Intubation ComplicationNCT05717907
Suction Catheter as a Guide for Nasotracheal Intubation Under General Anesthesia
A study testing suction catheter in people with Intubation Complication, run by Mahidol University at 1 site in Thailand.
Trial summary
The goal of this clinical trial to study the efficacy of suction catheter guided technique and conventional technique during nasotracheal intubation. The main question are How effective of the use of a suction catheter guided ETT in reducing bleeding during nasotracheal intubation? Does the use of a suction catheter… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intubation Complication
- What is being tested?
- suction catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteThailand
- Study dates
- 5 Sep 2023to 10 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing elective oral and maxillofacial surgery in which nasotracheal intubation is preferred over orotracheal intubation to optimize surgical access.
- ASA physical status I-II
- Thai adult, aged 18-65 years old
- Normal Body Mass Index (BMI = 18.5-24.9)
Who cannot join
- Anticipated difficult airway (e.g., Mallampati classification 3-4, interincisal distance < 35 mm., thyromental length < 60 mm., limited neck mobility)
- Nasal infection or systemic infection
- Abnormal coagulation status or having bleeding disorder or taking anticoagulation/antiplatelet medication
- History of recurrent epistaxis since adulthood
- Allergic rhinitis that necessitates the use of glucocorticoids, antihistamine, antileukotriene or decongestant in the past 4 weeks
- History of nasal trauma or abnormality (e.g., trauma in mid-face region, nasal surgery, nasal polyps, chronic sinusitis, abnormal nasal vasculature, tumor in nasal region, radiotherapy in nasal region)
Show all 15Show fewer
- Craniofacial deformity syndrome
- Using nasal oxygen or Continuous Positive Airway Pressure (CPAP)
- Previous nasotracheal intubation or nasogastric tube placement within 3 months
- Diagnosed as having a mental disorder
- Drop-out criteria:
- Unable to complete intubation procedure
- Intubation failed on both nostrils
- When intubation was only possible with a tube smaller than 6.5 internal diameter (ID) in male and 6.0 ID in female
- Inadequate data collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Suction Catheter as a Guide for Nasotracheal Intubation Under General Anesthesia: Randomized Clinical Trial of Efficacy
The goal of this clinical trial to study the efficacy of suction catheter guided technique and conventional technique during nasotracheal intubation.
The main question are
- How effective of the use of a suction catheter guided ETT in reducing bleeding during nasotracheal intubation?
- Does the use of a suction catheter guided ETT can improve its navigability through the nasal passage and reduce nasal passage time?
Read the detailed description
Study design Clinical trial: Prospective randomized controlled trial with equal randomization (1:1), double-blinded (Participant and Primary outcome assessor), parallel design
- Conditions
- Intubation Complication
- Being tested
- suction catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suction catheterDevice
a suction catheter will be first inserted through the ETT so that about 10 cm of the catheter was protruding from the distal end of the tube. The tip of the catheter is then inserted through the selected nostril until it passes to the pharynx. If resistance is felt to the passage of catheter, the other nostril will be tried. The nostril with less resistance to the catheter passage will be chosen for the completion of the procedure. The Endotracheal tube is then advance over the catheter through the nasal passage while holding the catheter proximal to the tube to prevent its advancement with the tube. After the tube tip reach to the pharynx, the suction catheter is withdrawn and tracheal intubation will be completed.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | conventional nasotracheal intubation procedure |
| Guided group | Experimental | use suction catheter guided endotracheal tube through the nasal passage Receives: Device: suction catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of Bleeding
The video from video laryngoscope will be recorded at the moment during and immediately after successful intubation, which will be later reviewed by primary outcome assessor that not involved in the procedure. Accounting for only bleeding observed at posterior pharyngeal area, which originate from trauma from attempt to pass ETT through the nasal passage into the pharynx. Assessment of bleeding will be scored at the most severe bleeding state observed from inserting to the removal of video laryngoscope after successful intubation. The extent of bleeding will be graded as:
"Grade 0" = no bleeding "Grade 1" = blood-stained tube and/or cuff "Grade 2" = blood-stained posterior pharyngeal wall (traces or streak of blood) "Grade 3" = blood pooling at posterior pharyngeal wall
Measured: measured from video recorded at insert to withdraw videolaryngoscope
Incidence of Bleeding
rate of incidence of bleeding
- No Bleeding (Grade 0)
- Bleeding (Grade 1, 2, 3)
Measured: measured immediately after successful intubation
Secondary outcomes (1)
Ease of Navigation
Ease of navigation during advancement of tube though the nasal passage, will be recorded as "Smooth" = ETT meet no resistance, no need to adjust the tube "Slight resistance" = ETT meet the resistance and has to be manipulated more than once "Impinged" = ETT cannot pass through and need to move to another nostril
Measured: measured immediately after successful intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start5 Sep 2023
- Primary completion9 Jun 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Intubation ComplicationStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duangdee Rummasak, Mahidol University
- Investigators
- Duangdee Rummasak, M.D., Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717907
- Sponsor's protocol ID
- 2023/DT039
- Status last verified
- Nov 2024
- First submitted
- 16 Jan 2023
- Last updated
- 20 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anwer HM.F., Ibrahim AA. Suction catheter guidance of the endotracheal tube to facilitate nasal intubation: a double blind, randomized clinical trial. MEJA.2018;25 (2):155-63.
