Ventilator Associated PneumoniaSPECIAL-ICUNCT06207513
Single-used Versus MultiPlE-used Endotracheal suCtIon cAtheters in Mechanically ventiLated ICU Patients
A study testing Suction Circuit Flushing with Chlorhexidine in people with Ventilator Associated Pneumonia, run by Mansoura University at 1 site in Egypt.
Trial summary
In low and middle-income countries, open endotracheal suction catheters are used multiple times to perform suctioning due to limited resources [1,2]. Currently, there is limited evidence for using a new suction catheter for each suction pass, acknowledged in a review article of endotracheal suction procedures in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- Suction Circuit Flushing with Chlorhexidine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2024to 31 Dec 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (aged ≥ 18 years old) who are admitted to the ICU, intubated with an endotracheal tube and receiving mechanical ventilation support directly after intubation with an expected mechanical ventilation support of at least 48 hours.
- All adults' patients meeting the above criteria whose relatives agree for them to be part of the study via deferred consent process
Who cannot join
- Patients who have received already standard care at ICU admission (the use of an endotracheal suction catheter multiple times during endotracheal suction procedures)
- Patients with contraindications to endotracheal suctioning procedure such as increased intracranial pressure, severe haemoptysis, and cerebrospinal fluid leaks.
- Patients who are previously intubated during the current hospital admission.
- Patients expected to receive mechanical ventilation less than 72 hours.
- Patients diagnosed with pneumonia at ICU admission.
- Patients having a Modified Clinical Pulmonary Infection Score (MCPIS) of 5 or greater.
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- Patients with atelectasis, ARDS, and pulmonary oedema.
- Patients known to be allergic to chlorhexidine.
- Patients whose family (next-of-kin) have not provided deferred consent within 48 hours after ICU admission will be excluded and standard care will be provided.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-used Versus MultiPlE-used Endotracheal suCtIon cAtheters in Mechanically ventiLated ICU Patients: the SPECIAL-ICU Trial
In low and middle-income countries, open endotracheal suction catheters are used multiple times to perform suctioning due to limited resources [1,2]. Currently, there is limited evidence for using a new suction catheter for each suction pass, acknowledged in a review article of endotracheal suction procedures in paediatric populations [3]. Additionally, the latest artificial airway suctioning practice guidelines published by the American Association for Respiratory Care in 2022 did not mention any recommendations regarding suction catheter changing frequency [4]. The guidelines adopted a study conducted in 2001 which showed that reusing an open tracheal suctioning catheter is safe and cost effective [5]. Therefore, the current evidence of reusing suctioning catheters remains unclear, which rationalize the reason why some resource limited Intensive Care Units (ICUs) use the catheter multiple times during a 12-hour shift, and possibly explain the high ventilator associated pneumonia (VAP) incidence in these ICUs [1,2].
Therefore, this feasibility study will propose to explore whether single-used suction catheters or multiple used open endotracheal tracheal suctioning catheters flushed with chlorhexidine are associated with reduced VAP incidence and its impact on mechanically ventilated patients.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- Suction Circuit Flushing with Chlorhexidine
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suction Circuit Flushing with ChlorhexidineProcedure or surgery
Patient intubated with an endotracheal tube and on a mechanical ventilator will receive endotracheal suctioning procedure using an open endotracheal suction catheter that is used multiple times during a 12-hour nursing shift. Flushing of the suctioning circuit will be performed with 40 ml of chlorhexidine gluconate 0.2% after every endotracheal suction procedure
| Study group | Role | What they receive |
|---|---|---|
| Intervention I group | Experimental | Patient intubated with an endotracheal tube and on a mechanical ventilator will receive endotracheal suctioning procedure using a single-used open endotracheal suction catheter that is used only for one-time suctioning attempt and discarded after each endotracheal suction cycle. A new catheter will be used for each endotracheal suctioning procedure. Receives: Procedure: Suction Circuit Flushing with Chlorhexidine |
| Intervention II group | Experimental | Patient intubated with an endotracheal tube and on a mechanical ventilator will receive endotracheal suctioning procedure using an open endotracheal suction catheter that is used multiple times during a 12-hour nursing shift. Flushing of the suctioning circuit will be performed with 40 ml of chlorhexidine gluconate 0.2% after every endotracheal suction procedure Receives: Procedure: Suction Circuit Flushing with Chlorhexidine |
| Control group | Other | Patients intubated with an endotracheal tube and on a mechanical ventilator will receive standard care. This is the endotracheal suctioning procedure using an open endotracheal suction catheter that is used multiple times during a 12-hour nursing shift. Flushing of the suctioning circuit is standardised performed using normal saline after every endotracheal suction procedure. Receives: Procedure: Suction Circuit Flushing with Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of intervention
The feasibility and acceptability of the proposed intervention among healthcare professionals in study settings and determine methods for the design of a conclusive randomized controlled trial.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Patients outcome
Will measure the impact of the proposed intervention on mechanically patients outcomes including Ventilator associated pneumonia incidence (using the modified clinical pulmonary infection score) and length of ICU stay
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start15 Apr 2024
- Primary completion30 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Plymouth
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207513
- Sponsor's protocol ID
- 4112023
- Acronym
- SPECIAL-ICU
- Status last verified
- Jun 2024
- First submitted
- 18 Dec 2023
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Eid MH, Hambridge K, Schofield P, Latour JM. Nurses' and Families' Experiences of a Feasibility Trial Comparing Single-Use and Multiple-Use Endotracheal Suction Catheters in Mechanically Ventilated Patients: A Qualitative Study. Nurs Crit Care. 2026 Sep;31(5):e70624. doi: 10.1111/nicc.70624.
