Normal Saline Use With Suctioning

NCT02612961 | Completed DMC

• 1 other identifier: IRB00054395
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Tracheostomy

Keywords

Mechanically ventilated patients; Normal Saline; Tracheostomy Tube Suctioning

Outcome Measures

Primary Outcomes (2)

• Change in Oxygen Saturation

  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

  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 (4)

• Quality of Life Questionnaire for Mechanically Ventilated ICU patients

  5 Days

• Patient's Experience with Normal Saline Instillation and Tracheostomy Tube Suctioning Questionnaire.

  5 Days

• Change in 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.

  5 days

Other Outcomes (8)

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

  5 Days

• Length of stay in the intensive care unit, wards, hospital.

  through study completion, an average of 1 year.

• Presence of Ventilator Associated Pneumonia based on Center for Disease Control algorithm for clinically defined pneumonia.

  through study completion, an average of 1 year

Study Arms (2)

Saline Instillation

EXPERIMENTAL

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

Placebo

SHAM COMPARATOR

Pretend to instill 3mL of normal saline using empty pink sodium chloride bullet immediately prior to suctioning.

Other: Sham Comparator of 3mL normal saline

Interventions

3mL of normal saline from the pink sodium chloride bullet OTHER

Saline Instillation

Sham Comparator of 3mL normal saline OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (13)

• Halm MA, Krisko-Hagel K. Instilling normal saline with suctioning: beneficial technique or potentially harmful sacred cow? Am J Crit Care. 2008 Sep;17(5):469-72. No abstract available.

  PMID: 18776003 BACKGROUND

• Paratz JD, Stockton KA. Efficacy and safety of normal saline instillation: a systematic review. Physiotherapy. 2009 Dec;95(4):241-50. doi: 10.1016/j.physio.2009.06.002. Epub 2009 Sep 12.

  PMID: 19892088 BACKGROUND

• Dennis-Rouse MD, Davidson JE. An evidence-based evaluation of tracheostomy care practices. Crit Care Nurs Q. 2008 Apr-Jun;31(2):150-60. doi: 10.1097/01.CNQ.0000314475.56754.08.

  PMID: 18360145 BACKGROUND

• American Association for Respiratory Care. AARC Clinical Practice Guidelines. Endotracheal suctioning of mechanically ventilated patients with artificial airways 2010. Respir Care. 2010 Jun;55(6):758-64.

  PMID: 20507660 BACKGROUND

• Mitchell RB, Hussey HM, Setzen G, Jacobs IN, Nussenbaum B, Dawson C, Brown CA 3rd, Brandt C, Deakins K, Hartnick C, Merati A. Clinical consensus statement: tracheostomy care. Otolaryngol Head Neck Surg. 2013 Jan;148(1):6-20. doi: 10.1177/0194599812460376. Epub 2012 Sep 18.

  PMID: 22990518 BACKGROUND

• Caruso P, Denari S, Ruiz SA, Demarzo SE, Deheinzelin D. Saline instillation before tracheal suctioning decreases the incidence of ventilator-associated pneumonia. Crit Care Med. 2009 Jan;37(1):32-8. doi: 10.1097/CCM.0b013e3181930026.

  PMID: 19050607 BACKGROUND

• Reeve JC. Instillation of normal saline before suctioning reduces the incidence of pneumonia in intubated and ventilated adults. Aust J Physiother. 2009;55(2):136. doi: 10.1016/s0004-9514(09)70044-3.

  PMID: 19534012 BACKGROUND

• Kleinpell R. Use of Normal Saline Instillation with Suctioning: The Debate Continues. Critical Care Alert 2009;17(1):1.

  BACKGROUND

• Christensen RD, Henry E, Baer VL, Hoang N, Snow GL, Rigby G, Burnett J, Wiedmeier SE, Faix RG, Eggert LD. A low-sodium solution for airway care: results of a multicenter trial. Respir Care. 2010 Dec;55(12):1680-5.

  PMID: 21122176 BACKGROUND

• Maggiore SM, Lellouche F, Pignataro C, Girou E, Maitre B, Richard JC, Lemaire F, Brun-Buisson C, Brochard L. Decreasing the adverse effects of endotracheal suctioning during mechanical ventilation by changing practice. Respir Care. 2013 Oct;58(10):1588-97. doi: 10.4187/respcare.02265. Epub 2013 Mar 6.

  PMID: 23466423 BACKGROUND

• Evans J, Syddall S, Butt W, Kinney S. Comparison of open and closed suction on safety, efficacy and nursing time in a paediatric intensive care unit. Aust Crit Care. 2014 May;27(2):70-4; quiz 75-6. doi: 10.1016/j.aucc.2014.01.003. Epub 2014 Mar 11.

  PMID: 24636425 BACKGROUND

• 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.

  BACKGROUND

• Caparros AC. Mechanical ventilation and the role of saline instillation in suctioning adult intensive care unit patients: an evidence-based practice review. Dimens Crit Care Nurs. 2014 Jul-Aug;33(4):246-53. doi: 10.1097/DCC.0000000000000049.

  PMID: 24895955 BACKGROUND

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 24, 2015
• Study Start: January 1, 2016
• Primary Completion: January 16, 2016
• Study Completion: January 16, 2016
• Last Updated: February 26, 2018

Record last verified: 2018-02

Locations

US (1)