A comparison of two devices to measure the endotracheal tube (ETT) cuff pressure in intubated patients
| ISRCTN | ISRCTN17981371 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17981371 |
- Submission date
- 06/12/2020
- Registration date
- 09/12/2020
- Last edited
- 09/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
An endotracheal tube (ETT) is a flexible plastic tube that is placed through the mouth into the trachea (windpipe) to help a patient breathe. The endotracheal tube is then connected to a ventilator, which delivers oxygen to the lungs. The process of inserting the tube is called endotracheal intubation. The cuff is designed to provide a seal with the airway, allowing airflow through the ETT but preventing passage of air or fluids around the ETT.
Monitoring and maintaining ETT cuff pressure in a reasonable range is of great significance in clinical practice force as well as a challenge.
This study compared the effect of a manual cuff pressure gauge and disposable pressure transducer in the monitoring of ETT cuff pressure
Who can participate?
Patients requiring intubation for mechanical ventilation (assisted breathing) for over 48 hours.
What does the study involve?
Patients were randomly divided into the control group and the test group. In the control group, ETT cuff pressure was measured using the ETT manual cuff pressure gauge; while in the test group the disposable pressure transducer was used. Measurements were taken every 4 hours.
What are the possible benefits and risks of participating?
None
Where is the study run from?
The Third the People's Hospital of Bengbu (China)
When is the study starting and how long is it expected to run for?
Who is funding the study?
The Third the People's Hospital of Bengbu (China)
Who is the main contact?
Xin Lin, 798431769@qq.com
Contact information
Scientific
Department of Intensive Care Unit
The Third People's Hospital of Bengbu
Shengli 38 street of Bengbu
Bengbu
233000
China
| Phone | +86 15155298893 |
|---|---|
| 798431769@qq.com |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | The effect of manual cuff pressure gauge and disposable pressure transducer in the monitoring of endotracheal tube (ETT) cuff pressure in artificial airway patients and the compliance of nurses to measure ETT cuff pressure |
| Study objectives | Compared with intermittent Endotracheal tube (ETT) cuff pressure monitoring with manual cuff pressure gauge, continuous ETT cuff pressure monitoring with a disposable pressure transducer can dynamically monitor pressure changes on the basis of ensuring good monitoring effect to reduce the workload of nurses, improve the compliance of nurses, and better improve the qualified rate of ETT cuff pressure monitoring in artificial airway patients. |
| Ethics approval(s) | Approved 22/10/2018, Ethics Committee of The Third People's Hospital of Bengbu (38 Shengli Street, Bengbu, Anhui, China; +86 (0)552-2051760; hulibu123456@163.com), ref: BBSY-2018.44 |
| Health condition(s) or problem(s) studied | Endotracheal tube (ETT) cuff pressure in intubated patients |
| Intervention | Patients were divided into the control group and test group, using a computerized random number generator by a trial statistician who had no clinical involvement in the project. In the control group ETT cuff pressure was measured using the ETT manual cuff pressure gauge; while in the test group the disposable pressure transducer was used. Measurements included the ETT cuff pressure level, the average air leakage of the cuff, the number of patients of ventilator leakage alarm, the number of patients with Ventilator-Associated Pneumonia (VAP) and the compliance of bedside nurses to monitor and adjust the ETT cuff pressure. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | German VBM ETT manual cuff pressure gauge, USA OHMEDA ECG monitor, disposable pressure transducer and its accessories |
| Primary outcome measure | ETT cuff pressure measured by nursing staff in the ICU every four hours using the devices under investigation |
| Secondary outcome measures | 1. Air leakage of cuff (the difference between the pressure after the last cuff recharge and the next) measured every four hours 2.The number of ventilator leakage alarms measured by checking the alarm records on the ventilators every four hours 3. The number of patients with Ventilator-Associated Pneumonia (VAP) whilst in hospital measured using data from the hospital infection management department 4. The compliance of bedside nurses to monitor and adjust ETT cuff pressure measured by analysis of daily bedside video |
| Overall study start date | 15/10/2018 |
| Completion date | 30/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 104 |
| Total final enrolment | 104 |
| Key inclusion criteria | 1. Mechanical ventilation in patients with tracheal intubation 2. Age of patients ≥18 years 3. Mechanical ventilation time >48 hours 4. ETT from the same manufacturer, model 8＃,7.5＃, or 7＃, and using high volume low-pressure cuff (HVLP) 5. informed consent of patients or family members , and willing to participate in this study |
| Key exclusion criteria | 1. Patients with airway malformation, airway stenosis 2. Patients with trachea and esophagus leak or cuff leak 3. Patients with pulmonary infection before trachea cannula 4. Patients with tracheotomy 5. Patients being involved with other researchers |
| Date of first enrolment | 01/07/2019 |
| Date of final enrolment | 30/11/2019 |
Locations
Countries of recruitment
- China
Study participating centre
Bengbu
233000
China
Sponsor information
Hospital/treatment centre
Shengli 38 Street of Bengbu
Bengbu
233000
China
| Phone | +86 (0)552-2051760 |
|---|---|
| hulibu123456@163.com |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/02/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to confidentiality. |
Editorial Notes
09/12/2020: Trial’s existence confirmed by Ethics Committee of The Third People's Hospital of Bengbu.
