Fixation Device; ComplicationsNCT05643053
Comparison of Endotracheal Tube Fixation Methods in Prone Position
A study testing thomas fixation, elastic band and normal fixation adhesive tape in people with Fixation Device; Complications, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In particular, prone position surgeries risk potentially life-threatening ET tube dislocation. Failure to place the plaster used for ET tube fixation correctly and adequately in this position may contaminate the patch with body fluids and loosen the weight of the breathing circuit, causing the ET tube to slip and… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Fixation Device; Complications
- What is being tested?
- thomas fixation, elastic band and normal fixation adhesive tape
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 10 Jun 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA Physical Status I-II
- Mallampati score I-II
Who cannot join
- Patients who did not want to participate in the study
- Restricted mouth opening
- BMI ≥ 35 kg/m2
- Risk of airway malformation and aspiration (gastroesophageal reflux, hiatal -hernia, history of previous gastric surgery, GIS motility disorder)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Medical Science, Yıldırım Beyazıt Training and Research Hospital
Ankara
About this study
Official title: Impact of Endotracheal Tube Fixation Methods on Tube Displacement During Pron Position
In particular, prone position surgeries risk potentially life-threatening ET tube dislocation. Failure to place the plaster used for ET tube fixation correctly and adequately in this position may contaminate the patch with body fluids and loosen the weight of the breathing circuit, causing the ET tube to slip and dislodge. Adhesive tape (plaster), bandage (non-adhesive), suturing, or a commercially available tube holding device are recommended for ET tube fixation in patients operated in the prone position. In addition, the adhesive plasters used can be taped on the patient's face to the maxilla, mandible, or both. Because of the urgent and critical settings, a fast, reliable, and easy-to-use method of ET tube fixation is invaluable as it will provide clinicians with greater confidence in the stability of alternative airways and reduce complications from airway maintenance. In our clinic, different fixation methods are used according to the experience and preference of the anesthesiologist. Our study aims to compare other fixation methods using FOB to fix the position of the ET tube with an appropriate method in prone position procedures and ensure that patients have safe airway management throughout the surgery.
- Conditions
- Fixation Device; Complications
- Being tested
- thomas fixation, elastic band, normal fixation adhesive tape, reinforced adhesive tape fixation
- Keywords
- endotracheal tube fixation, fiberoptic bronchoscopy, prone position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thomas fixationOther
Use of the thomas tube holder for endotracheal tube fixation in patients operated in the prone position
elastic bandOther
Use of the elastic band for endotracheal tube fixation in patients operated in the prone position
normal fixation adhesive tapeOther
Use of the adhesive tape for endotracheal tube fixation in patients operated in the prone position
reinforced adhesive tape fixationOther
Use of the reinforced adhesive tape fixation for endotracheal tube fixation in patients operated in the prone position
| Study group | Role | What they receive |
|---|---|---|
| thomas fixation | Experimental | Not described Receives: Other: thomas fixation |
| elastic band | Experimental | Not described Receives: Other: elastic band |
| normal fixation adhesive tape | Experimental | Not described Receives: Other: normal fixation adhesive tape |
| reinforced adhesive tape fixation | Experimental | Not described Receives: Other: reinforced adhesive tape fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct placement and subsequent fixation of the endotracheal tube in the prone patient
Measured: periopeative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Sep 2022
- Primary completion9 Sep 2023
- Study completion10 Jun 2024
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 Fixation Device; ComplicationsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Funda Atar, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643053
- Sponsor's protocol ID
- 18/07/2022 142/05
- Status last verified
- Jun 2024
- First submitted
- 23 Nov 2022
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Singh G, Manikandan S, Neema PK. Endotracheal tube fixation in neurosurgical procedures operated in prone position. J Anaesthesiol Clin Pharmacol. 2011 Oct;27(4):574-5. doi: 10.4103/0970-9185.86621. No abstract available.
PubMed 22096310
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Endotracheal Tube Fixation Methods on Tube Displacement During Pron Position
- ClinicalTrials.gov ID
- NCT05643053
- Acronym / sponsor ID
- 18/07/2022 142/05
- Conditions
- Fixation Device; Complications
- Keywords
- endotracheal tube fixation, fiberoptic bronchoscopy, prone position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 9 Sep 2023 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 8 Dec 2022 (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 particular, prone position surgeries risk potentially life-threatening ET tube dislocation. Failure to place the plaster used for ET tube fixation correctly and adequately in this position may contaminate the patch with body fluids and loosen the weight of the breathing circuit, causing the ET tube to slip and dislodge. Adhesive tape (plaster), bandage (non-adhesive), suturing, or a commercially available tube holding device are recommended for ET tube fixation in patients operated in the prone position. In addition, the adhesive plasters used can be taped on the patient's face to the maxilla, mandible, or both. Because of the urgent and critical settings, a fast, reliable, and easy-to-use method of ET tube fixation is invaluable as it will provide clinicians with greater confidence in the stability of alternative airways and reduce complications from airway maintenance. In our clinic, different fixation methods are used according to the experience and preference of the anesthesiologist. Our study aims to compare other fixation methods using FOB to fix the position of the ET tube with an appropriate method in prone position procedures and ensure that patients have safe airway management throughout the surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| thomas fixation | Experimental | Other: thomas fixation |
| elastic band | Experimental | Other: elastic band |
| normal fixation adhesive tape | Experimental | Other: normal fixation adhesive tape |
| reinforced adhesive tape fixation | Experimental | Other: reinforced adhesive tape fixation |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA Physical Status I-II
- Mallampati score I-II
Key exclusion criteria (4 listed)
- Patients who did not want to participate in the study
- Restricted mouth opening
- BMI ≥ 35 kg/m2
- Risk of airway malformation and aspiration (gastroesophageal reflux, hiatal -hernia, history of previous gastric surgery, GIS motility disorder)
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 |
|---|---|---|
| thomas fixationUse of the thomas tube holder for endotracheal tube fixation in patients operated in the prone position | Other | thomas fixation |
| elastic bandUse of the elastic band for endotracheal tube fixation in patients operated in the prone position | Other | elastic band |
| normal fixation adhesive tapeUse of the adhesive tape for endotracheal tube fixation in patients operated in the prone position | Other | normal fixation adhesive tape |
| reinforced adhesive tape fixationUse of the reinforced adhesive tape fixation for endotracheal tube fixation in patients operated in the prone position | Other | reinforced adhesive tape fixation |
Primary outcome
Correct placement and subsequent fixation of the endotracheal tube in the prone patient
Time frame: periopeative
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 11 Jun 2024.
- Background: PubMed 22096310Singh G, Manikandan S, Neema PK. Endotracheal tube fixation in neurosurgical procedures operated in prone position. J Anaesthesiol Clin Pharmacol. 2011 Oct;27(4):574-5. doi: 10.4103/0970-9185.86621. No abstract available.
- Individual participant dataSharing planned: No
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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 thomas fixation, elastic band and normal fixation adhesive tape in people with Fixation Device; Complications, run by Diskapi Yildirim Beyazit Education and Research Hospital 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 4 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 11 Jun 2024. 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?
Correct placement and subsequent fixation of the endotracheal tube in the prone patient (time frame: periopeative). 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 NCT05643053, 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 11 Jun 2024.