| CTRI Number |
CTRI/2019/06/019934 [Registered on: 28/06/2019] Trial Registered Prospectively |
| Last Modified On: |
27/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparing the effectiveness of two ways of mask ventilation in obese adult patients |
|
Scientific Title of Study
|
Comparative evaluation of effectiveness of two techniques of two handed mask ventilation in obese adult patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ghazala Anis Fatima |
| Designation |
Postgraduate |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology,
B L Taneja Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi
Department of Anaesthesiology,
B L Taneja Block, Maulana Azad Medical College,Bahadur Shah Zafar Marg, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
8826088453 |
| Fax |
|
| Email |
ghazalafatima08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Rani Sharma |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology,
B L Taneja Block, Maulana Azad Medical College, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9968604376 |
| Fax |
|
| Email |
drkavitadn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ghazala Anis Fatima |
| Designation |
Postgraduate |
| Affiliation |
|
| Address |
Department of Anaesthesiology,
B L Taneja Block, Maulana Azad Medical College,Bahadur Shah Zafar Marg, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
8826088453 |
| Fax |
|
| Email |
ghazalafatima08@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated Lok Nayak Hospital
Bahadur Shah Zafar Marg
New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad MEdical College, Bahadur Shah Zafar Marg, New Delhi, 110002 |
| 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 Ghazala Anis Fatima |
Lok Nayak Hospital |
Lok Nayak Hospital and Associated Hospital, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi, 110002
New Delhi
DELHI |
8826088453
ghazalafatima08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients posted for elective surgeries under general anaesthesia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
C-E technique of two handed mask ventilation |
The C-E technique applies mask by forming a "C" shape with each thumb and index finger on the body of the mask over each side of the mask while third,fourth and fifth fingers of both hands lift the mandible towards the mask in a three fingered "E" shape. |
| Comparator Agent |
Expired Tidal Volume and end tidal Carbon dioxide |
Expired tidal volume and end tidal carbon dioxide shall be recorded for 10 target breaths using both techniques |
| Intervention |
V-E technique of two handed mask ventilation |
The V-E technique uses the thumbs and the eminence of each hand placed over each side of the mask, while the second to fifth digits pull the jaw upward, again forming an "E" shape. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of American Society of Anaethesiologists physical status I/II with BMI more than or equal to 30 kilogram per squared metre |
|
| ExclusionCriteria |
| Details |
Acute and chronic respiratory disorders
Patients requiring rapid sequence intubation
Patients requiring awake intubation
Patients with dressing or scars or raw area over face
Intra oral or pharyngeal swellings or masses
Edentulous patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean expired tidal volume |
intraoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean expired tidal volume/actual weight |
intraoperatively |
| Mean expired tidal volume/predicted body weight |
intraoperatively |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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)
|
01/07/2019 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Bag mask ventilation is required in nearly all general anaesthesia patients for a certain time after induction is achieved. This basic airway management technique permits oxygenation and ventilation of a patient until a more definitive airway can be established.The principal challenge in performing a bag mask ventilation is forming an effective seal over the patient’s face. Obese patients are often difficult to mask ventilate and are also a group of patients with lower oxygen reserves and a higher rate of oxygen consumption in whom inadequate bag mask ventilation may lead to rapid oxygen desaturation. The conventional teaching of bag mask ventilation uses C-E technique which is also more popular but it is unknown whether both techniques( C-E and V-E) are attempted in practice, or if one is preferred over the other. There is a paucity of studies comparing the two handed C-E technique and V-E technique of mask holding for their effectiveness in facilitating face mask ventilation. Patients aged 18-60 years requiring general aneasthesia fulfilling inclusion/ exclusion criteria will be recruited. The subjects will be placed on the operating room table in 15 degree head up ramped position. Appropriate size pillow will be used to align the external auditory meatus and sternal notch. All standard monitors will be attached and baseline values recorded. Preoxygenation will be carried out using face mask with a flow rate of 10 liter/min of 100% oxygen until expired oxygen concentration reached ~ 80%. An intravenous bolus of injection fentanyl 2 microgram/kg according to ideal body weight (IBW) will be given before induction. Induction of anaesthesia will be achieved by an intravenous bolus injection of propofol 2-2.5 mg/kg according to IBW. After checking for ventilation IV injection vecuronium 0.1 mg/kg of IBW will be given. One minute of stabilization will be given. After apnea, depending on the group allocated, the patients will be ventilated with first mask technique. Ventilation will be obtained with the ventilator set to pressure control mode at a rate of 10 bpm, inspiratory to expiratory time ratio (I:E) 1:2, peak inspiratory pressure of 15 cm of water and no PEEP. After stabilization period of 1 minute, 10 consecutive breaths data over next one minute will be recorded. Thereafter, mask ventilation will be carried out using the second technique. one minute of stabilization time will be given and next 10 consecutive breaths will be recorded. If the mask ventilation fails with consecutive breaths, the mask ventilation technique will be changed to the other technique. If at any time, the SPO2 is less than 94% during a mask ventilation attempt, the technique will be considered as failure and it will be changed to other technique. After the study protocol is over,the airway and anaesthesia will be managed as per the requirement of the case. Expired tidal volume and end tidal carbon dioxide for each breath will be recorded. Statistical analysis will be done using Wilcoxon signed rank test or student paired t test. |