Nosocomial InfectionABSENTANCT06310941
Mechanical Insufflation-exsufflation and Hypertonic Saline in Nosocomial Bacterial Respiratory Tract Infection
A study testing Mechanical insufflation-exsufflation and Hypertonic saline with hyaluronic acid in people with Nosocomial Infection and Nosocomial Pneumonia, run by Hospital San Carlos, Madrid at 8 sites in Spain.
Trial summary
Multicenter, randomized open label clinical trial to evaluate IEM and HS as concomitant therapy for respiratory tract infection in patients under artificial ventilation in the ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nosocomial Infection, Nosocomial Pneumonia, Tracheobronchitis
- What is being tested?
- Mechanical insufflation-exsufflation and Hypertonic saline with hyaluronic acid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 8 sitesSpain
- Study dates
- 1 Jan 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Signed informed consent
- Nosocomial pneumonia (vHAP or VAP) or nosocomial tracheobronchitis
- Intubated with a cuffed endotracheal tube or tracheostomy cannula.
Who cannot join
- Ominous prognosis
- Frank hemoptisis
- Barotrauma (pneumothorax or pneumomediastinum)
- Bronchospasm (patients on bronchodilators for previous bronchospasm may be included
- Unstable thoracic cage
- Suspected unmonitored intracraneal hypertension
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Spain8 sites
Hospital Vall d´Hebrón.
Barcelona, Barcelona
Xavier - Nuvials, MD, PhD
Ricard - Ferrer Roca, MD, PhD
Hospital Clinico San Carlos
Madrid, Madrid, 28040
Miguel Sanchez-Garcia, 658762739, miguelsanchez.hcsc@gmail.com
Fernando Martínez-Sagasti, MD
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Miguel Sanchez-Garcia, MD, PhD, +34658762739, miguelsanchez.hcsc@gmail.com
Belén De la Hera Hernanz, PhD, belenhhernanz@gmail.com
Hospital de la Princesa
Madrid, Madrid
Aris - Pérez Lucendo
Dolores - Rodríguez Huerta
Hospital Doce de Octubre
Madrid, Madrid
María Cruz - Martín-Delgado, MD
Mercedes Catalán, MD
Hospital Nuestra Señora de la Candelaria.
Santa Cruz de Tenerife, Las Palmas
Sergio - Rodríguez Ramos, MD
Virgen de la Salud
Toledo, Toledo
Gonzalo Hernández, MD, PhD
Hospital Álvaro Cunqueiro.
Vigo, Pontevedra
Pilar Losada, MD, PhD
Dolores Vila, MD, PhD
About this study
Official title: Aspiration of Bronchial Secretions With Mechanical Insufflation-Exsufflation and Hypertonic Saline in Bacterial Nosocomial Tracheobronchitis and Pneumonia in Intubated Patients.
Multicenter, randomized open label clinical trial to evaluate IEM and HS as concomitant therapy for respiratory tract infection in patients under artificial ventilation in the ICU.
Lung infection is a serious complication that may occur during hospital stay and may need artificial respiration or even develop during artificial ventilation for other causes.
Current specific treatment consists of intravenous antibiotics. The current study evaluated whether aspiration and drainage of infected sputum helps curing this severe complication and whether nebulized HS has additional benefits, like loosening of secretions, eradicating bacteria or reducing inflammation.
Read the detailed description
Open label, randomized, multicenter (7 ICUs at 7 hospitals in Spain). The study has 2 main arms, pneumonia and tracheobronchitis.
If the diagnosis is pneumonia, subjects will be randomization to one of 3 study groups:
- IV Antibiotic therapy
- IV Antibiotic therapy + mechanical insufflation-Exsugglation (MI-E)
- IV Antibiotic therapy + MI-E + nebulized hypertonic saline-hyaluronic acid (HS)
If the diagnosis is tracheobronchitis,subjects will be randomization to one of 3 study groups:
- No specific therapy (recommendation of the Infectious Diseases Society of America)
- IV Antibiotic therapy (common practice to prevent progressión to pneumona and shorten duration of intubation)
- MI-E + HS
Safety will be compared by number of adverse events, severe adverse events and mortality between study groups in each main arm. Efficacy will be compared by duration of respiratory support and number of cases with worsening organ dysfunction.
