TracheostomyNCT02612961
Normal Saline Use With Suctioning
A study testing 3mL of normal saline from the pink sodium chloride bullet in people with Tracheostomy, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Tracheostomy
- What is being tested?
- 3mL of normal saline from the pink sodium chloride bullet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2016to 16 Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
About this study
Official title: 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.
- Conditions
- Tracheostomy
- Being tested
- 3mL of normal saline from the pink sodium chloride bullet, Sham Comparator of 3mL normal saline
- Keywords
- Mechanically ventilated patients, Normal Saline, Tracheostomy Tube Suctioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3mL of normal saline from the pink sodium chloride bulletOther
Sham Comparator of 3mL normal salineOther
| Study group | Role | What they receive |
|---|---|---|
| Saline Instillation | Experimental | 3mL normal saline from pink sodium chloride bullet instilled into tracheostomy immediately prior to suctioning. Receives: 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. Receives: Other: Sham Comparator of 3mL normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oxygen Saturation
Measured: 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
Measured: 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
12 item questionnaire developed for patients who are mechanically ventilated or patients with a tracheostomy tube who are not mechanically ventilated.
Measured: 5 Days
Patient's Experience with Normal Saline Instillation and Tracheostomy Tube Suctioning Questionnaire.
5 item questionnaire developed to assess patient's experience with normal saline instillation.
Measured: 5 Days
Change in Blood Pressure
Systolic and Diastolic Blood pressure
Measured: 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.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study start1 Jan 2016
- Primary completion16 Jan 2016
- Study completion16 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for TracheostomyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612961
- Sponsor's protocol ID
- IRB00054395
- Status last verified
- Feb 2018
- First submitted
- 18 Nov 2015
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18776003Paratz 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.
PubMed 19892088Dennis-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.
PubMed 18360145American 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.
PubMed 20507660Mitchell 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.
PubMed 22990518Caruso 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.
PubMed 19050607Reeve 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.
PubMed 19534012Kleinpell R. Use of Normal Saline Instillation with Suctioning: The Debate Continues. Critical Care Alert 2009;17(1):1.
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.
PubMed 21122176Maggiore 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.
PubMed 23466423Evans 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.
PubMed 24636425Iranmanesh, 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.
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.
PubMed 24895955
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Saline Use With Suctioning: A Randomized-Controlled Trial - Pilot Study
- ClinicalTrials.gov ID
- NCT02612961
- Acronym / sponsor ID
- IRB00054395
- Conditions
- Tracheostomy
- Keywords
- Mechanically ventilated patients, Normal Saline, Tracheostomy Tube Suctioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 16 Jan 2016 (actual)
- Study completion
- 16 Jan 2016 (actual)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline Instillation | Experimental | Other: 3mL of normal saline from the pink sodium chloride bullet3mL normal saline from pink sodium chloride bullet instilled into tracheostomy immediately prior to suctioning. |
| Placebo | Sham comparator | Other: Sham Comparator of 3mL normal salinePretend to instill 3mL of normal saline using empty pink sodium chloride bullet immediately prior to suctioning. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3mL of normal saline from the pink sodium chloride bullet | Other | Saline Instillation |
| Sham Comparator of 3mL normal saline | Other | Placebo |
Primary outcome
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
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
4 secondary outcomes
Quality of Life Questionnaire for Mechanically Ventilated ICU patients
Time frame: 5 Days
Patient's Experience with Normal Saline Instillation and Tracheostomy Tube Suctioning Questionnaire.
Time frame: 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
Secretion Volume measured after suctioning patient.
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- Background: PubMed 18776003Halm 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.
- Background: PubMed 19892088Paratz 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.
- Background: PubMed 18360145Dennis-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.
- Background: PubMed 20507660American 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.
- Background: PubMed 22990518Mitchell 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.
- Background: PubMed 19050607Caruso 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.
- Background: PubMed 19534012Reeve 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.
- BackgroundKleinpell R. Use of Normal Saline Instillation with Suctioning: The Debate Continues. Critical Care Alert 2009;17(1):1.
- Background: PubMed 21122176Christensen 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.
- Background: PubMed 23466423Maggiore 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.
- Background: PubMed 24636425Evans 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.
- BackgroundIranmanesh, 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3mL of normal saline from the pink sodium chloride bullet in people with Tracheostomy, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02612961, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2018.