Endotracheal TubeSMASHNCT03940118
Safety of Mechanical Insufflation-exsufflation and Hypertonic Saline
A study testing Catheter secretion suctioning, Secretion suctioning + hypertonic saline and Ins-exsufflation in people with Endotracheal Tube and Tracheostomy, run by Hospital San Carlos, Madrid at 1 site in Spain.
Trial summary
Conventional catheter suctioning of respiratory tract secretions is a mandatory procedure in intubated patients. Poor tolerance, pain and other, sometimes severe, lung and cardiovascular complications may occur during suctioning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endotracheal Tube, Tracheostomy
- What is being tested?
- Catheter secretion suctioning, Secretion suctioning + hypertonic saline and Ins-exsufflation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2018to 30 Apr 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Artificial airway ( endotracheal tube or tracheostomy cannula) with pressure cuff.
- Need for aspiration of secretions
- Informed consent
Who cannot join
- Macroscopic hemoptysis.
- Acute bronchospasm
- Uncrontrolled muscular contractions, like tremor, myoclonus or other.
- Confirmed pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study on the Safety and Tolerability of Mechanical Insufflation-exsufflation and Hypertonic Saline With Hyaluronic Acid for Suctioning of Respiratory Tract Secretions in Patients With Artificial Airway
Conventional catheter suctioning of respiratory tract secretions is a mandatory procedure in intubated patients. Poor tolerance, pain and other, sometimes severe, lung and cardiovascular complications may occur during suctioning.
Mechanical insufflation-exsufflation (MIE), coupled with hypertonic saline (HS), may improve efficacy airway clearance and reduce risk of the maneuver. However, safety of MIE and HS in intubated patients have not been studied appropriately, which justifies a randomized evaluation compared to conventional secretion suctioning.
Read the detailed description
Secretion suctioning (SS) in patients with artificial airway is a mandatory procedure, although occasionally painful, not tolerated and even causing traumatic injury to the respiratory mucosa.
Mechanical insufflation-exsufflation (MIE) and nebulized hypertonic saline with hyaluronic acid (HS-HA) have shown efficacy and safety in patients with chronic neuromuscular and pulmonary diseases, achieving aspiration and fluidification of respiratory secretions, respectively, as well as good tolerance.
Only anecdotal experience about the safety of MIE and HS-HA in critically ill patients with artificial airway and mechanical ventilation is available.
Background: Both MIE and HS-HA facilitate the drainage of secretions from the distal airway (compared to conventional catheter suctioning, the effect of which is supposed to be limited to the trachea) Both measures may prove to be efficacious in the prevention (through airway clearance of secretions) and concomitant treatment (reduction of inoculum or "draining the lung") of lower respiratory tract infections (tracheobronchitis and pneumonia).
- Conditions
- Endotracheal Tube, Tracheostomy
- Being tested
- Catheter secretion suctioning, Secretion suctioning + hypertonic saline, Ins-exsufflation, Ins-exsufflation + Hypertonic saline
- Keywords
- respiratory secretion suctioning, mechanical insufflation exsufflation, hypertonic saline, hyaluronic acid, critically ill, artificial airway
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter secretion suctioningDevice
Catheter secretion suctioning with prior nebulization of hypertonic saline
Secretion suctioning + hypertonic salineCombination product
Catheter secretion suctioning with prior nebulization of hypertonic saline
Ins-exsufflationDevice
Application of a mechanical insufflation-exsufflation device for respiratory tract secretion suctioning
Ins-exsufflation + Hypertonic salineCombination product
Application of a mechanical insufflation-exsufflation device for respiratory tract secretion suctioning
| Study group | Role | What they receive |
|---|---|---|
| Catheter secretion suctioning | Active comparator | Secretions are aspirated with a catheter at -120 to -150 mBar Receives: Device: Catheter secretion suctioning |
| Secretion suctioning + hypertonic saline | Experimental | Hypertonic saline is nebulized prior to aspiration of secretions. Receives: Combination Product: Secretion suctioning + hypertonic saline |
| Ins-exsufflation | Experimental | Mechanical insufflation-exsufflation with device programmed at 50/-50 mmHg Receives: Device: Ins-exsufflation |
| Ins-exsufflation + Hypertonic Saline | Experimental | Mechanical insufflation-exsufflation and hypertonic saline Receives: Combination Product: Ins-exsufflation + Hypertonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aggregate cardiovascular and respiratory adverse events of mechanical insufflation-exsufflation and hypertonic saline.
