeated 3 times daily for 5 consecutive days | 
| Secretion Volume measured after suctioning patient. |  | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanically ventilated patients, Normal Saline, Tracheostomy Tube Suctioning