Trial Outcomes & Findings for Suction Catheter as a Guide for Nasotracheal Intubation Under General Anesthesia (NCT NCT05717907)
NCT ID: NCT05717907
Last Updated: 2024-12-20
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
measured from video recorded at insert to withdraw videolaryngoscope
Results posted on
2024-12-20
Participant Flow
Participant milestones
| Measure |
Control Group
conventional nasotracheal intubation procedure
|
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 After the tube tip reach to the pharynx, the suction catheter is withdrawn and tracheal intubation will be completed.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
|
Overall Study
COMPLETED
|
26
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control Group
n=26 Participants
conventional nasotracheal intubation procedure
|
Guided Group
n=26 Participants
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.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31 years
STANDARD_DEVIATION 10 • n=26 Participants
|
28.6 years
STANDARD_DEVIATION 10 • n=26 Participants
|
29.8 years
STANDARD_DEVIATION 10 • n=52 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=26 Participants
|
16 Participants
n=26 Participants
|
31 Participants
n=52 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=26 Participants
|
10 Participants
n=26 Participants
|
21 Participants
n=52 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Weight
|
59.5 kilograms
STANDARD_DEVIATION 10.3 • n=26 Participants
|
60 kilograms
STANDARD_DEVIATION 10.8 • n=26 Participants
|
59.8 kilograms
STANDARD_DEVIATION 10.5 • n=52 Participants
|
|
Height
|
165.3 centimetres
STANDARD_DEVIATION 8.7 • n=26 Participants
|
167.3 centimetres
STANDARD_DEVIATION 10.1 • n=26 Participants
|
166.3 centimetres
STANDARD_DEVIATION 9.4 • n=52 Participants
|
|
ASA physical status
I
|
21 Participants
n=26 Participants
|
22 Participants
n=26 Participants
|
43 Participants
n=52 Participants
|
|
ASA physical status
II
|
5 Participants
n=26 Participants
|
4 Participants
n=26 Participants
|
9 Participants
n=52 Participants
|
|
Type of Diagnosis
Dentofacial deformities
|
19 Participants
n=26 Participants
|
21 Participants
n=26 Participants
|
40 Participants
n=52 Participants
|
|
Type of Diagnosis
Pathology
|
3 Participants
n=26 Participants
|
2 Participants
n=26 Participants
|
5 Participants
n=52 Participants
|
|
Type of Diagnosis
Miscellaneous
|
4 Participants
n=26 Participants
|
3 Participants
n=26 Participants
|
7 Participants
n=52 Participants
|
|
Type of operation
Orthognathic and/or adjunctive surgery
|
19 Participants
n=26 Participants
|
21 Participants
n=26 Participants
|
40 Participants
n=52 Participants
|
|
Type of operation
Excision and/or reconstruction
|
4 Participants
n=26 Participants
|
2 Participants
n=26 Participants
|
6 Participants
n=52 Participants
|
|
Type of operation
Minor dentoalveolar surgery
|
3 Participants
n=26 Participants
|
3 Participants
n=26 Participants
|
6 Participants
n=52 Participants
|
|
History of smoking
Never
|
22 Participants
n=26 Participants
|
23 Participants
n=26 Participants
|
45 Participants
n=52 Participants
|
|
History of smoking
Cessation
|
3 Participants
n=26 Participants
|
2 Participants
n=26 Participants
|
5 Participants
n=52 Participants
|
|
History of smoking
Current
|
1 Participants
n=26 Participants
|
1 Participants
n=26 Participants
|
2 Participants
n=52 Participants
|
|
History of alcohol consumption
Never
|
18 Participants
n=26 Participants
|
14 Participants
n=26 Participants
|
32 Participants
n=52 Participants
|
|
History of alcohol consumption
Occasional (<1 time/week)
|
7 Participants
n=26 Participants
|
11 Participants
n=26 Participants
|
18 Participants
n=52 Participants
|
|
History of alcohol consumption
Regular (more than 1 time/week)
|
1 Participants
n=26 Participants
|
1 Participants
n=26 Participants
|
2 Participants
n=52 Participants
|
|
Hemoglobin
|
14 g/dL
STANDARD_DEVIATION 1.3 • n=26 Participants
|
13.8 g/dL
STANDARD_DEVIATION 1.4 • n=26 Participants
|
13.9 g/dL
STANDARD_DEVIATION 1.3 • n=52 Participants
|
|
Platelet count
|