Comparative incidence of aggregate hemodynamic and respiratory adverse events.
Adverse events criteria are predefined and will be expressed as:
- Percentage of patients meeting aggregate predefined hemodynamic or respiratory adverse event criteria per study group.
- Percentage of specific predefined adverse events (outcome variable "yes" or "no"): Desaturation (pulse-oximetry, >5%), hemoptisis (yes or no), bronchospasm (needing bronchodilator therapy), pneumothorax (as assessed by chest X-ray), hypotension (>30% or >10% increase in noradrenaline infusion from baseline), hypertension (>30% or >10% decrease in noradrenaline infusion from baseline), tachycardia (>90 bpm or >30% increase), bradycardia (<40 bpm), arrythmias (supra ventricular, requiring therapy), atelectasis (as assessed by chest X-ray), and other complications occuring during or within 1 hour after the procedure.
Measured: 1 hour
Pain score during mechanical insufflation-exsufflation and hypertonic saline as assessed by quantitative a pain scoring systems.
Comparative pain scores of the study procedures in the 4 study groups will be assessed using the "ESCID" pain score (EScala de Conductas Indicadoras de Dolor, ranging from 0, no pain, to >6, intense pain, see citations) at baseline, during the procedure and at 5 and 60 minutes after the aspiration of respiratory secretions.
Both comparison of the score at the 4 study time-points and their variations between time-points will be analysed.
Measured: 1 hour
Sedation/agitation score during mechanical insufflation-exsufflation and hypertonic saline as assessed by a quantitative sedation/agitation system.
Comparative sedation/agitation score of the study procedures in the 4 study groups will be assessed using the RASS (Richmond Agitation-Sedation Scale, see citations), range -5, un-arousable, to +5, combative) at baseline, during the procedure and at 5 and 60 minutes after the aspiration of respiratory secretions.
Measured: 1 hour
Sedation/responsiveness score during mechanical insufflation-exsufflation and hypertonic saline as assessed by quantitative a sedation scoring system.
Comparative sedation/responsiveness score of the study procedures in the 4 study groups will be assessed using the responsiveness "Ramsay" Sedation Scale, range from 1, anxious and agitated, to 6, no response to stimulus, see citations) at baseline, during the procedure and at 5 and 60 minutes after the aspiration of respiratory secretions.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start1 Jun 2018
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Endotracheal TubeStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Randomized, four groups of different respiratory tract secretion suctioning methods: 1) catheter (conventional), 2) catheter after hypertonic saline, 3) mechanical insufflation-exsufflation, and 4) mechanical insufflation-exsufflation with hypertonic saline
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Chiesi España, Philips Respironics
- Responsible party
- Principal investigator, Miguel Sanchez Garcia, Hospital San Carlos, Madrid
- Investigators
- Miguel Sanchez Garcia, MD, PhD, Principal investigator, Hospital Clinico San Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940118
- Sponsor's protocol ID
- 18/253-R_X
- Acronym
- SMASH
- Status last verified
- May 2019
- First submitted
- 30 Dec 2018
- Last updated
- 8 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Latorre-Marco I, Acevedo-Nuevo M, Solis-Munoz M, Hernandez-Sanchez L, Lopez-Lopez C, Sanchez-Sanchez MM, Wojtysiak-Wojcicka M, de Las Pozas-Abril J, Robleda-Font G, Frade-Mera MJ, De Blas-Garcia R, Gorgolas-Ortiz C, De la Figuera-Bayon J, Cavia-Garcia C. Psychometric validation of the behavioral indicators of pain scale for the assessment of pain in mechanically ventilated and unable to self-report critical care patients. Med Intensiva. 2016 Nov;40(8):463-473. doi: 10.1016/j.medin.2016.06.004. Epub 2016 Aug 31. English, Spanish.
