Application of threaded tube in atomisation inhalation
| ISRCTN | ISRCTN73052288 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73052288 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Second Hospital of Hebei Medical University |
| Funder | Second Hospital of Hebei Medical University |
- Submission date
- 08/10/2024
- Registration date
- 31/10/2024
- Last edited
- 30/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
In the case of a dry airway, viscous sputum and tracheal intubation easily lead to an increased chance of pulmonary infection in patients. However, at present, the atomization device used to moisten the airway cannot be connected to the mouth end of tracheal intubation, which causes liquid waste during drug atomization inhalation, resulting in insufficient atomization. This study aims to observe the effect of the combined use of threaded tubes and traditional atomisation devices on atomisation inhalation in patients.
Who can participate?
Comatose patients undergoing non-mechanical tracheal ventilation
What does the study involve?
Through convenience sampling, this study enrolled patients undergoing non-mechanical ventilation with endotracheal intubation admitted to the Neurosurgery Department of the Second Hospital of Hebei Medical University between March 2020 and September 2023. The included patients were divided into two groups: the experimental group and the control group. The experimental group was provided with threaded tubes and traditional atomization devices for inhalation, while the control group received only traditional atomization devices.
What are the possible benefits and risks of participating?
Combining threaded tubes and traditional atomisation devices in patients undergoing non-mechanical ventilation with endotracheal intubation may offer potential benefits for airway management and respiratory health.
No risks provided at publication.
Where is the study run from?
The Second Hospital of Hebei Medical University
When is the study starting and how long is it expected to run for?
March 2020 to September 2023
Who is funding the study?
Second Hospital of Hebei Medical University
Who is the main contact?
Dr Liqiao Zhang, liqiao_zhang@126.com
Contact information
Public, Scientific, Principal investigator
Second Hospital of Hebei Medical University, No.215 Heping West Road
Shijiazhuang City
050000
China
 ORCID ID |
0009-0009-9496-0873 |
|---|---|
| Phone | +86 0311-66002999 |
| liqiao_zhang@126.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomized study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Application of threaded tube in atomisation inhalation for patients undergoing non-mechanical ventilation with endotracheal intubation |
| Study objectives | To observe the effect of the combined use of threaded tubes and traditional atomisation devices on atomisation inhalation in patients. |
| Ethics approval(s) |
Approved 02/03/2020, Research Ethics Committee of the Second Hospital of Hebei Medical University (No.215 Heping West Road, Shijiazhuang City, 050000, China; +86 0311 66002811; ydeyjf@126.com), ref: 2020-R073 |
| Health condition(s) or problem(s) studied | Atomisation inhalation for patients undergoing non-mechanical ventilation with endotracheal intubation |
| Intervention | Comatose patients undergoing non-mechanical tracheal ventilation were included and divided into two groups: the experimental group (n = 56) and the control group (n = 49). The experimental group was provided with a combination of threaded tubes and traditional atomization devices for inhalation, while the control group received only traditional atomization devices. In the control group, a traditional mask-type atomiser with liquid medicine was employed to align with the end of the endotracheal intubation tube for atomisation inhalation. The experimental group used a threaded tube combined with a traditional atomisation device. The atomizing fluids used included levosalbutamol hydrochloride nebulization solution 0.63g TID, N-acetylcysteine solution for inhalation 0.3g BID, and budesonide suspension for inhalation 2mg BID, with BID administration at 9:00 and 16:00, and TID at 9:00, 17:00, and 1:00. All tubes used had the same inner diameter of 7.5mm. To use the device, the cap at the suction port of the threaded tube was removed, followed by the mask removal. The liquid medicine was then placed into the mask-type atomisation inhalation device, which was connected to the rear end of the threaded tube, while the front end of the threaded tube was connected to the inlet end of the endotracheal intubation tube. Placement was assessed using end-tidal CO₂ monitoring. There was no difference in the time, frequency, and humidifying fluid used for atomisation between the two groups of patients. Both groups received routine nursing care for endotracheal intubation, and the same suctioning method was used for aspiration of sputum. The nebulizer used in both groups was produced by Ningbo Shengrui Medical Appliance Co., Ltd. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Threaded Tube |
| Primary outcome measure(s) |
The following primary outcome measures were assessed at time points on days 1-5 after humidification: |
| Key secondary outcome measure(s) |
The following secondary outcome measures were assessed at time points on days 1-5 after humidification: |
| Completion date | 30/09/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 88 Years |
| Sex | All |
| Target sample size at registration | 105 |
| Total final enrolment | 105 |
| Key inclusion criteria | 1. Aged 18-88 years old 2. Comatose patients undergoing non-mechanical ventilation with endotracheal intubation 3. Patients whose condition could tolerate atomisation inhalation before an operation 4. Patients whose guardians agreed to participate in this trial and provided written informed consent |
| Key exclusion criteria | 1. Patients with an endotracheal intubation retention time of <5 days 2. Patients who underwent endotracheal intubation and switched to mechanical ventilation on days 1 to 5 3. Patients who underwent mechanical ventilation before switching to non-mechanical ventilation after endotracheal intubation 4. Patients who were intubated and then changed to tracheotomy within 5 days 5. Patients with respiratory failure, heart failure and/or severe liver and kidney diseases 6. Patients with acute respiratory failure or acute renal injury |
| Date of first enrolment | 03/03/2020 |
| Date of final enrolment | 01/06/2021 |
Locations
Countries of recruitment
- China
Study participating centre
050000
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets used and analyzed during the current study are available from the corresponding author, Dr Liqiao Zhang, liqiao_zhang@126.com, on reasonable request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
08/10/2024: Study's existence confirmed by the Research Ethics Committee of the Second Hospital of Hebei Medical University.
