Normal Saline Use With Suctioning
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 12/9/2017 |
| Start Date: | January 2016 |
| End Date: | December 2019 |
| Contact: | Vinciya Pandian, PhD, RN, ACNP-BC |
| Email: | vpandia1@jhmi.edu |
| Phone: | 443-655-3482 |
Normal Saline Use With Suctioning: A Randomized-Controlled Trial - Pilot Study
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.
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.
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.
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