291000 platelets/microlitre
STANDARD_DEVIATION 60000.9 • n=26 Participants
|
271200 platelets/microlitre
STANDARD_DEVIATION 64500 • n=26 Participants
|
281100 platelets/microlitre
STANDARD_DEVIATION 62900 • n=52 Participants
|
|
Mean arterial pressure (MAP)
|
89 mmHg
STANDARD_DEVIATION 9 • n=26 Participants
|
88 mmHg
STANDARD_DEVIATION 11 • n=26 Participants
|
88 mmHg
STANDARD_DEVIATION 10 • n=52 Participants
|
|
Nostril selected by patient
Right
|
12 Participants
n=26 Participants
|
12 Participants
n=26 Participants
|
24 Participants
n=52 Participants
|
|
Nostril selected by patient
Left
|
9 Participants
n=26 Participants
|
8 Participants
n=26 Participants
|
17 Participants
n=52 Participants
|
|
Nostril selected by patient
Undecided
|
5 Participants
n=26 Participants
|
6 Participants
n=26 Participants
|
11 Participants
n=52 Participants
|
PRIMARY outcome
Timeframe: measured from video recorded at insert to withdraw videolaryngoscopeThe 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
Outcome measures
| Measure |
Control Group
n=26 Participants
conventional nasotracheal intubation procedure
|
Guided Group
n=26 Participants
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.
|
|---|---|---|
|
Extent of Bleeding
Grade 0
|
12 Participants
|
13 Participants
|
|
Extent of Bleeding
Grade 1
|
3 Participants
|
3 Participants
|
|
Extent of Bleeding
Grade 2
|
4 Participants
|
3 Participants
|
|
Extent of Bleeding
Grade 3
|
7 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: measured immediately after successful intubationrate of incidence of bleeding * No Bleeding (Grade 0) * Bleeding (Grade 1, 2, 3)
Outcome measures
| Measure |
Control Group
n=26 Participants
conventional nasotracheal intubation procedure
|
Guided Group
n=26 Participants
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.
|
|---|---|---|
|
Incidence of Bleeding
Bleeding
|
14 Participants
|
13 Participants
|
|
Incidence of Bleeding
No bleeding
|
12 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: measured immediately after successful intubationEase 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
Outcome measures
| Measure |
Control Group
n=26 Participants
conventional nasotracheal intubation procedure
|
Guided Group
n=26 Participants
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.
|
|---|---|---|
|
Ease of Navigation
Smooth
|
20 Participants
|
22 Participants
|
|
Ease of Navigation
Slight resistance
|
2 Participants
|
3 Participants
|
|
Ease of Navigation
Impinged
|
4 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: measured immediately after successful intubationThe outcome will be recorded as "1,2,3,...." Number of insertion attempt to pass the nasal passage in each participants.
Outcome measures
| Measure |
Control Group
n=26 Participants
conventional nasotracheal intubation procedure
|
Guided Group
n=26 Participants
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.
|
|---|---|---|
|
Number of Attempts
1
|
22 Participants
|
25 Participants
|
|
Number of Attempts
2
|
2 Participants
|
0 Participants
|
|
Number of Attempts
3
|
1 Participants
|
1 Participants
|
|
Number of Attempts
6
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: measured immediately after successful intubation* Control group: starting when the tip of the ETT just enter the anterior nares until the tip of the ETT just pass the posterior nares and entered the pharynx * Guided group: starting when the tip of the guiding suction catheter just entered the anterior nares until the tip of the ETT passed the posterior nares, then entered the pharynx and the guiding catheter was completely removed from the ETT. The outcome will be recorded in "unit of seconds"
Outcome measures
| Measure |
Control Group
n=26 Participants
conventional nasotracheal intubation procedure
|
Guided Group
n=26 Participants
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.
|
|---|---|---|
|
Nasal Passage Time
|
5.4 seconds
Interval 3.1 to 67.5
|
10.3 seconds
Interval 6.0 to 42.2
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Guided Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place