| 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 |
|
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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 |
|
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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 |
| 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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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, |
|
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Intervention / Comparator Agent
|
|
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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 |
|
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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 |
|
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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 |