Intubation in patients with Neck injury patients

Not yet recruiting

• Conditions: Spinal cord injury

• Registration Number: CTRI/2015/06/005936
• Lead Sponsor: Jawaharlal postgraduate medical education and research PG research committee

Brief Summary

A.    **Study procedure:**After approval of JIPMER scientific advisory committee, Institute Ethicscommittee, registration from CTRI. Informed written consent from patient orrelatives will be taken. A total of 180 patients meeting inclusion criteriawill be enrolled in the study and randomized into one of the 3 groups K, C, D. RegularPre-medications will be given with tablet famotidine 20 mg, diazepam 5mg in thenight the day before surgery and tablet famotidine 20mg, Perinorm 10mg,diazepam 5mg in the morning of the day of surgery. After securing IV line, connectingstandard monitors, pre-oxygenation will be done. Standard intubation protocolwill be followed by using fentanyl 2 ug/kg, propofol 2mg/kg, vecuronium0.1mg/kg. Cervical spine immobilization will be maintained by using a rigidcervical collar or manual in line stabilization and tracheal intubation will beperformed by one of these 3 video laryngoscopes following manufacturers’recommendations. Standard endotracheal tube of size 8 for the male and size 7for the female will be used for all the patients in the study.

 **B.** **Data collection methods includingsettings and periodicity:**

a)    First attempt success rate

b)    More than 2 attempts – failure ofthe intubation

c)    Time for intubation – from scopepassing teeth to tube seen passing vocal cords                                                                                                                                        Grading of intubation difficulty – modified IDS score8,9

d)     Percentage of glottic opening (POGO)score10

e)    Cormack - Lehane grading of glotticview

f)     Alternative techniques used likeBougie, External laryngeal manipulation, or Specialist needed.

g)    Ease of insertion

h)    Complications – airway trauma, esophagealintubation

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-07
• Last Update Posted: 2015-06-19

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Inclusion criteria includes adults posted for elective surgeries requiring general anesthesia with intubation, with proven/suspected cervical spinal cord injury on cervical immobilization with rigid collar.

Exclusion Criteria

Exclusion criteria includes anticipated difficult airways with any other disorders and aspiration risk, other than cervical spine injury.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
First attempt intubation success, Intubation Difficulty Score and POGO score	First attempt intubation success in percentage, Intubation Difficulty Score based on 10 point score and POGO score based on percentage of glottic opening will be recorded during endotracheal intubation

Secondary Outcome Measures

Name	Time	Method
Time for intubation,any maneuvers required	Time in seconds that is time from insertion of Videolaryngoscope to the visualization of passing of the endotracheal tube through the glottis opening

Trial Locations

Locations (1)

Jawaharlal institute of postgraduate medical education and research (JIPMER); 🇮🇳 Pondicherry, PONDICHERRY, India

Jawaharlal institute of postgraduate medical education and research (JIPMER)

🇮🇳Pondicherry, PONDICHERRY, India

Dhanyasi Shravanalaxmi

Principal investigator

9789283166

prasanna_bidkar@rediffmail.com