Normal Saline Use With Suctioning

February 22, 2018 updated by: Johns Hopkins University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • The Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Saline Instillation
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
Sham Comparator: Placebo
Pretend to instill 3mL of normal saline using empty pink sodium chloride bullet immediately prior to suctioning.
Other: Sham Comparator of 3mL normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Oxygen Saturation
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
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
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
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
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.
5 Days
Patient's Experience with Normal Saline Instillation and Tracheostomy Tube Suctioning Questionnaire.
Time Frame: 5 Days
5 item questionnaire developed to assess patient's experience with normal saline instillation.
5 Days
Change in Blood Pressure
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
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.
Time Frame: 5 days
5 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment for Presence of Mucus Plug in tracheostomy tube lumen.
Time Frame: 5 Days
visual assessment of tracheostomy tube for presence of mucus plug.
5 Days
Length of stay in the intensive care unit, wards, hospital.
Time Frame: through study completion, an average of 1 year.
identified by assessing patient's electronic health record.
through study completion, an average of 1 year.
Presence of Ventilator Associated Pneumonia based on Center for Disease Control algorithm for clinically defined pneumonia.
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.
through study completion, an average of 1 year
Time Duration of mechanical ventilation identified through patient's electronic health record.
Time Frame: through study completion, an average of 1 year.
through study completion, an average of 1 year.
Patient presentation of Dyspnea with saline instillation, assessed by patient's presentation, visual assessment.
Time Frame: 5 Days
5 Days
change in presence of bleeding through tracheostomy tube during intervention, assessed visually.
Time Frame: prior to saline instillation and post suctioning of patient, 3 times daily for 5 consecutive days.
prior to saline instillation and post suctioning of patient, 3 times daily for 5 consecutive days.
Presence of atelectasis in patient assessed via Chest X-ray in patient's electronic record.
Time Frame: 5 days
5 days
presence of tracheitis in patient assessed from patient's electronic record.
Time Frame: 5 days
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

January 16, 2016

Study Completion (Actual)

January 16, 2016

Study Registration Dates

First Submitted

November 18, 2015

First Submitted That Met QC Criteria

November 23, 2015

First Posted (Estimate)

November 24, 2015

Study Record Updates

Last Update Posted (Actual)

February 26, 2018

Last Update Submitted That Met QC Criteria

February 22, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00054395

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tracheostomy

Clinical Trials on 3mL of normal saline from the pink sodium chloride bullet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe