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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
Study design Clinical trial: Prospective randomized controlled trial with equal randomization (1:1), double-blinded (Participant and Primary outcome assessor), parallel design
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | conventional nasotracheal intubation procedure | |
| Guided group | Experimental | use suction catheter guided endotracheal tube through the nasal passage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| suction catheter | Device | 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 After the tube tip reach to the pharynx, the suction catheter is withdrawn and tracheal intubation will be completed. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 from video recorded at insert to withdraw videolaryngoscope |
| Incidence of Bleeding | rate of incidence of bleeding
| measured immediately after successful intubation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 immediately after successful intubation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Attempts | The outcome will be recorded as "1,2,3,...." Number of insertion attempt to pass the nasal passage in each participants. | measured immediately after successful intubation |
| Nasal Passage Time |
Inclusion Criteria:
Exclusion Criteria:
Drop-out criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Duangdee Rummasak, M.D. | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry | Ratchathewi | Bangkok | 10400 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 26224998 | Background | 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. | |
| Background | Jongcharoenkamon I, Juajarn T, Pisilp N. Does suction tube guiding reduce epistaxis from nasotracheal intubation? Mahasarakham Hospital Journal. 2020;17(3):210-7. | ||
| 10960403 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | conventional nasotracheal intubation procedure |
| FG001 | Guided Group | use suction catheter guided endotracheal tube through the nasal passage suction catheter: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | conventional nasotracheal intubation procedure |
| BG001 | Guided Group | use suction catheter guided endotracheal tube through the nasal passage suction catheter: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | measured from video recorded at insert to withdraw videolaryngoscope |
|
1 hr after extubation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | conventional nasotracheal intubation procedure | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pattamon Leelachaikul | Mahidol university | +66863019830 | pattamonl@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 11, 2024 | Aug 12, 2024 | Prot_SAP_000.pdf |
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The outcome will be recorded in "unit of seconds"
| measured immediately after successful intubation |
| Background |
| 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. |
| 15833776 | Background | Piepho 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. |
| 40414248 | Derived | Leelachaikul 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Height | Mean | Standard Deviation | centimetres |
|
| ASA physical status | ASA I; normal healthy ASA II; mild systemic disease controllable | Count of Participants | Participants |
|
| Type of Diagnosis | Count of Participants | Participants |
|
| Type of operation | Count of Participants | Participants |
|
| History of smoking | Count of Participants | Participants |
|
| History of alcohol consumption | Count of Participants | Participants |
|
| Hemoglobin | Mean | Standard Deviation | g/dL |
|
| Platelet count | *1000/microliter | Mean | Standard Deviation | platelets/microlitre |
|
| Mean arterial pressure (MAP) | Mean | Standard Deviation | mmHg |
|
| Nostril selected by patient | Count of Participants | Participants |
|
conventional nasotracheal intubation procedure
| OG001 | Guided Group | use suction catheter guided endotracheal tube through the nasal passage suction catheter: 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. |
|
|
|
| Primary | Incidence of Bleeding | rate of incidence of bleeding
| Posted | Count of Participants | Participants | measured immediately after successful intubation |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | measured immediately after successful intubation |
|
|
|
| Other Pre-specified | Number of Attempts | The outcome will be recorded as "1,2,3,...." Number of insertion attempt to pass the nasal passage in each participants. | Posted | Count of Participants | Participants | measured immediately after successful intubation |
|
|
|
| Other Pre-specified | Nasal Passage Time |
The outcome will be recorded in "unit of seconds" | Posted | Median | Full Range | seconds | measured immediately after successful intubation |
|
|
|
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Guided Group | use suction catheter guided endotracheal tube through the nasal passage suction catheter: 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. | 0 | 26 | 0 | 26 | 0 | 26 |
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| Impinged |
|
| 3 |
|
| 6 |
|