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Completed

NCT Number: NCT02612961

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 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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Key information

Conditions

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3mL of normal saline from the pink sodium chloride bullet

Other

Sham Comparator of 3mL normal saline

Other

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. Secretion Volume measured after suctioning patient.

    Time frame: 5 days

Other outcomes

  1. Assessment for Presence of Mucus Plug in tracheostomy tube lumen.

    Time frame: 5 Days

    visual assessment of tracheostomy tube for presence of mucus plug.

  2. 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.

  3. 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.

  4. Time Duration of mechanical ventilation identified through patient's electronic health record.

    Time frame: through study completion, an average of 1 year.

  5. Patient presentation of Dyspnea with saline instillation, assessed by patient's presentation, visual assessment.

    Time frame: 5 Days

  6. 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.

  7. Presence of atelectasis in patient assessed via Chest X-ray in patient's electronic record.

    Time frame: 5 days

  8. presence of tracheitis in patient assessed from patient's electronic record.

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 24, 2015
Registry last updated
Feb 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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