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Normal Saline Use With Suctioning

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ClinicalTrials.gov Identifier: NCT02612961
Recruitment Status : Completed
First Posted : November 24, 2015
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief 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.

Condition or disease Intervention/treatment Phase
Tracheostomy Other: 3mL of normal saline from the pink sodium chloride bullet Other: Sham Comparator of 3mL normal saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Normal Saline Use With Suctioning: A Randomized-Controlled Trial - Pilot Study
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : January 16, 2016
Actual Study Completion Date : January 16, 2016

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02612961


Locations
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United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University

Publications:
Kleinpell R. Use of Normal Saline Instillation with Suctioning: The Debate Continues. Critical Care Alert 2009;17(1):1.
Iranmanesh, Sedigheh, Rafiei, Hossein. Normal saline instillation with suctioning and its effect on oxygen saturation, heart rate, and cardiac rhythm. Int J Nurs Educ 2011;3(1):42.

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02612961     History of Changes
Other Study ID Numbers: IRB00054395
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Keywords provided by Johns Hopkins University:
Mechanically ventilated patients
Normal Saline
Tracheostomy Tube Suctioning