| CTRI Number |
CTRI/2024/06/068443 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
Anaesthetic management of shared airway surgeries using THRIVE technique |
|
Scientific Title of Study
|
Anaesthetic management of otolaryngotracheal procedures using Trans Nasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE): An observational retrospective study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Minal Harde |
| Designation |
Professor |
| Affiliation |
Topiwala National Medical College |
| Address |
Department of anesthesia, Nair Hospital
Mumbai Central
Mumbai
MAHARASHTRA
400011
India |
| Phone |
09322294681 |
| Fax |
|
| Email |
minalharde@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Minal Harde |
| Designation |
Professor |
| Affiliation |
Topiwala National Medical College |
| Address |
Department of anesthesia, Nair Hospital
Mumbai Central
Mumbai
MAHARASHTRA
400011
India |
| Phone |
09322294681 |
| Fax |
|
| Email |
minalharde@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Minal Harde |
| Designation |
Professor |
| Affiliation |
Topiwala National Medical College |
| Address |
Department of anesthesia, Nair Hospital
Mumbai Central
Mumbai
MAHARASHTRA
400011
India |
| Phone |
09322294681 |
| Fax |
|
| Email |
minalharde@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Government Medical College |
|
|
Primary Sponsor
|
| Name |
TNMC and Nair Hospital |
| Address |
TNMC and BYL Nair Hospital
Mumbai, INDIA
40008 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Minal harde |
TNMC |
Department of anesthesia, Topiwala National Medical College, Nair Hospital
Mumbai Central
Mumbai
MAHARASHTRA |
9322294681
minalharde@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Academic Research Project |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All the patients who underwent otolaryngotracheal surgical procedures under anaesthesia with use of THRIVE during the study period. |
|
| ExclusionCriteria |
| Details |
All the patients who underwent otolaryngotracheal surgical procedures under anaesthesia without THRIVE during the study period. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Vital parameters Heart rate (HR), blood pressure (BP), SpO2, respiratory rate (RR), end tidal carbon dioxide (ETCO2) noted in the preoperative, intraoperative and postoperative period.
THRIVE Flow used
Intra-operative and postoperative course |
Intra-operative and postoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intra-operative and postoperative desaturation or hypercarbia, need for intubation |
Intra-operative and postoperative |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Anaesthesia for shared airway surgeries pose special challenge due to shared airway by anaesthesiologist and surgeons. Special anaesthesia techniques have been used for maintaining oxygenation & ventilation during these otolaryngotracheal surgeries. Apnoeic anaesthesia which is needed in these surgeries can be provided with various techniques and THRIVE is a recent addition to it. [1,2] Trans Nasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE) has unique applications for use during anaesthesia. THRIVE is a technique that allows delivery of upto70 litres of oxygen per minute at 37degree Celsius, with absolute humidity of 44mg H2O/L and an FiO2 up to 1. Anaesthesia for airway surgeries need special techniques owing to shared airway and higher risk of airway complications. A tubeless surgical field in a shared airway is always the preferred technique & long apnea is possible due to THRIVE maintaining oxygenation & ventilation. THRIVE avoids the need for intubation in airway surgeries and associated complications.
However being novel technique there are limited studies available and no studies published on Indian population. Hence, we decided to conduct an observational retrospective study on anaesthetic management of patients in ENT OT for various surgical procedures in which THRIVE was used. AIM Anaesthetic management of otolaryngotracheal procedures using Trans Nasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE) OBJECTIVES: To study the following parameters- Vital parameters, SPO2, ETCO2, ABG parameters, Duration of THRIVE use, Flow used, Peri-operative course, Surgical procedure and duration, Complication if any and management References.1.
Pearson KL, McGuire BE. Anaesthesia for
laryngo-tracheal surgery, including tubeless field techniques. BJA Educ. 2017;17:242–8. 2.
Jaquet Y,
Monnier P, Van Melle G, Ravussin P, Spahn DR, Chollet-Rivier M. Complications
of different ventilation strategies in endoscopic laryngeal surgery: a 10-year
review. Anesthesiology. 2006 Jan;104(1):52-9. doi:
10.1097/00000542-200601000-00010. PMID: 16394690.
3. Patel A. Nouraei SA. Transnasal Humidified
Rapid-Insufflation Ventilatory Exchange(THRIVE): a physiological method of
increasing apnoea time in patients with difficult airways. Anaesthesia
2015;70:323-9
|