We are going to compare 2 techniques for oxygen tube insertion through nose with the help of C mac D video laryngoscope in patients undergoing oral cancer surgeries.
- Conditions
- Neoplasms,
- Registration Number
- CTRI/2020/07/026787
- Lead Sponsor
- Shree krishna hospital
- Brief Summary
The study is planned on patients undergoing oro facial malignancy surgeris comparing 2 techniques for nasotracheal intubation using C mac D blade video laryngoscope after informed consent of the participants and approval of the hospital ethics committe.Patients will be randomized in 2 groups as per the balanced randomization process (WINPEPI software).The two groups will be Group M (use of magill’s forceps) and Group C (use of cuff inflation technique). Nasotracheal intubation (NTI) is the choice of airway management for oro-facial malignancy surgeries in order to enable access to the surgical field. In patients with restricted mouth opening, ï¬breoptic bronchoscope-guided NTI is the gold standard. Fibreoptic bronchoscope-guided intubation requires training, has a learning curve , is costly (especially for developing world), may not be feasible in the presence of bleeding from a tumor mass, and may not be available everywhere. Other options include blind nasal intubation or nasal intubation guided by a conventional laryngoscope. Blind nasal intubation is a dying art, has a high failure rate, requires expertise, and is not a safer option for cancer patients because of the risk of trauma and bleeding.Recently, video laryngoscopes (VL) have played an important role in airway management in unanticipated difficult or failed endotracheal intubations. Video laryngoscope (Glide scope or C mac D blade VL) can be inserted into oral cavity in patients if mouth opening (>=2.5 cm) is sufficient for insertion of VL. It is already proven that C-Mac D blade video laryngoscope is better than conventional Macintosh laryngoscope for nasotracheal intubation in patients with difficult airway like oro - facial malignancies. Nasotracheal intubation required for surgical access during oro-facial malignancy surgeries may be challenging due to the presence of, oedema / swelling causing deformities of facial and pharyngeal structures in addition to the other common causes of difficult intubations.ThusVideo laryngoscope(VL) is indicated in all difficult airway cases – where the mouth opening (inter incisor gap) is restricted to, 1.5-3 cms or in presence of altered anatomy as in malignancy of head face and Neck where conventional laryngoscopy might cause trauma due to alignment of oral -tracheal and pharyngeal axis for visualisation of glottic aperture. The VL does not need such alignment as the camera at the tip provides an image of the glottic aperture on the screen(Indirect laryngoscopy)
Successful laryngoscopy using a video laryngoscope does not always guarantee advancement of the tube in the trachea. Correct placement of the tube can be challenging and may require use of different techniques. Use of Magill’s forceps and Endotracheal tube cuff inflation technique have been described . We plan this study to compare these two techniques during video laryngoscopy to improve the success of nasotracheal intubation in orofacial malignancy surgeries. Glottic view in terms of Cormack-Lehane grade obtained on first view of the monitor, ease of intuba1tion, number of attempts, hemodynamic changes, total duration required for intubation and any other complications like desaturation, mucosal bleeding or dental trauma during the procedure will be the parameters which will be assessed in the studyWe were not able to find such type of a study in the literature comparing the two above mentioned techniques of achieving endotracheal intubation nasally in orofacial malignancies using the video .laryngoscope.Descriptive statistics will be used to depict the profile of participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 52
- Patients scheduled for orofacial cancer surgeries requiring nasal intubation who fall under following criteria; 1. American Society of Anesthesiologists (ASA) class I–III 2. Age 18–70 years 3. El Ganzouri risk index (EGRI – total) between 1 – ≤ 7 will be included in our study. Difficult airway is graded by EGRI for difficult airway prediction based on seven parameters:.
- body weight [kg], modified Mallampati class, mouth opening [cm], Thyromental distance [cm], neck movement [°], prognathism, and history of difficult airway; with a score ranging from 0 to 12 will be used in our study [Table 1] Table 1: El-Ganzouri risk index Variable Finding Variable FindingPoints 1.Mouth opening(cm)>40 <41 2.Thyromental distance(cm) >6.50 6.0-6.51 <6.02 3.Mallampati score I0 II1 III2 4.Neck movement( Ⱐ) >900 80-901 <802 5.Ability to PrognathYes0 No1 6.Body weight ( Kg) <900 90-1101 >1102 7.History of difficult intubation None0 Questionable1 Definite2.
- ASA IV patients, 2.
- Patients with mouth opening <1.5 cm, 3.
- Patients with hyperkalemia, 4.
- Patients with history or family history of malignant hyperthermia, 5.
- Patients with facial trauma.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method This research project will help to evaluate the two techniques in terms of the time taken in seconds,attempts in number and ease for successful nasotrachel intubation using c mac d blade video laryngoscope in a difficult airway of oro facial malignancy cases posted for surgery.Outcome will be assessed after collecting data from estimated sample size or within 14 months/56 weeks whichever is earlier. This research project will help to evaluate the two techniques in terms of the time taken in seconds for successful intubation,attempts in number and ease for successful nasotrachel intubation using c mac d blade video laryngoscope in a difficult airway of oro facial malignancy cases posted for surgery. Outcome will be assessed after collecting data from estimated sample size or within 14 months/56 weeks whichever is earlier.
- Secondary Outcome Measures
Name Time Method This research project will help to evaluate the two techniques in terms various complications like hemodynamic changes,desaturation and trauma to teeth and other laryngeal structures for successful nasotrachel intubation using c mac d blade video laryngoscope in a difficult airway of oro facial malignancy cases posted for surgery.Outcome will be assessed after collecting data from estimated sample size or within 14 months/56 weeks whichever is earlier. This research project will help to evaluate the two techniques in terms various complications like hemodynamic changes,desaturation and trauma to teeth and other laryngeal structures for successful nasotrachel intubation using c mac d blade video laryngoscope in a difficult airway of oro facial malignancy cases posted for surgery.Outcome will be assessed after collecting data from estimated sample size or within 14 months/56 weeks whichever is earlier.
Trial Locations
- Locations (1)
Pramukh Swami Medical College, Shree Krishna hospital, Karamsad
🇮🇳Anand, GUJARAT, India
Pramukh Swami Medical College, Shree Krishna hospital, Karamsad🇮🇳Anand, GUJARAT, IndiaDr Hemlata V KamatPrincipal investigator9909929422hemlatavk@charutarhealth.org