Prasanna D, Bhat S. Nasotracheal Intubation: An Overview. J Maxillofac Oral Surg. 2014 Dec;13(4):366-72. doi: 10.1007/s12663-013-0516-5. Epub 2013 May 1.
PubMed 26224998Jongcharoenkamon I, Juajarn T, Pisilp N. Does suction tube guiding reduce epistaxis from nasotracheal intubation? Mahasarakham Hospital Journal. 2020;17(3):210-7.
Kim YC, Lee SH, Noh GJ, Cho SY, Yeom JH, Shin WJ, Lee DH, Ryu JS, Park YS, Cha KJ, Lee SC. Thermosoftening treatment of the nasotracheal tube before intubation can reduce epistaxis and nasal damage. Anesth Analg. 2000 Sep;91(3):698-701. doi: 10.1097/00000539-200009000-00038.
PubMed 10960403Piepho T, Thierbach A, Werner C. Nasotracheal intubation: look before you leap. Br J Anaesth. 2005 Jun;94(6):859-60. doi: 10.1093/bja/aei146. Epub 2005 Apr 15.
PubMed 15833776Leelachaikul P, Rummasak D, Lertwisettheerakun T, Akaraprasertkul J. Does Suction Catheter-Guided Nasotracheal Intubation Reduce Nasal Bleeding? J Oral Maxillofac Surg. 2025 Aug;83(8):928-936. doi: 10.1016/j.joms.2025.05.001. Epub 2025 May 8.
PubMed 40414248
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suction Catheter as a Guide for Nasotracheal Intubation Under General Anesthesia: Randomized Clinical Trial of Efficacy
- ClinicalTrials.gov ID
- NCT05717907
- Acronym / sponsor ID
- 2023/DT039
- Conditions
- Intubation Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 9 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Posted 20 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial to study the efficacy of suction catheter guided technique and conventional technique during nasotracheal intubation.
The main question are
- How effective of the use of a suction catheter guided ETT in reducing bleeding during nasotracheal intubation?
- Does the use of a suction catheter guided ETT can improve its navigability through the nasal passage and reduce nasal passage time?
Detailed description
Study design Clinical trial: Prospective randomized controlled trial with equal randomization (1:1), double-blinded (Participant and Primary outcome assessor), parallel design
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –conventional nasotracheal intubation procedure |
| Guided group | Experimental | Device: suction catheteruse suction catheter guided endotracheal tube through the nasal passage |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient undergoing elective oral and maxillofacial surgery in which nasotracheal intubation is preferred over orotracheal intubation to optimize surgical access.