PubMed 27590592Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.
PubMed 12421743Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.
PubMed 4835444
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study on the Safety and Tolerability of Mechanical Insufflation-exsufflation and Hypertonic Saline With Hyaluronic Acid for Suctioning of Respiratory Tract Secretions in Patients With Artificial Airway
- ClinicalTrials.gov ID
- NCT03940118
- Acronym / sponsor ID
- SMASH / 18/253-R_X
- Conditions
- Endotracheal Tube, Tracheostomy
- Keywords
- respiratory secretion suctioning, mechanical insufflation exsufflation, hypertonic saline, hyaluronic acid, critically ill, artificial airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Collaborators
- Chiesi España, Philips Respironics
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 7 May 2019 (actual)
- 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.
Conventional catheter suctioning of respiratory tract secretions is a mandatory procedure in intubated patients. Poor tolerance, pain and other, sometimes severe, lung and cardiovascular complications may occur during suctioning.
Mechanical insufflation-exsufflation (MIE), coupled with hypertonic saline (HS), may improve efficacy airway clearance and reduce risk of the maneuver. However, safety of MIE and HS in intubated patients have not been studied appropriately, which justifies a randomized evaluation compared to conventional secretion suctioning.
Detailed description
Secretion suctioning (SS) in patients with artificial airway is a mandatory procedure, although occasionally painful, not tolerated and even causing traumatic injury to the respiratory mucosa.
Mechanical insufflation-exsufflation (MIE) and nebulized hypertonic saline with hyaluronic acid (HS-HA) have shown efficacy and safety in patients with chronic neuromuscular and pulmonary diseases, achieving aspiration and fluidification of respiratory secretions, respectively, as well as good tolerance.
Only anecdotal experience about the safety of MIE and HS-HA in critically ill patients with artificial airway and mechanical ventilation is available.
Background: Both MIE and HS-HA facilitate the drainage of secretions from the distal airway (compared to conventional catheter suctioning, the effect of which is supposed to be limited to the trachea) Both measures may prove to be efficacious in the prevention (through airway clearance of secretions) and concomitant treatment (reduction of inoculum or "draining the lung") of lower respiratory tract infections (tracheobronchitis and pneumonia).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- Randomized, four groups of different respiratory tract secretion suctioning methods: 1) catheter (conventional), 2) catheter after hypertonic saline, 3) mechanical insufflation-exsufflation, and 4) mechanical insufflation-exsufflation with hypertonic saline
| Arm | Type | Receives |
|---|---|---|
| Catheter secretion suctioning | Active comparator | Device: Catheter secretion suctioningSecretions are aspirated with a catheter at -120 to -150 mBar |
| Secretion suctioning + hypertonic saline | Experimental | Combination Product: Secretion suctioning + hypertonic salineHypertonic saline is nebulized prior to aspiration of secretions. |
| Ins-exsufflation | Experimental | Device: Ins-exsufflationMechanical insufflation-exsufflation with device programmed at 50/-50 mmHg |
| Ins-exsufflation + Hypertonic Saline | Experimental | Combination Product: Ins-exsufflation + Hypertonic salineMechanical insufflation-exsufflation and hypertonic saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Artificial airway ( endotracheal tube or tracheostomy cannula) with pressure cuff.
- Need for aspiration of secretions
- Informed consent
Key exclusion criteria (4 listed)
- Macroscopic hemoptysis.
- Acute bronchospasm
- Uncrontrolled muscular contractions, like tremor, myoclonus or other.
- Confirmed pregnancy
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 |
|---|---|---|
| Catheter secretion suctioningCatheter secretion suctioning with prior nebulization of hypertonic saline | Device | Catheter secretion suctioning |
| Secretion suctioning + hypertonic salineCatheter secretion suctioning with prior nebulization of hypertonic saline | Combination product | Secretion suctioning + hypertonic saline |
| Ins-exsufflationApplication of a mechanical insufflation-exsufflation device for respiratory tract secretion suctioning | Device | Ins-exsufflation |
| Ins-exsufflation + Hypertonic salineApplication of a mechanical insufflation-exsufflation device for respiratory tract secretion suctioning | Combination product | Ins-exsufflation + Hypertonic Saline |
Primary outcome
Aggregate cardiovascular and respiratory adverse events of mechanical insufflation-exsufflation and hypertonic saline.
