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NCT02612961 · ClinicalTrials.gov registry record · NA
Normal Saline Use With Suctioning
A NA study of Tracheostomy, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 3
- Enrollment target
- 1
- Study location
NCT02612961 is a NA study of Tracheostomy that has completed, run by Johns Hopkins University. The registered enrollment target is 3 participants, below the 45-participant average among 3 other Tracheostomy trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02612961, a NA study of Tracheostomy, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- OTHER 3mL of normal saline from the pink sodium chloride bullet
- OTHER Sham Comparator of 3mL normal saline
Study Locations (1)
Maryland
- The Johns Hopkins Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2016-01-01 |
| Est. Completion | 2016-01-16 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02612961
The ClinicalTrials.gov registry entry for NCT02612961 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 45-participant average among 3 other Tracheostomy trials with a reported enrollment target (93% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Tracheostomy appearing as the primary indexed condition, and to 2 interventions - of which 3mL of normal saline from the pink sodium chloride bullet is the first listed.
NCT02612961 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT02612961 about?
NCT02612961 is a clinical study titled "Normal Saline Use With Suctioning". 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 ...
What is the current status of trial NCT02612961?
This trial is currently completed. It is a NA study. The enrollment target is 3 participants. The study started on 2016-01-01. Estimated completion is 2016-01-16.
What conditions does trial NCT02612961 study?
This clinical trial studies the following conditions: Tracheostomy.
What interventions are being tested in trial NCT02612961?
The interventions under investigation include: 3mL of normal saline from the pink sodium chloride bullet (OTHER), Sham Comparator of 3mL normal saline (OTHER).
Who is sponsoring clinical trial NCT02612961?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02612961 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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