Intubation; Difficult
Conditions
Keywords
Shikani optical stylet(SOS), difficult airways, intubation
Brief summary
Difficult airways is still a challenging issue for the anesthesiologists in spite of the development of various techniques.Shikani optical stylet(SOS), combining the features of fiberoptic bronchoscope and a lightwand, has been used for orotracheal intubation with difficult airways. As compared with fiberoptic bronchoscope, SOS is less expensive, easy to learn and more durable. However, it remains elusive whether SOS can be used in the nasotracheal intubation in the oral and maxillofacial surgery, which normally requires the nasotracheal intubation. The present study evaluates the safety and efficacy of SOS for nasotracheal intubation in the oral and maxillofacial surgery requiring nasotracheal intubation.
Detailed description
The present study has been approved by the Research Ethics Committee of the Second Xiangya Hospital of Central South University . Informed and written consent will be obtained from patients who are undergoing oral and maxillofacial surgery requiring general anesthesia with nasotracheal intubation. Preoperative clinical assessment of the patients will include routine airway evaluation of dentition, mouth opening, tongue size, Mallampati score, and neck mobility. For the patients without anticipated difficult intubations. Patients will be induced by the routine anesthesia fashion including 0.1mg/kg midazolam, 3-8mcg/kg fentanyl, 0.08-.015mg/kg vecuronium and 0.3mg/kg etomidate with standard preoxygen. The patients will be ventilated with 100% oxygen via bag and mask for 3 minutes. For the patients with anticipated difficult airways. Patients will be inhaled with sevoflurane in 100% oxygen. Some protocols will be performed as the following: 1)If the patient can be ventilated with bag and mask after losing consciousness, 0.3mg/kg etomidate and 1-2mg/kg succinylcholine will be administered for muscle paralysis. If not, sevoflurane will be stopped and the patient will be awakened. Fiberoptic bronchoscope will be performed for the intubation; 2)If two attempts of intubation with SOS are failed, then the direct laryngoscope will be used for the intubation; If the intubation with direct laryngoscope is also failed, the patients will be awakened and intubated in the awake status. After confirmation of the successful intubation, the routine anesthesia fashion will be followed and the surgery will be performed as the usual fashion. Intubation time will be defined as the time from when Shikani stylet passes the nose of the patient until the time the endotracheal tube is positioned in the trachea. If the intubation sequence is longer than 120 seconds, it will be deemed a failure and recorded as such.
Interventions
PROCEDURENasotracheal Intubation through seeing optical stylet (SOS)
Nasotracheal intubation using seeing optical stylet in the patients with the anticipated difficult intubation. Arm 1:routine anesthesia induction,0.1mg/kg midazolam, 3-8mcg/kg fentanyl, 0.08-0.15mg/kg vecuronium and 0.3mg/kg etomidate, Nasotracheal intubation with seeing optical shikani; Arms 2: Sevoflurane combined with oxyge, 0.3mg/kg Etomidate and 1-2mg/kg succinylcholine for intubation, nasotracheal intubation with seeing optical shikani
Sponsors
Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Elective non-cardiac surgery patients requiring intubation for the surgery. Age 18-70 ASA 1-3 Body Mass Index (BMI) \< 40
Exclusion criteria
* Patients confirmed with difficult ventilation; * Patients not suitable for nasal intubation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of the Patients With Successful Nasotracheal Intubation | 1 hour(peri-intubation time) | After anesthesia induction, the patients were undergone nasotracheal intubation with SOS. Number for first time successful intubation was recorded. If the time for one attempt intubation exceeded more than 120 seconds, it would be regarded as failed intubation for this time intubation. If a patient could not be successfully intubated after three attempts, the patients would be viewed as a case failing nasotracheal intubation with SOS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time for Nasotracheal Intubation With the Use of Shikani Optical Stylet | 1 hour (peri-intubation time) | The time of nasotracheal intubation was calculated from the SOS insertion to withdrawing the stylet from the endotracheal tube. |
Countries
China
Participant flow
Recruitment details
Patients (ASA I-III) who required general anesthesia undergoing oral and maxillofacial surgery and agreed to participate in the present study were recruited from August 2009 to November 2009 in the Second Xiangya Hospital of Central South university. All the patients have signed the consented forms for the study.
Pre-assignment details
55 patients were recruited into the study and assigned to two groups. The patients without predicted difficult intubation (n=35) were rectuited into Group A. The patients (n=20) with predicted intubation but not difficult ventilation were recruited into Group B. Two patients were excluded from the present study due to difficult ventilation.
Participants by arm
| Arm | Count |
|---|---|
| Intubation Without Difficulty Patients without anticipated difficult intubation. Anesthesia induction: Midalozlam, Fentanyl, Vecuronium; Etomidate. After that, nasotracheal intubation with Shikani optical stylet | 35 |
| Difficult Intubation The patients will be anticipated for difficult intubation without difficult ventilation. Anesthesia was induced by inhaled sevoflurane with oxygen followed by 0.3mg/kg etomidate and 1-2mg/kg succinylcholine. After induction, nasotracheal inbutation were performed with seeing optical shikani. | 20 |
| Total | 55 |
Baseline characteristics
| Characteristic | Difficult Intubation | Intubation Without Difficulty | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 35 Participants | 55 Participants |
| Age Continuous | 32.7 years STANDARD_DEVIATION 6.3 | 34.2 years STANDARD_DEVIATION 6.7 | 33.4 years STANDARD_DEVIATION 7.1 |
| Region of Enrollment China | 20 participants | 35 participants | 55 participants |
| Sex: Female, Male Female | 9 Participants | 15 Participants | 24 Participants |
| Sex: Female, Male Male | 11 Participants | 20 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 35 | 0 / 18 |
| serious Total, serious adverse events | 0 / 35 | 0 / 18 |
Outcome results
Primary
Number of the Patients With Successful Nasotracheal Intubation
After anesthesia induction, the patients were undergone nasotracheal intubation with SOS. Number for first time successful intubation was recorded. If the time for one attempt intubation exceeded more than 120 seconds, it would be regarded as failed intubation for this time intubation. If a patient could not be successfully intubated after three attempts, the patients would be viewed as a case failing nasotracheal intubation with SOS.
Time frame: 1 hour(peri-intubation time)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intubation Without Difficulty | Number of the Patients With Successful Nasotracheal Intubation | 35 participants |
| Difficult Intubation | Number of the Patients With Successful Nasotracheal Intubation | 18 participants |
Secondary
Time for Nasotracheal Intubation With the Use of Shikani Optical Stylet
The time of nasotracheal intubation was calculated from the SOS insertion to withdrawing the stylet from the endotracheal tube.
Time frame: 1 hour (peri-intubation time)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intubation Without Difficulty | Time for Nasotracheal Intubation With the Use of Shikani Optical Stylet | 26.3 seconds | Standard Deviation 6.4 |
| Difficult Intubation | Time for Nasotracheal Intubation With the Use of Shikani Optical Stylet | 27.2 seconds | Standard Deviation 8.1 |