| CTRI Number |
CTRI/2019/10/021727 [Registered on: 21/10/2019] Trial Registered Prospectively |
| Last Modified On: |
21/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Airway management of oral cancer |
|
Scientific Title of Study
|
A Prospective study of airway assessment and airway management in patients with oral malignancy undergoing oncosurgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hemachander |
| Designation |
Junior resident , Department of Anaesthesiology, LTMMC |
| Affiliation |
Lokmanya Tilak Municipal Medical College and General Hospital |
| Address |
Department of Anaesthesiology, Lokmanya Tilak Municipal Medical college and General Hospital, Sion, Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
8056651048 |
| Fax |
|
| Email |
hemachander1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amala kudalkar |
| Designation |
Professor, Department of Anaesthesiology, LTMMC |
| Affiliation |
Lokmanya Tilak Municipal Medical College and General Hospital |
| Address |
Department of Anaesthesiology, Lokmanya Tilak Municipal Medical college and General Hospital, Sion, Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9869134209 |
| Fax |
|
| Email |
akudalkar20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemachander |
| Designation |
Junior resident , Department of Anaesthesiology, LTMMC |
| Affiliation |
Lokmanya Tilak Municipal Medical College and General Hospital |
| Address |
Department of Anaesthesiology, Lokmanya Tilak Municipal Medical college and General Hospital, Sion, Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
8056651048 |
| Fax |
|
| Email |
hemachander1993@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lokmanya Tilak Municipal Medical College and General Hospital |
|
|
Primary Sponsor
|
| Name |
Lokmanya Tilak Municipal Medical College and General Hospital |
| Address |
Department of Anaesthesiology
Lokmanya Tilak Municipal Medical College and General Hospital Sion Mumbai |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hemachander |
Lokmanya Tilak Municipal Medical College and General Hospital |
Department of Anesthesiology,
Lokmanya Tilak Municipal Medical College and General Hospital Sion Mumbai 400022
Mumbai
MAHARASHTRA |
8056651048
hemachander1993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Human research- Lokmanya Tilak Municipal Medical College and General Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C009||Malignant neoplasm of lip, unspecified, (2) ICD-10 Condition: C029||Malignant neoplasm of tongue, unspecified, (3) ICD-10 Condition: C059||Malignant neoplasm of palate, unspecified, (4) ICD-10 Condition: C049||Malignant neoplasm of floor of mouth, unspecified, (5) ICD-10 Condition: C060||Malignant neoplasm of cheek mucosa, (6) ICD-10 Condition: C060||Malignant neoplasm of cheek mucosa, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-65 years
Both genders
Patients with Oral Malignancy undergoing Oncosurgery |
|
| ExclusionCriteria |
| Details |
Unwilling to give consent |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
1.Preoperative evaluation of airway
2.To determine factors associated with difficult intubation.
3.To study the predictive value of El Ganzouri risk index for determination of difficult intubation.
4.To study methods of induction of anesthesia and securing of airway
|
During pre-op evaluation
During induction
During intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the Extubation method used
2.To study Airway related complications |
During Induction
During Intubation
During Extubation |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/10/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
After IEC Permission, patients scheduled for the oral surgery under general anaesthesia and satisfying all inclusion criteria will be included into the study. All patients will be explained about the study and a written valid informed consent for their willingness to participate in the study will be taken. A standard OT protocol for routine pre anaesthetic checkup will be followed. Preoperative Airway Assessment related to oral malignancy : History: â— Duration of oral malignancy â— Rapidity of growth of the oral malignancy: It may indicate either hemorrhage or rapidly enlarging malignancy â— H/o teeth trouble/loose tooth â— H/o difficulty in swallowing and breathing â— H/o bleeding from the swelling â— Past H/o previous oral surgeries H/o difficult intubation in the past â— H/o Postoperative ventilator stay â— H/o Radiation therapy Examination: A thorough airway examination will be done â— Mouth opening : inter incisor gap â— Mallampatti classification â— Thyromental distance â— Neck movement â— Ability to prognath Will be checked. In addition â— Extent of oral swelling Fixation of tongue to the floor of mouth â— Nasal patency â— Signs of airway distress- dyspnea, tachypnea, accessory muscles usage EL GANZOURI RISK INDEX Variable Findings Points Mouth opening >4 cm 0 < 4 cm 1 Thyromental distance >6.5 cm 0 6-6.5 cm 1 <6cm 2 Mallampati score I 0 II 1 III IV 2 Neck movement >90 0 80-90 1 <80 2 Ability to prognath yes 0 no 1 Body weight <90 kg 0 90-110 kg 1 >110 kg 2 History of difficult intubation None 0 questinable 1 definite 2 , All hematological and biochemical investigations will be done as per OT protocol. Chest X ray (PA view), ECG , and ABG will be noted in all patients . In addition, findings of CT scan or MRI of the head and neck will be note to delineate the exact location and extension. Anesthesia Technique will be at the discretion of the consultant anesthesiologist. The technique followed in each case will be observed and noted. Which technique is used for intubation of trachea : They can be broadly divided into Intubation after anesthetizing patient: â— Which anesthetic agent was used: intravenous or inhalational â— Which muscle relaxant was used for intubation. â— Specialized airway equipment kept ready and used will be noted. â— The commonly used equipment are intubating bougie, flexitip laryngoscope, video laryngoscopes such as King vision, Airtraq. Also supraglottic airway devices for emergency access to airway are kept ready. Awake Intubation after anesthetizing airway â— After direct laryngoscopy â— Fiber optic laryngoscope with endotracheal tube mounted on it, Type of tube used and size will be noted. â— The commonly used endotracheal tubes are PVC endo-tracheal tube. Flexo-metallic tube. The position of tube placement will be confirmed by Capnography. Airway Complications during tracheal intubation will be noted: The common complications include: â— Airway trauma such as injury to teeth, lips, tongue, tonsillar pillars and vocal cords â— Partial or complete obstruction accompanied by varying degrees of hypoxemia and hypercapnia â— Desaturation In addition, Hemodynamic instability if any will be noted The standard intraoperative Monitoring done is ECG , pulse, blood pressure, oxygen Saturation, ETCO2, peak airway pressure, temperature, filling pressure , blood loss and urine output At the end of surgery , the patient will be either reversed and extubated or shifted on ventilator as per the discretion of the attending anaesthesiologist . If not extubated, reason of not extubation be noted . Following parameters will be noted for extubation : i) Time of extubation ii) Method of extubation iii) Use of any special gadget for extubation iv) Complication if any |