Nasotracheal Intubation Using Shikani Optical Stylet
Information source: Central South University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Intubation; Difficult
Intervention: Nasotracheal Intubation through seeing optical stylet (SOS) (Procedure)
Phase: N/A
Status: Completed
Sponsored by: Central South University Official(s) and/or principal investigator(s): Ru-Ping Dai, MD, PhD, Principal Investigator, Affiliation: Central South University
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.
Clinical Details
Official title: Shikani Optical Stylet for Nasotracheal Intubation Undergoing Oral and Maxillofacial Surgery, a Prospective Evaluation
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of the Patients With Successful Nasotracheal Intubation
Secondary outcome: Time for Nasotracheal Intubation With the Use of Shikani Optical Stylet
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
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
The Second Xiangya Hospital of Central South University, Changsha, Hunan 410011, China
Additional Information
Starting date: July 2009
Last updated: May 1, 2012
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