| CTRI Number |
CTRI/2020/07/026730 [Registered on: 22/07/2020] Trial Registered Prospectively |
| Last Modified On: |
19/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
STUDY COMPARING THE EFFICACY OF PREOXYGENATION DONE PRIOR TO ANAESTHESIA IN LYING DOWN VERSUS HEAD UP POSITIONS IN PATIENTS UNDERGOING ELECTIVE ONCOSURGERIES†|
|
Scientific Title of Study
|
STUDY COMPARING THE EFFICACY OF PREOXYGENATION IN SUPINE VERSUS HEAD UP POSITIONS IN PATIENTS UNDERGOING ELECTIVE ONCOSURGERIES†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR NEHALI B MAIYA |
| Designation |
POST GRADUATE MD ANAESTHESIOLOGY |
| Affiliation |
KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY
BANGALORE
#6, 7th main, 8th cross
chikkadugodi
bangalore- 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
8050887886 |
| Fax |
|
| Email |
nehalimaiya13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NAMRATA RANGANATH |
| Designation |
HOD AND PROFESSOR |
| Affiliation |
KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY
BANGALORE
Bangalore
KARNATAKA
560029
India |
| Phone |
9880642830 |
| Fax |
|
| Email |
namrang@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NEHALI B MAIYA |
| Designation |
POST GRADUATE MD ANAESTHESIOLOGY |
| Affiliation |
KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY
BANGALORE
#6, 7th main, 8th cross
chikkadugodi
bangalore- 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
8050887886 |
| Fax |
|
| Email |
nehalimaiya13@gmail.com |
|
|
Source of Monetary or Material Support
|
| KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY
DR MH MARIGOWDA ROAD
BANGALORE-560029 |
|
|
Primary Sponsor
|
| Name |
KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY |
| Address |
KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY
DR MH MARIGOWDA ROAD
BANGALORE-560029 |
| 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 Nehali B Maiya |
Kidwai Memorial Institute of Oncology |
DR MH MARIGOWDA ROAD
BANGALORE-560029
Bangalore
KARNATAKA |
8050887886
nehalimaiya13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Scientific Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D015||Carcinoma in situ of liver, gallbladder and bile ducts, (2) ICD-10 Condition: C437||Malignant melanoma of lower limb,including hip, (3) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (4) ICD-10 Condition: C480||Malignant neoplasm of retroperitoneum, (5) ICD-10 Condition: C400||Malignant neoplasm of scapula andlong bones of upper limb, (6) ICD-10 Condition: C187||Malignant neoplasm of sigmoid colon, (7) ICD-10 Condition: C629||Malignant neoplasm of testis, unspecified whether descended or undescended, (8) ICD-10 Condition: C73||Malignant neoplasm of thyroid gland, (9) ICD-10 Condition: C55||Malignant neoplasm of uterus, partunspecified, (10) ICD-10 Condition: C64-C68||Malignant neoplasms of urinary tract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
preoxygenation in head up positions |
to place the patients in supine, 25 degree head up , 45 degree head up possitions for preoxygenation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged >18 years and <50 years
2. ASA 1 & 2
3. With BMI ranging from 18kg/m2 to 25 kg/m2
4. Requiring oral intubation
5. Non smoker
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Significant cardiorespiratory or systemic disease
3. Anticipated difficult intubation and history of difficult intubation
4. Those requiring rapid sequence induction
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of preoxygenation in terms of duration of apnoea time in supine versus 25 degree and 45 degree position in patients undergoing elective oncosurgeries |
To look for apnoea time when SpO2 drops below 95% |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the hemodynamic variability in supine, 25 degree and 45 degree head up positions during our study period |
immediately after preoxygenation, 3mins, 6mins, 9mins, 15 mins after that |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/07/2020 |
| Date of Study Completion (India) |
31/10/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/10/2021 |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
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)?
|
Brief Summary
Modification(s)
|
Preoxygenation, which is a routine administration of 100% oxygen to the conscious patients before the induction of anaesthesia, increases the oxygen reserve and duration of apnoea without significant desaturation.Building up of oxygen reserves assumes a greater significance as this provides a longer duration of non-hypoxic apnoea should one face an unanticipated difficult airway Apnoea following administration of an induction agent or a neuromuscular blocker can lead to fall in arterail oxygenation with SpO2 as low as 88% in healthy patients breathing air before induction. preoxygenation increases the oxygen reserve from 1.2litres prior to oxygenation to 4.8 litres at the end of 3 mins. Thus, it is proved that arterial desaturation during apnea is delayed in such patients if induction of anesthesia is accomplished in the head-up position (250,450). Hence we wanted to study and compare the effect of preoxygenation in supine and two
different angles 25degree, and 45 degree and assess which group provides the prolonged apnoea time without compromising patient safety. |