The Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
NCT Number: NCT02612961
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.
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Notify Me18 year–100 year
All sexes
Interventional
Not applicable
Baltimore, Maryland, 21287, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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
Time frame: 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
Time frame: 5 Days
12 item questionnaire developed for patients who are mechanically ventilated or patients with a tracheostomy tube who are not mechanically ventilated.
Time frame: 5 Days
5 item questionnaire developed to assess patient's experience with normal saline instillation.
Time frame: 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
Systolic and Diastolic Blood pressure
Time frame: 5 days
Time frame: 5 Days
visual assessment of tracheostomy tube for presence of mucus plug.
Time frame: through study completion, an average of 1 year.
identified by assessing patient's electronic health record.
Time frame: through study completion, an average of 1 year
Identified based on presence of new infiltrates on chest X-rays, fever > 38°F, Leukopenia (<4000 WBC/mm-squared), or Leukocytosis (≥12,000WBC/mm-squared), positive sputum cultures, and worsening gas exchange documented in patient's electronic health record based on the Center for Disease Control algorithm for clinically defined pneumonia.
Time frame: through study completion, an average of 1 year.
Time frame: 5 Days
Time frame: prior to saline instillation and post suctioning of patient, 3 times daily for 5 consecutive days.
Time frame: 5 days
Time frame: 5 days
Johns Hopkins University
Other
Normal Saline Use With Suctioning: A Randomized-Controlled Trial - Pilot Study
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