- Conditions
- Nosocomial Infection, Nosocomial Pneumonia, Tracheobronchitis, Mechanical Ventilation Complication, Endotracheal Intubation
- Being tested
- Mechanical insufflation-exsufflation, Standard of Care, Hypertonic saline with hyaluronic acid
- Keywords
- mechanical insufflation-exsufflation, cough assist device, hypertonic saline, nosocomial respiratory tract infection, hospital-acquired pneumonia, tracheobronchitis, ventilator-associated pneumonia, nebulization
- Medical subject headings
- Cross Infection, Healthcare-Associated Pneumonia, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical insufflation-exsufflationDevice
Also called Cough Assist
Combined use of mechanical insufflation-exsufflation with nebulized hypertonic saline in intubated patients with nosocomial respiratory tract infection
Standard of CareOther
Also called Routine care of respiratory tract infection
systemic antibiotic therapy and catheter suctioning of secretions as recommended by guidelines
Hypertonic saline with hyaluronic acidOther
Also called (Hyaneb-TM)
Commercially available combination of 7% hypertonic saline with 0.1% hyaluronic acid given as nebulization during the MI-E session
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Standard of care: Systemic antibiotic therapy according to local protocol and at the discretion of the attending intensivist. Receives: Other: Standard of Care |
| Mechanical insufflation-exsufflation with hypertonic saline/hyaluronic acid comination | Experimental | Systemic antibiotic therapy choice according to local protocol and at the discretion of the attending intensivist plus Mechanical insufflation-exsufflation (MI-E sessión tid during the first 48 hours, followed by MI-E if secretions are present or suspected; recommended settings +50 cmH2O/-50 cmH2O) with simultaneous nebulization of hypertonic saline (7%) with hyaluronic acid (0.1%). Receives: Device: Mechanical insufflation-exsufflation; Other: Hypertonic saline with hyaluronic acid |
| Mechanical insufflation-exsufflation | Experimental | Systemic antibiotic therapy choice according to local protocol and at the discretion of the attending intensivist plus Mechanical insufflation-exsufflation (MI-E sessión tid during the first 48 hours, followed by MI-E if secretions are present or suspected; recommended settings +50 cmH2O/-50 cmH2O) Receives: Device: Mechanical insufflation-exsufflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median SOFA score increase >2 points on day 4
Increase in organ dysfunction score from baseline to day 4 after randomization.
Measured: inclusion to day 4 after randomization
Median respiratory support-free days increase at day 28
28 minus duration in days on high-flow nasal cannula + invasive ventilation.
Measured: Inclusion to day 28 after randomization
Percentage of subjects surviving/dying day 28
crude mortality on day 28 after randomization
Measured: Inclusion to day 28 after randomization
Secondary outcomes (4)
Subjects with bacterial eradication in respiratory samples at day 4 after randomization
Negative tests for causal microorganism in day 4 samples
Measured: Day 3 to 5 after randomization
Subjects with bacterial eradication in respiratory samples at end of systemic antibiotic therapy
Negative culture and molecular test for causative bacteria in samples at end of therapy
Measured: 7 and 14 days after randomization
Median Length of ICU stay
Duration of ICU stay from admission to discharge or death
Measured: ICU admission to discharge or death in days
Median antibiotic-free days at 28 days
28 minus days without systemic antibiotic therapy
Measured: from study inclusion to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Jan 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nosocomial InfectionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicenter, randomized, open label
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS
- Responsible party
- Principal investigator, Miguel Sanchez Garcia, Hospital San Carlos, Madrid
- Investigators
- Belén De la Hera Hernanz, PhD, Study director, Hospial Clinico San Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310941
- Sponsor's protocol ID
- ABSENTA
- Other IDs
- Pending
- Acronym
- ABSENTA
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymyzed data sheet of all subjects and variables for a pre-specified analysis plan.
Publications
Ferreira de Camillis ML, Savi A, Goulart Rosa R, Figueiredo M, Wickert R, Borges LGA, Galant L, Teixeira C. Effects of Mechanical Insufflation-Exsufflation on Airway Mucus Clearance Among Mechanically Ventilated ICU Subjects. Respir Care. 2018 Dec;63(12):1471-1477. doi: 10.4187/respcare.06253. Epub 2018 Jul 17.
PubMed 30018175Knudtzen FC, Sprehn M, Vestbo J, Johansen IS. Mechanical insufflation/exsufflation compared with standard of care in patients with pneumonia: A randomised controlled trial. Eur J Anaesthesiol. 2020 Nov;37(11):1077-1080. doi: 10.1097/EJA.0000000000001209. No abstract available.
