Nasotracheal Intubation Using Shikani Optical Stylet

NCT ID: NCT00963677

Last Updated: 2012-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-11-30

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.

Conditions

Intubation; Difficult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intubation without difficulty

The patients are not predicted for difficult intubation

Group Type: EXPERIMENTAL

Nasotracheal Intubation through seeing optical stylet (SOS)

Intervention Type: PROCEDURE

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

Difficult intubation

The patients will be anticipated for difficult intubation without difficult ventilation

Group Type: EXPERIMENTAL

Nasotracheal Intubation through seeing optical stylet (SOS)

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

fluoroscopy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central South University

OTHER

Sponsor Role: lead

Responsible Party

Ru-Ping Dai

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ru-Ping Dai, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Second Xiangya Hospital of Central South University

Locations

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Countries

China

Other Identifiers

RDai-CSU

Identifier Type: OTHER

Identifier Source: secondary_id

NSFC-30700790

Identifier Type: -

Identifier Source: org_study_id