| CTRI Number |
CTRI/2025/03/083448 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparing two techniques of face mask holding, C-E vs C-ARM |
|
Scientific Title of Study
|
Comparison of modified C-E (C-ARM) facemask holding technique with conventional C-E facemask holding technique in adult patients by novice practitioners – A Prospective Randomized Triple Blinded Crossover trial. |
| 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. Anusha Reddy Jambula |
| Designation |
Post graduate |
| Affiliation |
All India institute of medical sciences, Mangalagiri |
| Address |
Room No 1055, MOT complex, Department of anesthesiology, AIIMS, Mangalagiri, Andhra Pradesh, India.
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9505160222 |
| Fax |
|
| Email |
jambulamanasa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tangirala Nageswar Rao |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Mangalagiri |
| Address |
Room No 1055, MOT complex, Department of Anesthesiology, AIIMS Mangalagiri, Guntur, Anshra Pradesh, India.
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9959949121 |
| Fax |
|
| Email |
nag947@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Anusha Reddy Jambula |
| Designation |
Post graduate |
| Affiliation |
All India institute of medical sciences, Mangalagiri |
| Address |
Room no 1055, MOT complex, Department of Anesthesiology, AIIMS, Mangalagiri, Andhra Pradesh, India.
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9505160222 |
| Fax |
|
| Email |
jambulamanasa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No 1055, MOT complex, Department of Anaesthesiology, AIIMS, Mangalagiri, Andhra Pradesh, India, pincode: 522503 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Mangalagiri |
| Address |
All India Institute of Medical Sciences, Mangalagiri, Guntur, Andhra Pradesh, India, pincode 522503 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Anusha reddy Jambula |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, MANGALAGIRI |
Room no 1055, 1st floor, MOT Complex, Department of Anesthesiology, All India Institute of Medical Sciences, mangalagiri, Andhra Pradesh, India, 522503.
Guntur
ANDHRA PRADESH |
9121802044
jambulamanasa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Mangalagiri |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
C-ARM technique of face mask holding |
In C-ARM technique of face mask holding, during bag and mask ventilation of patients, thumb and index finger forms a C while little finger is put on angle of mandible (A) providing jaw thrust, ring finger on ramus (R) and middle finger on mentum(M) providing head tilt and chin lift. |
| Comparator Agent |
C-E technique of face mask holding |
In C-E technique of face mask holding, during bag and mask ventilation, thumb and index finger forms a C while middle, ring and little finger form an E holding the jaw up. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled for elective surgery requiring general anaesthesia American Society of Anesthesiologist Physical Status (ASA PS) I & II |
|
| ExclusionCriteria |
| Details |
History of respiratory failure or significant pulmonary diseases Severe cardiovascular comorbidities
Patients with difficult airway with facial anomalies
Risk of regurgitation and aspiration
Pregnant and psychiatry patients
Mallampati grade 3 and 4
Edentulous
Limited neck & temporomandibular joint mobility
Large Beard
Obstructive sleep apnea
Body mass index more than 30kg/m2
Comet tail (air) on 1st gastric USG
Leak more than or equal to 1ml/kg during mask holding |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Peak airway pressure
Set tidal volume
End tidal carbon dioxide
Change in tidal volume (Delta vt)
|
Baseline
5 seconds
10 seconds
15 seconds
20 seconds
25 seconds
30 seconds
35 seconds
40 seconds
45 seconds
50 seconds
55 seconds
60 seconds.
for each technique. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comfortability of novice practitioner using 5 point likert scale |
At the end of completion of both the techniques |
| visible chest rise |
Baseline
5 seconds
10 seconds
15 seconds
20 seconds
25 seconds
30 seconds
35 seconds
40 seconds
45 seconds
50 seconds
55 seconds
60 seconds.
for each technique. |
| Presence of air in the stomach using ultrasonography |
Baseline
5 seconds
10 seconds
15 seconds
20 seconds
25 seconds
30 seconds
35 seconds
40 seconds
45 seconds
50 seconds
55 seconds
60 seconds.
for each technique. |
| Oxygen Saturation (Spo2) |
Baseline
5 seconds
10 seconds
15 seconds
20 seconds
25 seconds
30 seconds
35 seconds
40 seconds
45 seconds
50 seconds
55 seconds
60 seconds.
for each technique. |
| Length between the mentum to angle of the mandible of both sides |
Baseline |
| Novice parameters (Age, Gender, Dominant hand, hand used, length between thumb tip to little finger tip on full expansion) |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
01/04/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
- Bag mask ventilation (BMV) has been used routinely for oxygenation and ventilation during induction of anaesthesia, in emergency departments, during transportation of patients by the paramedical staff and especially in cardiopulmonary resuscitation. During emergency situations, the primary care givers might be with less experience to provide the airway care, when anaesthesiologist is not available readily. That’s why all healthcare providers should master the art of BMV. After general anaesthesia the tone of the oral and pharyngeal muscle tone reduces leading to collapse of the tongue, soft palate and epiglottis. An improperly placed fingers especially middle and ring, over the submandibular soft tissue, can compress the upper airway and may lead to obstruction in anesthetized and unconscious apnoeic patients. To bypass the obstruction adjustable pressure level valve will be closed high, which further can lead to gastric insufflation. Therefore we suggest C - ARM, where little finger is placed at the Angle (A), 4th finger over the Ramus (R) and 3rd finger over Mentum (M) of the mandible. This will eliminate the soft tissue compression and airway obstruction by precisely placing the fingers over the mandible and chin lift provided with 3rd finger. It is also easier to remember C – ARM acronym, for novice practitioners.
|