- ASA physical status I-II
- Thai adult, aged 18-65 years old
- Normal Body Mass Index (BMI = 18.5-24.9)
Key exclusion criteria (15 listed)
- Anticipated difficult airway (e.g., Mallampati classification 3-4, interincisal distance < 35 mm., thyromental length < 60 mm., limited neck mobility)
- Nasal infection or systemic infection
- Abnormal coagulation status or having bleeding disorder or taking anticoagulation/antiplatelet medication
- History of recurrent epistaxis since adulthood
- Allergic rhinitis that necessitates the use of glucocorticoids, antihistamine, antileukotriene or decongestant in the past 4 weeks
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 |
|---|---|---|
| suction cathetera suction catheter will be first inserted through the ETT so that about 10 cm of the catheter was protruding from the distal end of the tube. The tip of the catheter is then inserted through the selected nostril until it passes to the pharynx. If resistance is felt to the passage of catheter, the other nostril will be tried. The nostril with less resistance to the catheter passage will be chosen for the completion of the procedure. The Endotracheal tube is then advance over the catheter through the nasal passage while holding the catheter proximal to the tube to prevent its advancement with the tube. After the tube tip reach to the pharynx, the suction catheter is withdrawn and tracheal intubation will be completed. | Device | Guided group |
Primary outcome
Extent of Bleeding
Time frame: measured from video recorded at insert to withdraw videolaryngoscope
The video from video laryngoscope will be recorded at the moment during and immediately after successful intubation, which will be later reviewed by primary outcome assessor that not involved in the procedure. Accounting for only bleeding observed at posterior pharyngeal area, which originate from trauma from attempt to pass ETT through the nasal passage into the pharynx. Assessment of bleeding will be scored at the most severe bleeding state observed from inserting to the removal of video laryngoscope after successful intubation. The extent of bleeding will be graded as: "Grade 0" = no bleeding "Grade 1" = blood-stained tube and/or cuff "Grade 2" = blood-stained posterior pharyngeal wall (traces or streak of blood) "Grade 3" = blood pooling at posterior pharyngeal wall
Incidence of Bleeding
Time frame: measured immediately after successful intubation
rate of incidence of bleeding * No Bleeding (Grade 0) * Bleeding (Grade 1, 2, 3)
1 secondary outcome
Ease of Navigation
Time frame: measured immediately after successful intubation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundAnwer HM.F., Ibrahim AA. Suction catheter guidance of the endotracheal tube to facilitate nasal intubation: a double blind, randomized clinical trial. MEJA.2018;25 (2):155-63.
- Background: PubMed 26224998Prasanna D, Bhat S. Nasotracheal Intubation: An Overview. J Maxillofac Oral Surg. 2014 Dec;13(4):366-72. doi: 10.1007/s12663-013-0516-5. Epub 2013 May 1.
- BackgroundJongcharoenkamon I, Juajarn T, Pisilp N. Does suction tube guiding reduce epistaxis from nasotracheal intubation? Mahasarakham Hospital Journal. 2020;17(3):210-7.
- Background: PubMed 10960403Kim YC, Lee SH, Noh GJ, Cho SY, Yeom JH, Shin WJ, Lee DH, Ryu JS, Park YS, Cha KJ, Lee SC. Thermosoftening treatment of the nasotracheal tube before intubation can reduce epistaxis and nasal damage. Anesth Analg. 2000 Sep;91(3):698-701. doi: 10.1097/00000539-200009000-00038.
- Background: PubMed 15833776Piepho T, Thierbach A, Werner C. Nasotracheal intubation: look before you leap. Br J Anaesth. 2005 Jun;94(6):859-60. doi: 10.1093/bja/aei146. Epub 2005 Apr 15.
- Derived from this study: PubMed 40414248Leelachaikul P, Rummasak D, Lertwisettheerakun T, Akaraprasertkul J. Does Suction Catheter-Guided Nasotracheal Intubation Reduce Nasal Bleeding? J Oral Maxillofac Surg. 2025 Aug;83(8):928-936. doi: 10.1016/j.joms.2025.05.001. Epub 2025 May 8.
- 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.
Duangdee Rummasak, M.D. principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing suction catheter in people with Intubation Complication, run by Mahidol University at 1 site in Thailand.
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 4 inclusion and 15 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 20 Dec 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 Thailand. 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?
Yes. Results are posted in the registry (first posted 20 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Extent of Bleeding (time frame: measured from video recorded at insert to withdraw videolaryngoscope). The study lists 2 primary outcomes in all. 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 NCT05717907, which also lists 6 linked publications.
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 20 Dec 2024.