PubMed 33027229Sanchez-Garcia M, Santos P, Rodriguez-Trigo G, Martinez-Sagasti F, Farina-Gonzalez T, Del Pino-Ramirez A, Cardenal-Sanchez C, Busto-Gonzalez B, Requesens-Solera M, Nieto-Cabrera M, Romero-Romero F, Nunez-Reiz A. Preliminary experience on the safety and tolerability of mechanical "insufflation-exsufflation" in subjects with artificial airway. Intensive Care Med Exp. 2018 Apr 3;6(1):8. doi: 10.1186/s40635-018-0173-6.
PubMed 29616357Sanchez-Garcia M, Alvarez-Gonzalez M, Domingo-Marin S, Pino-Ramirez AD, Martinez-Sagasti F, Gonzalez-Arenas P, Cardenal-Sanchez C, Velasco-Lopez E, Nunez-Reiz A. Comparison of Mechanical Insufflation-Exsufflation and Hypertonic Saline and Hyaluronic Acid With Conventional Open Catheter Suctioning in Intubated Patients. Respir Care. 2024 Apr 22;69(5):575-585. doi: 10.4187/respcare.11566.
PubMed 38307525
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspiration of Bronchial Secretions With Mechanical Insufflation-Exsufflation and Hypertonic Saline in Bacterial Nosocomial Tracheobronchitis and Pneumonia in Intubated Patients.
- ClinicalTrials.gov ID
- NCT06310941
- Acronym / sponsor ID
- ABSENTA / ABSENTA
- Conditions
- Nosocomial Infection, Nosocomial Pneumonia, Tracheobronchitis, Mechanical Ventilation Complication, Endotracheal Intubation
- Keywords
- mechanical insufflation-exsufflation, cough assist device, hypertonic saline, nosocomial respiratory tract infection, hospital-acquired pneumonia, tracheobronchitis, ventilator-associated pneumonia, nebulization
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Collaborators
- FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 15 Mar 2024 (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.
Multicenter, randomized open label clinical trial to evaluate IEM and HS as concomitant therapy for respiratory tract infection in patients under artificial ventilation in the ICU.
Lung infection is a serious complication that may occur during hospital stay and may need artificial respiration or even develop during artificial ventilation for other causes.
Current specific treatment consists of intravenous antibiotics. The current study evaluated whether aspiration and drainage of infected sputum helps curing this severe complication and whether nebulized HS has additional benefits, like loosening of secretions, eradicating bacteria or reducing inflammation.
Detailed description
Open label, randomized, multicenter (7 ICUs at 7 hospitals in Spain). The study has 2 main arms, pneumonia and tracheobronchitis.
If the diagnosis is pneumonia, subjects will be randomization to one of 3 study groups:
- IV Antibiotic therapy
- IV Antibiotic therapy + mechanical insufflation-Exsugglation (MI-E)
- IV Antibiotic therapy + MI-E + nebulized hypertonic saline-hyaluronic acid (HS)
If the diagnosis is tracheobronchitis,subjects will be randomization to one of 3 study groups:
- No specific therapy (recommendation of the Infectious Diseases Society of America)
- IV Antibiotic therapy (common practice to prevent progressión to pneumona and shorten duration of intubation)
- MI-E + HS
Safety will be compared by number of adverse events, severe adverse events and mortality between study groups in each main arm. Efficacy will be compared by duration of respiratory support and number of cases with worsening organ dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- multicenter, randomized, open label
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Standard of CareStandard of care: Systemic antibiotic therapy according to local protocol and at the discretion of the attending intensivist. |
| Mechanical insufflation-exsufflation with hypertonic saline/hyaluronic acid comination | Experimental | Device: Mechanical insufflation-exsufflation, Other: Hypertonic saline with hyaluronic acidSystemic antibiotic therapy choice according to local protocol and at the discretion of the attending intensivist plus Mechanical insufflation-exsufflation (MI-E sessión tid during the first 48 hours, followed by MI-E if secretions are present or suspected; recommended settings +50 cmH2O/-50 cmH2O) with simultaneous nebulization of hypertonic saline (7%) with hyaluronic acid (0.1%). |
| Mechanical insufflation-exsufflation | Experimental | Device: Mechanical insufflation-exsufflationSystemic antibiotic therapy choice according to local protocol and at the discretion of the attending intensivist plus Mechanical insufflation-exsufflation (MI-E sessión tid during the first 48 hours, followed by MI-E if secretions are present or suspected; recommended settings +50 cmH2O/-50 cmH2O) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed informed consent
- Nosocomial pneumonia (vHAP or VAP) or nosocomial tracheobronchitis
- Intubated with a cuffed endotracheal tube or tracheostomy cannula.
