Clinical trial NCT00963677: Nasotracheal Intubation Using Shikani Optical Stylet
Official title: Shikani Optical Stylet for Nasotracheal Intubation Undergoing Oral and Maxillofacial Surgery, a Prospective Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult
Keywords: Shikani optical stylet(SOS)
difficult airways
intubation
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2009-08-21
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of the Patients With Successful Nasotracheal Intubation
timeFrame: 1 hour(peri-intubation time)
Secondary outcomes:
measure: Time for Nasotracheal Intubation With the Use of Shikani Optical Stylet
timeFrame: 1 hour (peri-intubation time)
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Central South University
name: Ru-Ping Dai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: