Mechanical Ventilation ComplicationNCT04061083
Effects of Endotracheal Tube Cuff Pressure Control on Microaspiration of Gastric Contents
A study testing Smart Cuff Manager and Manometer in people with Mechanical Ventilation Complication and Ventilator Associated Pneumonia, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of study is to determine effects of three different ET cuff pressure control on microaspiration of the stomach contents. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication, Ventilator Associated Pneumonia, Nursing Caries
- What is being tested?
- Smart Cuff Manager and Manometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 May 2019to 1 Dec 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
- Volunteering of the patient or relatives who will participate in the study,
- Patients who require mechanical ventilation support with endotracheal tube supply for 48 hours.
Who cannot join
- Patients who are contraindicated in giving a semi-fowler position,
- Patients with enteral nutrition contraindications,
- Patients connected to mechanical ventilators for more than 48 hours,
- Patients with tracheostomy,
- Patients admitted to ICU for gastroesophageal reflux disease, aspiration pneumonia or suspicion,
- Nasal endotracheal intubation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Three Endotracheal Tube Cuff Pressure Control on Microaspiration of Gastric Contents: a Randomized Controlled Trial
The purpose of study is to determine effects of three different ET cuff pressure control on microaspiration of the stomach contents.
Read the detailed description
In the study, ET cuff pressure control will be provided with pilot balloon fingers (Control Group), intermittent with a manometer (Study Group 1) and continuously with a smart cuff manager (Study Group 2).
To assess the effect of different ETT cuff pressure control on microaspiration of the stomach contents, the pepsin level will be measured during deep tracheal secretions. The samples will be examined in the first four hours after intubation, all secretions collected up to the 24th hour of intubation after first sample intake and all secretions collected between 24-48 hours after intubation. Pepsin level will be considered as positive for cut-off point. In addition, the effect of different ETT cuff pressures control on the incidence of VAP will be examined.
- Conditions
- Mechanical Ventilation Complication, Ventilator Associated Pneumonia, Nursing Caries, Aspiration, Respiratory
- Being tested
- Smart Cuff Manager, Manometer
- Keywords
- Intensive Care
- Medical subject headings
- Pneumonia, Ventilator-Associated, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Cuff ManagerDevice
Participant will be attached to the smart cuff manager within 4 hours after intubation. They will remain attached during the first 48 hours of intubation in the intensive care unit
ManometerDevice
Participant will be attached to the manometer within 4 hours after intubation. They will assess 3 times per day during the first 48 hours of intubation in the intensive care unit
| Study group | Role | What they receive |
|---|---|---|
| Continuous Endotracheal Cuff Pressure Control | Experimental | Continuous endotracheal cuff pressure control using smart cuff manager during the first 48 hours of intubation in the intensive care unit Receives: Device: Smart Cuff Manager |
| Intermittent Endotracheal Cuff Pressure Control | Experimental | Intermittent cuff pressure control through manual manometer measurement performed 3 times per day during the first 48 hours of intubation in the intensive care unit Receives: Device: Manometer |
| Standard Care | No intervention | ET cuff pressure control will be provided with pilot balloon fingers during the first 48 hours of intubation in the intensive care unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microaspiration of Gastric Contents
The unintentional aspiration of very small amounts of gastric contents
Measured: From randomisation to 48 hours after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start16 May 2019
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilation ComplicationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Özlem SOYER, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061083
- Sponsor's protocol ID
- 118S409
- Status last verified
- Feb 2023
- First submitted
- 15 Aug 2019
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Er OS, Van Giersbergen MY, Celik S. Effects of three endotracheal tube cuff pressure control measures on microaspiration of gastric content: Study protocol for randomised controlled trial. J Clin Nurs. 2023 Apr;32(7-8):1476-1486. doi: 10.1111/jocn.16493. Epub 2022 Aug 24.
