NCT02612961

Normal Saline Use With Suctioning

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Tracheostomy

Interventions

Type	Name	Description
OTHER	3mL of normal saline from the pink sodium chloride bullet
OTHER	Sham Comparator of 3mL normal saline

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-01-16
• Completion: 2016-01-16
• First posted: 2015-11-24
• Last updated: 2018-02-26

Locations

1 site across 1 country: United States