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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

Page last updated: August 23, 2015

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