PubMed 36002981
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Three Endotracheal Tube Cuff Pressure Control on Microaspiration of Gastric Contents: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04061083
- Acronym / sponsor ID
- 118S409
- Conditions
- Mechanical Ventilation Complication, Ventilator Associated Pneumonia, Nursing Caries, Aspiration, Respiratory
- Keywords
- Intensive Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 16 May 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 19 Aug 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.
The purpose of study is to determine effects of three different ET cuff pressure control on microaspiration of the stomach contents.
Detailed description
In the study, ET cuff pressure control will be provided with pilot balloon fingers (Control Group), intermittent with a manometer (Study Group 1) and continuously with a smart cuff manager (Study Group 2).
To assess the effect of different ETT cuff pressure control on microaspiration of the stomach contents, the pepsin level will be measured during deep tracheal secretions. The samples will be examined in the first four hours after intubation, all secretions collected up to the 24th hour of intubation after first sample intake and all secretions collected between 24-48 hours after intubation. Pepsin level will be considered as positive for cut-off point. In addition, the effect of different ETT cuff pressures control on the incidence of VAP will be examined.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continuous Endotracheal Cuff Pressure Control | Experimental | Device: Smart Cuff ManagerContinuous endotracheal cuff pressure control using smart cuff manager during the first 48 hours of intubation in the intensive care unit |
| Intermittent Endotracheal Cuff Pressure Control | Experimental | Device: ManometerIntermittent cuff pressure control through manual manometer measurement performed 3 times per day during the first 48 hours of intubation in the intensive care unit |
| Standard Care | No intervention | –ET cuff pressure control will be provided with pilot balloon fingers during the first 48 hours of intubation in the intensive care unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Volunteering of the patient or relatives who will participate in the study,
- Patients who require mechanical ventilation support with endotracheal tube supply for 48 hours.
Key exclusion criteria (6 listed)
- Patients who are contraindicated in giving a semi-fowler position,
- Patients with enteral nutrition contraindications,
- Patients connected to mechanical ventilators for more than 48 hours,
- Patients with tracheostomy,
- Patients admitted to ICU for gastroesophageal reflux disease, aspiration pneumonia or suspicion,
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 |
|---|---|---|
| Smart Cuff ManagerParticipant will be attached to the smart cuff manager within 4 hours after intubation. They will remain attached during the first 48 hours of intubation in the intensive care unit | Device | Continuous Endotracheal Cuff Pressure Control |
| ManometerParticipant will be attached to the manometer within 4 hours after intubation. They will assess 3 times per day during the first 48 hours of intubation in the intensive care unit | Device | Intermittent Endotracheal Cuff Pressure Control |
Primary outcome
Microaspiration of Gastric Contents
Time frame: From randomisation to 48 hours after intubation
The unintentional aspiration of very small amounts of gastric contents
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 Feb 2023.
- Derived from this study: PubMed 36002981Er OS, Van Giersbergen MY, Celik S. Effects of three endotracheal tube cuff pressure control measures on microaspiration of gastric content: Study protocol for randomised controlled trial. J Clin Nurs. 2023 Apr;32(7-8):1476-1486. doi: 10.1111/jocn.16493. Epub 2022 Aug 24.
- Individual participant dataSharing planned: No
Related trials for Mechanical Ventilation Complication
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Active, not recruitingObservational study
Potential Impact of the Use of the Application VentilO
Mechanical Ventilation Complication
Active, not recruitingObservational study
Evaluation of Gas Humidification Practices in Patients Under Invasive Mechanical Ventilation
Humidifier Lung, Mechanical Fragility
Active, not recruiting
VentilO Prospective Study
Mechanical Ventilation Complication, Respiratory Acidosis
Not yet recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
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 Smart Cuff Manager and Manometer in people with Mechanical Ventilation Complication and Ventilator Associated Pneumonia, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 8 Feb 2023. 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 Turkey (Türkiye). 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?
Microaspiration of Gastric Contents (time frame: From randomisation to 48 hours after intubation). 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 NCT04061083, which also lists 1 linked publication.
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 Feb 2023.