Intubation Complication
Conditions
Brief 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 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
Interventions
DEVICEsuction 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 After the tube tip reach to the pharynx, the suction catheter is withdrawn and tracheal intubation will be completed.
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extent of Bleeding | 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 | measured immediately after successful intubation | rate of incidence of bleeding * No Bleeding (Grade 0) * Bleeding (Grade 1, 2, 3) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Navigation | measured immediately after successful intubation | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Attempts | measured immediately after successful intubation | The outcome will be recorded as 1,2,3,.... Number of insertion attempt to pass the nasal passage in each participants. |
| Nasal Passage Time | 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 |
Countries
Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group conventional nasotracheal intubation procedure | 26 |
| 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. | 26 |
| Total | 52 |
Baseline characteristics
| Characteristic | Guided Group | Total | Control Group |
|---|---|---|---|
| Age, Continuous | 28.6 years STANDARD_DEVIATION 10 | 29.8 years STANDARD_DEVIATION 10 | 31 years STANDARD_DEVIATION 10 |
| ASA physical status I | 22 Participants | 43 Participants | 21 Participants |
| ASA physical status II | 4 Participants | 9 Participants | 5 Participants |
| Height | 167.3 centimetres STANDARD_DEVIATION 10.1 | 166.3 centimetres STANDARD_DEVIATION 9.4 | 165.3 centimetres STANDARD_DEVIATION 8.7 |
| Hemoglobin | 13.8 g/dL STANDARD_DEVIATION 1.4 | 13.9 g/dL STANDARD_DEVIATION 1.3 | 14 g/dL STANDARD_DEVIATION 1.3 |
| History of alcohol consumption Never | 14 Participants | 32 Participants | 18 Participants |
| History of alcohol consumption Occasional (<1 time/week) | 11 Participants | 18 Participants | 7 Participants |
| History of alcohol consumption Regular (more than 1 time/week) | 1 Participants | 2 Participants | 1 Participants |
| History of smoking Cessation | 2 Participants | 5 Participants | 3 Participants |
| History of smoking Current | 1 Participants | 2 Participants | 1 Participants |
| History of smoking Never | 23 Participants | 45 Participants | 22 Participants |
| Mean arterial pressure (MAP) | 88 mmHg STANDARD_DEVIATION 11 | 88 mmHg STANDARD_DEVIATION 10 | 89 mmHg STANDARD_DEVIATION 9 |
| Nostril selected by patient Left | 8 Participants | 17 Participants | 9 Participants |
| Nostril selected by patient Right | 12 Participants | 24 Participants | 12 Participants |
| Nostril selected by patient Undecided | 6 Participants | 11 Participants | 5 Participants |
| Platelet count | 271200 platelets/microlitre STANDARD_DEVIATION 64500 | 281100 platelets/microlitre STANDARD_DEVIATION 62900 | 291000 platelets/microlitre STANDARD_DEVIATION 60000.9 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 16 Participants | 31 Participants | 15 Participants |
| Sex: Female, Male Male | 10 Participants | 21 Participants | 11 Participants |
| Type of Diagnosis Dentofacial deformities | 21 Participants | 40 Participants | 19 Participants |
| Type of Diagnosis Miscellaneous | 3 Participants | 7 Participants | 4 Participants |
| Type of Diagnosis Pathology | 2 Participants | 5 Participants | 3 Participants |
| Type of operation Excision and/or reconstruction | 2 Participants | 6 Participants | 4 Participants |
| Type of operation Minor dentoalveolar surgery | 3 Participants | 6 Participants | 3 Participants |
| Type of operation Orthognathic and/or adjunctive surgery | 21 Participants | 40 Participants | 19 Participants |
| Weight | 60 kilograms STANDARD_DEVIATION 10.8 | 59.8 kilograms STANDARD_DEVIATION 10.5 | 59.5 kilograms STANDARD_DEVIATION 10.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 |
Outcome results
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
Time frame: measured from video recorded at insert to withdraw videolaryngoscope
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group | Extent of Bleeding | Grade 0 | 12 Participants |
| Control Group | Extent of Bleeding | Grade 1 | 3 Participants |
| Control Group | Extent of Bleeding | Grade 2 | 4 Participants |
| Control Group | Extent of Bleeding | Grade 3 | 7 Participants |
| Guided Group | Extent of Bleeding | Grade 3 | 7 Participants |
| Guided Group | Extent of Bleeding | Grade 0 | 13 Participants |
| Guided Group | Extent of Bleeding | Grade 2 | 3 Participants |
| Guided Group | Extent of Bleeding | Grade 1 | 3 Participants |
p-value: 1Chi-squared
Primary
Incidence of Bleeding
rate of incidence of bleeding * No Bleeding (Grade 0) * Bleeding (Grade 1, 2, 3)
Time frame: measured immediately after successful intubation
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group | Incidence of Bleeding | No bleeding | 12 Participants |
| Control Group | Incidence of Bleeding | Bleeding | 14 Participants |
| Guided Group | Incidence of Bleeding | No bleeding | 13 Participants |
| Guided Group | Incidence of Bleeding | Bleeding | 13 Participants |
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
Time frame: measured immediately after successful intubation
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group | Ease of Navigation | Smooth | 20 Participants |
| Control Group | Ease of Navigation | Slight resistance | 2 Participants |
| Control Group | Ease of Navigation | Impinged | 4 Participants |
| Guided Group | Ease of Navigation | Smooth | 22 Participants |
| Guided Group | Ease of Navigation | Slight resistance | 3 Participants |
| Guided Group | Ease of Navigation | Impinged | 1 Participants |
Other Pre-specified
Nasal Passage Time
* 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
Time frame: measured immediately after successful intubation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Group | Nasal Passage Time | 5.4 seconds |
| Guided Group | Nasal Passage Time | 10.3 seconds |
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.
Time frame: measured immediately after successful intubation
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group | Number of Attempts | 3 | 1 Participants |
| Control Group | Number of Attempts | 1 | 22 Participants |
| Control Group | Number of Attempts | 6 | 1 Participants |
| Control Group | Number of Attempts | 2 | 2 Participants |
| Guided Group | Number of Attempts | 6 | 0 Participants |
| Guided Group | Number of Attempts | 1 | 25 Participants |
| Guided Group | Number of Attempts | 3 | 1 Participants |
| Guided Group | Number of Attempts | 2 | 0 Participants |