PubMed 42591052Eid MH, Hambridge K, Schofield P, Latour JM. Single-Use Versus Multiple-Use Endotracheal Suction Catheters in Mechanically Ventilated Patients: A Feasibility Randomised Controlled Trial. Nurs Crit Care. 2026 Jan;31(1):e70237. doi: 10.1111/nicc.70237.
PubMed 41501433
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-used Versus MultiPlE-used Endotracheal suCtIon cAtheters in Mechanically ventiLated ICU Patients: the SPECIAL-ICU Trial
- ClinicalTrials.gov ID
- NCT06207513
- Acronym / sponsor ID
- SPECIAL-ICU / 4112023
- Conditions
- Ventilator Associated Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Collaborators
- University of Plymouth
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 17 Jan 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.
In low and middle-income countries, open endotracheal suction catheters are used multiple times to perform suctioning due to limited resources [1,2]. Currently, there is limited evidence for using a new suction catheter for each suction pass, acknowledged in a review article of endotracheal suction procedures in paediatric populations [3]. Additionally, the latest artificial airway suctioning practice guidelines published by the American Association for Respiratory Care in 2022 did not mention any recommendations regarding suction catheter changing frequency [4]. The guidelines adopted a study conducted in 2001 which showed that reusing an open tracheal suctioning catheter is safe and cost effective [5]. Therefore, the current evidence of reusing suctioning catheters remains unclear, which rationalize the reason why some resource limited Intensive Care Units (ICUs) use the catheter multiple times during a 12-hour shift, and possibly explain the high ventilator associated pneumonia (VAP) incidence in these ICUs [1,2].
Therefore, this feasibility study will propose to explore whether single-used suction catheters or multiple used open endotracheal tracheal suctioning catheters flushed with chlorhexidine are associated with reduced VAP incidence and its impact on mechanically ventilated patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention I group | Experimental | Procedure: Suction Circuit Flushing with ChlorhexidinePatient intubated with an endotracheal tube and on a mechanical ventilator will receive endotracheal suctioning procedure using a single-used open endotracheal suction catheter that is used only for one-time suctioning attempt and discarded after each endotracheal suction cycle. A new catheter will be used for each endotracheal suctioning procedure. |
| Intervention II group | Experimental | Procedure: Suction Circuit Flushing with ChlorhexidinePatient intubated with an endotracheal tube and on a mechanical ventilator will receive endotracheal suctioning procedure using an open endotracheal suction catheter that is used multiple times during a 12-hour nursing shift. Flushing of the suctioning circuit will be performed with 40 ml of chlorhexidine gluconate 0.2% after every endotracheal suction procedure |
| Control group | Other | Procedure: Suction Circuit Flushing with ChlorhexidinePatients intubated with an endotracheal tube and on a mechanical ventilator will receive standard care. This is the endotracheal suctioning procedure using an open endotracheal suction catheter that is used multiple times during a 12-hour nursing shift. Flushing of the suctioning circuit is standardised performed using normal saline after every endotracheal suction procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (aged ≥ 18 years old) who are admitted to the ICU, intubated with an endotracheal tube and receiving mechanical ventilation support directly after intubation with an expected mechanical ventilation support of at least 48 hours.
- All adults' patients meeting the above criteria whose relatives agree for them to be part of the study via deferred consent process
Key exclusion criteria (9 listed)
- Patients who have received already standard care at ICU admission (the use of an endotracheal suction catheter multiple times during endotracheal suction procedures)
- Patients with contraindications to endotracheal suctioning procedure such as increased intracranial pressure, severe haemoptysis, and cerebrospinal fluid leaks.
- Patients who are previously intubated during the current hospital admission.
- Patients expected to receive mechanical ventilation less than 72 hours.
- Patients diagnosed with pneumonia at ICU admission.
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 |
|---|---|---|
| Suction Circuit Flushing with ChlorhexidinePatient intubated with an endotracheal tube and on a mechanical ventilator will receive endotracheal suctioning procedure using an open endotracheal suction catheter that is used multiple times during a 12-hour nursing shift. Flushing of the suctioning circuit will be performed with 40 ml of chlorhexidine gluconate 0.2% after every endotracheal suction procedure | Procedure or surgery | Control group, Intervention I group, Intervention II group |
Primary outcome
Feasibility of intervention
Time frame: through study completion, an average of 1 year
The feasibility and acceptability of the proposed intervention among healthcare professionals in study settings and determine methods for the design of a conclusive randomized controlled trial.
1 secondary outcome
Patients outcome
Time frame: through study completion, an average of 1 year
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 3 Jan 2025.
- Derived from this study: PubMed 42591052Eid MH, Hambridge K, Schofield P, Latour JM. Nurses' and Families' Experiences of a Feasibility Trial Comparing Single-Use and Multiple-Use Endotracheal Suction Catheters in Mechanically Ventilated Patients: A Qualitative Study. Nurs Crit Care. 2026 Sep;31(5):e70624. doi: 10.1111/nicc.70624.
- Derived from this study: PubMed 41501433Eid MH, Hambridge K, Schofield P, Latour JM. Single-Use Versus Multiple-Use Endotracheal Suction Catheters in Mechanically Ventilated Patients: A Feasibility Randomised Controlled Trial. Nurs Crit Care. 2026 Jan;31(1):e70237. doi: 10.1111/nicc.70237.
- Individual participant dataSharing planned: Undecided
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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 Suction Circuit Flushing with Chlorhexidine in people with Ventilator Associated Pneumonia, run by Mansoura University at 1 site in Egypt.
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 2 inclusion and 9 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 3 Jan 2025. 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 Egypt. 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?
Feasibility of intervention (time frame: through study completion, an average of 1 year). 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 NCT06207513, which also lists 2 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 3 Jan 2025.