Nasotracheal Intubation Using Shikani Optical Stylet

Intubation; Difficult Clinical Trial

— SOS  

Official title:

Shikani Optical Stylet for Nasotracheal Intubation Undergoing Oral and Maxillofacial Surgery, a Prospective Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00963677
• Other study ID #: NSFC-30700790
• Secondary ID: RDai-CSU
• Status: Completed
• Phase: N/A
• First received: August 19, 2009
• Last updated: May 1, 2012
• Start date: July 2009
• Est. completion date: November 2010

Study information

• Verified date: March 2012
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intubation; Difficult

Intervention

Procedure:
• Nasotracheal 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

Locations

Country	Name	City	State
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	1 hour(peri-intubation time)	Yes
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.	1 hour (peri-intubation time)	Yes