Key exclusion criteria (6 listed)
- Ominous prognosis
- Frank hemoptisis
- Barotrauma (pneumothorax or pneumomediastinum)
- Bronchospasm (patients on bronchodilators for previous bronchospasm may be included
- Unstable thoracic cage
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 |
|---|---|---|
| Mechanical insufflation-exsufflationAlso: Cough AssistCombined use of mechanical insufflation-exsufflation with nebulized hypertonic saline in intubated patients with nosocomial respiratory tract infection | Device | Mechanical insufflation-exsufflation, Mechanical insufflation-exsufflation with hypertonic saline/hyaluronic acid comination |
| Standard of CareAlso: Routine care of respiratory tract infectionsystemic antibiotic therapy and catheter suctioning of secretions as recommended by guidelines | Other | Standard of Care |
| Hypertonic saline with hyaluronic acidAlso: (Hyaneb-TM)Commercially available combination of 7% hypertonic saline with 0.1% hyaluronic acid given as nebulization during the MI-E session | Other | Mechanical insufflation-exsufflation with hypertonic saline/hyaluronic acid comination |
Primary outcome
Median SOFA score increase >2 points on day 4
Time frame: inclusion to day 4 after randomization
Increase in organ dysfunction score from baseline to day 4 after randomization.
Median respiratory support-free days increase at day 28
Time frame: Inclusion to day 28 after randomization
28 minus duration in days on high-flow nasal cannula + invasive ventilation.
Percentage of subjects surviving/dying day 28
Time frame: Inclusion to day 28 after randomization
crude mortality on day 28 after randomization
4 secondary outcomes
Subjects with bacterial eradication in respiratory samples at day 4 after randomization
Time frame: Day 3 to 5 after randomization
Subjects with bacterial eradication in respiratory samples at end of systemic antibiotic therapy
Time frame: 7 and 14 days after randomization
Median Length of ICU stay
Time frame: ICU admission to discharge or death in days
Median antibiotic-free days at 28 days
Time frame: from study inclusion to day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Background: PubMed 30018175Ferreira de Camillis ML, Savi A, Goulart Rosa R, Figueiredo M, Wickert R, Borges LGA, Galant L, Teixeira C. Effects of Mechanical Insufflation-Exsufflation on Airway Mucus Clearance Among Mechanically Ventilated ICU Subjects. Respir Care. 2018 Dec;63(12):1471-1477. doi: 10.4187/respcare.06253. Epub 2018 Jul 17.
- Background: PubMed 33027229Knudtzen FC, Sprehn M, Vestbo J, Johansen IS. Mechanical insufflation/exsufflation compared with standard of care in patients with pneumonia: A randomised controlled trial. Eur J Anaesthesiol. 2020 Nov;37(11):1077-1080. doi: 10.1097/EJA.0000000000001209. No abstract available.
- Background: PubMed 29616357Sanchez-Garcia M, Santos P, Rodriguez-Trigo G, Martinez-Sagasti F, Farina-Gonzalez T, Del Pino-Ramirez A, Cardenal-Sanchez C, Busto-Gonzalez B, Requesens-Solera M, Nieto-Cabrera M, Romero-Romero F, Nunez-Reiz A. Preliminary experience on the safety and tolerability of mechanical "insufflation-exsufflation" in subjects with artificial airway. Intensive Care Med Exp. 2018 Apr 3;6(1):8. doi: 10.1186/s40635-018-0173-6.
- Results publication: PubMed 38307525Sanchez-Garcia M, Alvarez-Gonzalez M, Domingo-Marin S, Pino-Ramirez AD, Martinez-Sagasti F, Gonzalez-Arenas P, Cardenal-Sanchez C, Velasco-Lopez E, Nunez-Reiz A. Comparison of Mechanical Insufflation-Exsufflation and Hypertonic Saline and Hyaluronic Acid With Conventional Open Catheter Suctioning in Intubated Patients. Respir Care. 2024 Apr 22;69(5):575-585. doi: 10.4187/respcare.11566.
- Individual participant dataSharing planned: Yes. Anonymyzed data sheet of all subjects and variables for a pre-specified analysis plan.
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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.
Belén De la Hera Hernanz, PhD study director
Hospial Clinico San Carlos
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical insufflation-exsufflation and Hypertonic saline with hyaluronic acid in people with Nosocomial Infection and Nosocomial Pneumonia, run by Hospital San Carlos, Madrid at 8 sites 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 6 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: opening soon, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miguel Sánchez Garcia, MD. PhD. (+34658762739, miguelsanchez.hcsc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median SOFA score increase >2 points on day 4 (time frame: inclusion to day 4 after randomization). The study lists 3 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 NCT06310941, which also lists 4 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 Mar 2025.