| CTRI Number |
CTRI/2025/08/093715 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
23/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing two different types of laryngoscopic blades in patients undergoing general anaesthesia. |
|
Scientific Title of Study
|
Laryngoscopic glottic view with miller vs macintosh blade in adults posted for surgery under general anaesthesia:a randomized controlled 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 |
Sai Preetham Reddy |
| Designation |
Post Graduate Trainee |
| Affiliation |
Kalinga Institute of Medical Sciences. |
| Address |
Kalinga institute of medical sciences,Department of anaesthesia,3rd floor,main building,Patia,Bhubaneswar.
Khordha
ORISSA
751024
India |
| Phone |
8919746857 |
| Fax |
|
| Email |
preethamreddy8888@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR LINGARAJ SAHU |
| Designation |
PROFESSOR |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES. |
| Address |
Department of Anaesthesiology, Kalinga institute of medical sciences, third floor. Bhubaneswar, Odisha
Khordha
ORISSA
751024
India |
| Phone |
8280166501 |
| Fax |
|
| Email |
lingaraj.sahu@kims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR LINGARAJ SAHU |
| Designation |
PROFESSOR |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES. |
| Address |
Department of Anaesthesiology, Kalinga institute of medical sciences, third floor. Bhubaneswar, Odisha
Khordha
ORISSA
751024
India |
| Phone |
8280166501 |
| Fax |
|
| Email |
lingaraj.sahu@kims.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sai Preetham reddy |
| Address |
Kalinga institute of medical sciences,Department of anaesthesiology,3rd floor,main building,PATIA,BHUBANESWAR |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Sai Preetham Reddy |
Pradyuman Bal Memorial Hospital,Kalinga institute of medical sciences. |
Department of Anaesthesia ,kalinga institute of medical sciences,bhubaneswar,751024,khordha,orissa.
Khordha
ORISSA |
8919746857
preethamreddy8888@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE KALINGA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z409||Encounter for prophylactic surgery, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LARYNGOSCOPIC BLADES |
50 patients will be intubated using mailler blade,and rest 50 patients will be intubated uisng macintosh blade. |
| Comparator Agent |
LARYNGOSCOPIC BLADES |
To compare the cormack-lehane grading between miller and macintosh blades. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Age 18-60 years
2)American society of Anaesthesiology(ASA)physical status 1&2.
3)Willing patients posted for elective surgery requiring general anaesthesia. |
|
| ExclusionCriteria |
| Details |
1)Patients with anticipated difficult airway(Mallampati grade 3&4,inadequate neck extension,mouth opening less than 3 fingers).
2)Patients requiring rapid sequence induction. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the cormack-lehane grading obtained through miller and macintosh blades. |
During the time of intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the ease of intubation,number of attempts,time required for intubation,manipulation requirement,bougie requirement. |
During the time of intubation. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
11/09/2025 |
| 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="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
|
Appropriate laryngoscopic view decreases laryngoscopy time and hence intubation reflex. This
increases safety margin for the patient, various types of laryngoscope and techniques of
laryngoscopy have been used for securing the endotracheal tube. The standard curved
Macintosh blade is preferred by anaesthesiologists in routine intubations. This laryngoscope
has the advantage of allowing more room in the oropharynx for manipulation of the
endotracheal tube; however poor visualization of the larynx is often encountered problem
because the blade interferes with the line of sight of larynx especially in patients with decreased
space in oral cavity. With macintosh blade it is not always possible to manipulate the entire
tongue to left, leading to compression of base of tongue and posterior displacement of
epiglottis, which leads to decreased view of vocal cords. In such situations miller straight
blade have been found beneficial because there is less tissue volume present in the oropharynx
to be displaced and reduced tongue compression as compared with the macintosh
blade.Till now there are limited
studies available comparing the two blades with regard to laryngoscopic view and ease of
intubation. Hence a prospective comparative study will be undertaken to evaluate the
laryngoscopic view and ease of intubation with both the aforementioned blades in routine
tracheal intubations. |