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CTRI Number  CTRI/2021/12/038382 [Registered on: 02/12/2021] Trial Registered Prospectively
Last Modified On: 16/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Evaluation of type of airway and ventilatory management technique on clinical outcome in patients undergoing surgery for oral cavity cancer 
Scientific Title of Study   Clinical Outcome of Perioperative Airway and Ventilatory Management in Patients undergoing Surgery for Oral Cavity Cancer - a Prospective, Observational Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Souvik Mukherjee 
Designation  Academic Senior Resident 
Affiliation  All India Institute of Medical Sciences, Bhopal 
Address  Department of Anaesthesiology and Critical Care, AIIMS Bhopal, Saket Nagar, Bhopal-462020

Bhopal
MADHYA PRADESH
462020
India 
Phone  9831829629  
Fax    
Email  suavesouvik@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vaishali Waindeskar 
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences, Bhopal 
Address  Department of Anaesthesiology and Critical Care, AIIMS Bhopal, Saket Nagar, Bhopal-462020

Bhopal
MADHYA PRADESH
462020
India 
Phone    
Fax    
Email  vaishaliwaind@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Souvik Mukherjee 
Designation  Academic Senior Resident 
Affiliation  All India Institute of Medical Sciences, Bhopal 
Address  Department of Anaesthesiology and Critical Care, AIIMS Bhopal, Saket Nagar, Bhopal-462020
Department of Anaesthesiology and Critical Care, AIIMS Bhopal, Saket Nagar, Bhopal-462020
Bhopal
MADHYA PRADESH
462020
India 
Phone  9831829629  
Fax    
Email  suavesouvik@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Bhopal 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Bhopal 
Address  Department of Anaesthesiology and Critical Care, AIIMS Bhopal, Saket Nagar, Bhopal-462020 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Souvik Mukherjee  All India Institute of Medical Sciences, Bhopal  Department of Anaesthesiology and Critical Care, AIIMS Bhopal, Saket Nagar, Bhopal-462020
Bhopal
MADHYA PRADESH 
9831829629

suavesouvik@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee - Post Graduate Research, AIIMS Bhopal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (2) ICD-10 Condition: C029||Malignant neoplasm of tongue, unspecified, (3) ICD-10 Condition: C039||Malignant neoplasm of gum, unspecified, (4) ICD-10 Condition: C049||Malignant neoplasm of floor of mouth, unspecified, (5) ICD-10 Condition: C059||Malignant neoplasm of palate, unspecified, (6) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified, (7) ICD-10 Condition: C109||Malignant neoplasm of oropharynx,unspecified, (8) ICD-10 Condition: C12||Malignant neoplasm of pyriform sinus, (9) ICD-10 Condition: C139||Malignant neoplasm of hypopharynx,unspecified, (10) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Patients 18-65 years of age
2) Patients with ASA I-III
3) Patients undergoing oral cavity oncosurgeries under general anaesthesia 
 
ExclusionCriteria 
Details  1)Patients where surgery did not proceed
2) Patients who could not be followed up 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Description of frequency and type of procedures used in establishing a secure airway during oral cavity oncosurgical procedures as well as the duration and type of ventilatory support needed by the patients in the postoperative period  From perioperative period till end of ICU/HDU stay 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluation of effect of airway and ventilatory management techniques on postoperative length of ICU/HDU stay  From perioperative period till end of ICU/HDU stay 
Comparison of data with findings of the TRACHY study  From perioperative period till end of ICU/HDU stay 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/12/2021 
Date of Study Completion (India) 31/12/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/12/2022 
Estimated Duration of Trial   Years="1"
Months="0"
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)?  

Response - NO
Brief Summary
Modification(s)  
Cancer of the oral cavity is a heterogeneous group of pathologies. Oral cancers may have origin from various sites such as the lip, floor of the mouth, tongue, alveolar ridge, retromolar gingiva, hard palate, and buccal mucosa. 

Globally, oral cancers have a high incidence among all malignancies. In India almost 30% of newly detected malignancies annually are due to oral cancers. 

Surgery is the preferred modality of initial treatment in locoregionally advanced oral cavity cancers. Malignant involvement of the oral cavity often poses a challenge to the anaesthesiologist. Oral cancer patients commonly present with ‘difficult airway’ which is conventionally defined as ‘the clinical situation in which a conventionally trained anaesthesiologist experiences difficulty with facemask ventilation of the upper airway, difficulty with tracheal intubation, or both’. Factors responsible include distortion of upper airway anatomy by tumour, decreased inter-incisor gap, and fixation of soft tissue of upper airway by surgical scarring or fibrosis. Prior radiation therapy might lead to restricted mouth opening and limited neck movements. Routine methods of airway management during general anaesthesia are usually not sufficient in such patients. 

 Apart from difficult airway, other concerns include shared airway, prolonged surgery and postoperative airway oedema. 

A detailed assessment of airway is of prime importance in oral cancer patients both in the pre-anaesthetic checkups as well in the pre-operative setting. Careful planning and execution would reduce perioperative morbidity and length of hospital stay. 

In this study, we aim to describe the frequency and type of procedures used in establishing a secure airway, and the duration and type of postoperative ventilatory support needed by the patients undergoing surgery for oral cancers. We also aim to observe the effect of airway management techniques on the immediate clinical outcome by assessing the length of postoperative intensive care unit stay. A study to this effect would allow us to better evaluate and manage such patients and predict outcomes in the perioperative period. Hence this study has been planned
 
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