The Fixation Mainly Plays a Firm Role in the Tracheal Intubation and Reduces the Occurrence of ComplicationsNCT04707521
Application of Ship - Shaped Adhesive Tape Fixing in Patients Undergoing Tracheal Intubation
A study testing 3M tape ship-shaped combined with strap fixing method in people with The Fixation Mainly Plays a Firm Role in the Tracheal Intubation and Reduces the Occurrence of Complications, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
In order to evaluate the safety and value of the improved ship-shaped fixing on tracheal intubation patients and provide theoretical basis for clinical therapy, we conducted this research to compare the fixed effectiveness, complications, nursing workload and medical expenses about application of ship-shaped adhesive… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- The Fixation Mainly Plays a Firm Role in the Tracheal Intubation and Reduces the Occurrence of Complications
- What is being tested?
- 3M tape ship-shaped combined with strap fixing method
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to 31 Dec 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with SICU intubation had been intubated for <8h at the time of entry (the interval of oral care was 8h);
- Patients with brain diseases or septic shock caused by abdominal infection;
- There was no pulmonary infection before endotracheal intubation.
- Facial skin integrity;
- Good oral cavity: no odor, no residue, no oral diseases, oral mucosa integrity;
- Informed consent is given by the family members and the informed consent is signed;
- No adhesive tape allergy.
Who cannot join
- Oral injury caused by suction;
- Endotracheal intubation time < 48 h;
- In the experiment is not willing to carry on the experiment, quit voluntarily.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Official title: Application of Ship - Shaped Adhesive Tape Fixing in Patients Undergoing Tracheal
In order to evaluate the safety and value of the improved ship-shaped fixing on tracheal intubation patients and provide theoretical basis for clinical therapy, we conducted this research to compare the fixed effectiveness, complications, nursing workload and medical expenses about application of ship-shaped adhesive tape fixation on patient undergoing tracheal intubation.
Read the detailed description
the fixed effectiveness：Incidence of catheter displacement，Incidence of unplanned extubation.
complications：Incidence f skin damage，Oral care effect，Incidence of ventilator-associated pneumonia.
nursing workload:Oral care is time-consuming medical expenses :Material economic cost
- Being tested
- 3M tape ship-shaped combined with strap fixing method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3M tape ship-shaped combined with strap fixing methodBehavioural
During fixation, the endotracheal intubation and dental pad were located in the center of the mouth, and one end of one piece of medical cloth adhesive was pasted on the patient's cheek near the side. When it reached one side of the mouth, the endotracheal intubation and dental pad were wound around twice, and then the other side of the adhesive tape was pasted on the cheek opposite the side from the other side of the mouth,The other is fixed in reverse with the same sticking method, and the two pieces of adhesive tape are finally crossed and fixed at the corners of the mouth.Finally, fasten it with a lacing
| Study group | Role | What they receive |
|---|---|---|
| 3M tape ship-shaped combined with strap fixing method | Experimental | 1. Cutting method of 3M adhesive tape of ship shape: cut a piece of 20cm×3cm elastic adhesive tape, fold it in half to form a rectangle of 10cm×3cm, cut 5cm straight line from the middle point of the crease, cut it at an Angle of 45°, fold and open the 3M elastic adhesive tape in half, which is the adhesive tape required for fixing. The final shape is similar to that of a ship, and it is named as 3M adhesive tape of ship shape.
2. Fixation method: The ship shape with 3M adhesive tape was pasted upward on the opposite cheek (near zygomatic), and the endotracheal intubation was wound around for two rounds and then glued to the near cheek (near zygomatic).Put the tooth pad next to the endotracheal intubation and wrap the tooth pad and catheter together for two turns with a short 3M adhesive tape of 12cm×1.5cm.Finally, fasten it with a lacing. Receives: Behavioral: 3M tape ship-shaped combined with strap fixing method |
| traditional X-shaped tape and string fixing | No intervention | traditional X-shaped tape and string fixing |
What is being measured
The primary outcome is the main question the study is designed to answer.