Time frame: 1 hour
Comparative incidence of aggregate hemodynamic and respiratory adverse events. Adverse events criteria are predefined and will be expressed as: * Percentage of patients meeting aggregate predefined hemodynamic or respiratory adverse event criteria per study group. * Percentage of specific predefined adverse events (outcome variable "yes" or "no"): Desaturation (pulse-oximetry, >5%), hemoptisis (yes or no), bronchospasm (needing bronchodilator therapy), pneumothorax (as assessed by chest X-ray), hypotension (>30% or >10% increase in noradrenaline infusion from baseline), hypertension (>30% or >10% decrease in noradrenaline infusion from baseline), tachycardia (>90 bpm or >30% increase), bradycardia (<40 bpm), arrythmias (supra ventricular, requiring therapy), atelectasis (as assessed by chest X-ray), and other complications occuring during or within 1 hour after the procedure.
Pain score during mechanical insufflation-exsufflation and hypertonic saline as assessed by quantitative a pain scoring systems.
Time frame: 1 hour
Comparative pain scores of the study procedures in the 4 study groups will be assessed using the "ESCID" pain score (EScala de Conductas Indicadoras de Dolor, ranging from 0, no pain, to >6, intense pain, see citations) at baseline, during the procedure and at 5 and 60 minutes after the aspiration of respiratory secretions. Both comparison of the score at the 4 study time-points and their variations between time-points will be analysed.
Sedation/agitation score during mechanical insufflation-exsufflation and hypertonic saline as assessed by a quantitative sedation/agitation system.
Time frame: 1 hour
Comparative sedation/agitation score of the study procedures in the 4 study groups will be assessed using the RASS (Richmond Agitation-Sedation Scale, see citations), range -5, un-arousable, to +5, combative) at baseline, during the procedure and at 5 and 60 minutes after the aspiration of respiratory secretions.
Sedation/responsiveness score during mechanical insufflation-exsufflation and hypertonic saline as assessed by quantitative a sedation scoring system.
Time frame: 1 hour
Comparative sedation/responsiveness score of the study procedures in the 4 study groups will be assessed using the responsiveness "Ramsay" Sedation Scale, range from 1, anxious and agitated, to 6, no response to stimulus, see citations) at baseline, during the procedure and at 5 and 60 minutes after the aspiration of respiratory secretions.
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 8 May 2019.
- Background: PubMed 27590592Latorre-Marco I, Acevedo-Nuevo M, Solis-Munoz M, Hernandez-Sanchez L, Lopez-Lopez C, Sanchez-Sanchez MM, Wojtysiak-Wojcicka M, de Las Pozas-Abril J, Robleda-Font G, Frade-Mera MJ, De Blas-Garcia R, Gorgolas-Ortiz C, De la Figuera-Bayon J, Cavia-Garcia C. Psychometric validation of the behavioral indicators of pain scale for the assessment of pain in mechanically ventilated and unable to self-report critical care patients. Med Intensiva. 2016 Nov;40(8):463-473. doi: 10.1016/j.medin.2016.06.004. Epub 2016 Aug 31. English, Spanish.
- Background: PubMed 12421743Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.
- Background: PubMed 4835444Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.
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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.
Miguel Sanchez Garcia, MD, PhD principal investigator
Hospital Clinico San Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter secretion suctioning, Secretion suctioning + hypertonic saline and Ins-exsufflation in people with Endotracheal Tube and Tracheostomy, run by Hospital San Carlos, Madrid at 1 site in Spain.
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 3 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 8 May 2019. 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 Spain. 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. 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?
Aggregate cardiovascular and respiratory adverse events of mechanical insufflation-exsufflation and hypertonic saline. (time frame: 1 hour). The study lists 4 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 NCT03940118, which also lists 3 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 8 May 2019.