the fixed effectiveness of endotracheal intubation
The tube displacement rate,
Measured: 34 weeks
Secondary outcomes (1)
Complications associated with endotracheal intubation fixation
Unplanned extubation,the occurrence of facial adhesive related skin injury,Effect of oral care
Measured: 34 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start1 Apr 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Fixation Mainly Plays a Firm Role in the Tracheal Intubation and Reduces the Occurrence of ComplicationsStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3M tape ship-shaped combined with strap fixing method
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707521
- Sponsor's protocol ID
- 2018-144
- Status last verified
- Jan 2021
- First submitted
- 17 Jun 2020
- Last updated
- 13 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Ship - Shaped Adhesive Tape Fixing in Patients Undergoing Tracheal
- ClinicalTrials.gov ID
- NCT04707521
- Acronym / sponsor ID
- 2018-144
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 13 Jan 2021 (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 order to evaluate the safety and value of the improved ship-shaped fixing on tracheal intubation patients and provide theoretical basis for clinical therapy, we conducted this research to compare the fixed effectiveness, complications, nursing workload and medical expenses about application of ship-shaped adhesive tape fixation on patient undergoing tracheal intubation.
Detailed description
the fixed effectiveness：Incidence of catheter displacement，Incidence of unplanned extubation.
complications：Incidence f skin damage，Oral care effect，Incidence of ventilator-associated pneumonia.
nursing workload:Oral care is time-consuming medical expenses :Material economic cost
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 3M tape ship-shaped combined with strap fixing method
| Arm | Type | Receives |
|---|---|---|
| 3M tape ship-shaped combined with strap fixing method | Experimental | Behavioral: 3M tape ship-shaped combined with strap fixing method1. Cutting method of 3M adhesive tape of ship shape: cut a piece of 20cm×3cm elastic adhesive tape, fold it in half to form a rectangle of 10cm×3cm, cut 5cm straight line from the middle point of the crease, cut it at an Angle of 45°, fold and open the 3M elastic adhesive tape in half, which is the adhesive tape required for fixing. The final shape is similar to that of a ship, and it is named as 3M adhesive tape of ship shape. 2. Fixation method: The ship shape with 3M adhesive tape was pasted upward on the opposite cheek (near zygomatic), and the endotracheal intubation was wound around for two rounds and then glued to the near cheek (near zygomatic).Put the tooth pad next to the endotracheal intubation and wrap the tooth pad and catheter together for two turns with a short 3M adhesive tape of 12cm×1.5cm.Finally, fasten it with a lacing. |
| traditional X-shaped tape and string fixing | No intervention | –traditional X-shaped tape and string fixing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with SICU intubation had been intubated for <8h at the time of entry (the interval of oral care was 8h);
- Patients with brain diseases or septic shock caused by abdominal infection;
- There was no pulmonary infection before endotracheal intubation.
- Facial skin integrity;
- Good oral cavity: no odor, no residue, no oral diseases, oral mucosa integrity;
Key exclusion criteria (3 listed)
- Oral injury caused by suction;
- Endotracheal intubation time < 48 h;
- In the experiment is not willing to carry on the experiment, quit voluntarily.
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 |
|---|---|---|
| 3M tape ship-shaped combined with strap fixing methodDuring fixation, the endotracheal intubation and dental pad were located in the center of the mouth, and one end of one piece of medical cloth adhesive was pasted on the patient's cheek near the side. When it reached one side of the mouth, the endotracheal intubation and dental pad were wound around twice, and then the other side of the adhesive tape was pasted on the cheek opposite the side from the other side of the mouth,The other is fixed in reverse with the same sticking method, and the two pieces of adhesive tape are finally crossed and fixed at the corners of the mouth.Finally, fasten it with a lacing | Behavioural | 3M tape ship-shaped combined with strap fixing method |
Primary outcome
the fixed effectiveness of endotracheal intubation
Time frame: 34 weeks
The tube displacement rate,
1 secondary outcome
Complications associated with endotracheal intubation fixation
Time frame: 34 weeks
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 13 Jan 2021.
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 3M tape ship-shaped combined with strap fixing method in people with The Fixation Mainly Plays a Firm Role in the Tracheal Intubation and Reduces the Occurrence of Complications, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 7 inclusion and 3 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 13 Jan 2021. 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 China. 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?
the fixed effectiveness of endotracheal intubation (time frame: 34 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2021.