| CTRI Number |
CTRI/2024/12/078586 [Registered on: 26/12/2024] Trial Registered Prospectively |
| Last Modified On: |
21/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare which type of laryngoscope ( Macintosh versus BPL Video laryngoscope) will help in faster nasal intubation with less complication using cuff inflation technique in adult patients |
|
Scientific Title of Study
|
A prospective study to compare the intubation conditions for nasotracheal intubation with standard direct macintosh laryngoscope versus BPL video laryngoscope using cuff inflation technique in adult patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhananjay Nivrutti Dhasade |
| Designation |
Resident doctor |
| Affiliation |
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
2nd floor General Ot Complex Anaesthesia Department, Dhiraj
Hospital
Smt. Bhikiben Kanjibhai Shah Medical Institute and
Research Centre
sumandeep vidyapeeth wagodhia pipariya vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9768487569 |
| Fax |
|
| Email |
dhananjay.dhasade@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sara Mary Thomas |
| Designation |
Professor Head of the department |
| Affiliation |
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
2nd floor General Ot Complex Anaesthesia Department, Dhiraj
Hospital
Smt. Bhikiben Kanjibhai Shah Medical Institute and
Research Centre
sumandeep vidyapeeth wagodhia pipariya vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9646500158 |
| Fax |
|
| Email |
sara.cinosh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sara Mary Thomas |
| Designation |
Professor Head of the department |
| Affiliation |
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
2nd floor General Ot Complex Anaesthesia Department, Dhiraj
Hospital
Smt. Bhikiben Kanjibhai Shah Medical Institute and
Research Centre
sumandeep vidyapeeth wagodhia pipariya vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9646500158 |
| Fax |
|
| Email |
sara.cinosh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre Wagodhia , Pipariya, Vadodara, Gujarat , India Pincode- 391760 |
|
|
Primary Sponsor
|
| Name |
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Wagodhia , Pipariya, Vadodara, Gujarat , India Pincode- 391760 |
| Type of Sponsor |
Private medical college |
|
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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 |
| Dhananjay Dhasade |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
2nd floor General Ot Complex Anaesthesia Department, Dhiraj
Hospital
Smt. Bhikiben Kanjibhai Shah Medical Institute and
Research Centre
sumandeep vidyapeeth wagodhia pipariya vadodara 391760
Vadodara
GUJARAT |
9768487569
dhananjay.dhasade@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SUMANDEEP VIDYAPEETH INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
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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 |
| Intervention |
Nasotracheal Intubation using non-channelled blade of BPL Video laryngoscope with cuff inflation technique
|
Patients were intubated nasotracheally using non-channelled blade of BPL Video laryngoscope with cuff inflation technique under general anaesthesia . The total duration of nasotracheal intubation (T) , haemodynamic parameters including the heart rate (HR), oxygen Saturation (SpO2),systolic blood pressure (SBP), diastolic blood pressure (DBP), will be noted at the baseline, after intubation and at 1,3, 5, 7 and 10 min after intubation, CL grading, the total numbers of attempts,use of assistance like external laryngeal manipulation, Magill forceps |
| Comparator Agent |
Nasotracheal Intubation using standard macintosh laryngoscope with cuff inflation technique |
Patients were intubated nasotracheally using standard macintosh laryngoscope with cuff inflation technique under general anaesthesia . The total duration of nasotracheal intubation (T) , haemodynamic parameters including the heart rate (HR), oxygen Saturation (SpO2),systolic blood pressure (SBP), diastolic blood pressure (DBP), will be noted at the baseline, after intubation and at 1,3, 5, 7 and 10 min after intubation, CL grading, the total numbers of attempts,use assistance like external laryngeal manipulation and the use of Magill forceps |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients willing to sign informed consent.
2.Male or female patients between ages of 18 to 60 years.
3.Patients belonging to American Society of Anaesthesiologists (ASA) physical status I and II.
4. Patients posted for elective surgeries requiring nasal intubation under general anaesthesia.
5. Patient having mouth opening more than 3cm
6. Patient with Malampatti grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
1. Patients unwilling to participate in the study.
2. Patients belonging to American Society of Anaesthesiologists (ASA) physical status III and IV
3. Patients having contraindication to nasal intubation. Eg. nasal polyps,nasal bone fracture,mass in nasal cavity.
4. Patient having mouth opening less than 3cm.
5. Patient with Mallampati grade 3 and 4 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This prospective study will enable us to understand which laryngoscopy is superior , hemodynamically stable and total duration for intubation , attempts for successful intubation and also have less incidence of complications. |
T1 (seconds) time taken for ETT introduction from selected nostril to oropharynx ,T2 (seconds) for laryngoscopy till passage of ETT into the vocal cords is noted. Heart rate (HR), oxygen Saturation (SpO2),systolic blood pressure (SBP), diastolic blood pressure (DBP) will be noted at baseline, after intubation ,at 1,3, 5, 7 and 10 minutes after intubation. Cormack-Lehane grading grading, numbers of attempts,assistance like external laryngeal manipulation (ELM) or Magill forceps will be noted |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
To understand which laryngoscopy with cuff inflation technique have less incidence of complications like Sore throat
Post operative complications like Nasal/oral bleeding ,
Hoarseness of voice. |
patient will be assessed for complications after extubation for next 24 hours |
|
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Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
05/01/2025 |
| 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="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
|
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Brief Summary
|
Randomized prospective study will be conducted in department of Anaesthesiology in Dhiraj hospital after approval from institutional ethical committee and written informed consent.
Aim To compare the inubating conditions for nasotracheal intubation with standard direct Macintosh laryngoscope versus BPL Video laryngoscope using cuff inflation technique in adult patients.
The objectives are : 1) To compare total duration for nasotracheal intubation with macintosh laryngoscope versus video laryngoscope by cuff inflation technique. 2) To compare hemodynamic changes during the procedure between two groups 3) To compare the need for assistance with magills forceps, external laryngeal maneuvers for nasotracheal Intubation between two groups 4) To compare total number of attempts required for successful nasotracheal intubation between two groups 5) To compare complications if any between two groups.
INCLUSION CRITERIA: 1. Patients willing to sign informed consent. 2. Male or female patients between ages of 18 to 60 years. 3. Patients belonging to American Society of Anaesthesiologists (ASA) physical status I and II. 4. Patients posted for elective surgeries requiring nasal intubation under general anaesthesia. 5. Patient having mouth opening more than 3cm 6. Patient with Malampatti grade 1 and 2
EXCLUSION CRITERIA: 1. Patients unwilling to participate in the study. 2. Patients belonging to American Society of Anaesthesiologists (ASA) physical status III and IV 3. Patients having contraindication to nasal intubation. Eg. nasal polyps,nasal bone fracture,mass in nasal cavity. 4. Patient having mouth opening less than 3cm. 5. Patient with Mallampati grade 3 and 4 Methods: 66 adult patients fulfilling the criteria including both genders, aged between 18 to 60 years will be randomly allocated using computer generated random numbers into two groups: Group V and Group M of 33 patients each. Group V (n= 33) Patients were intubated nasotracheally using non-channelled blade of BPL Video laryngoscope with cuff inflation technique Group M (n= 33 ) patients were intubated nasotracheally using Macintosh laryngoscope with cuff inflation technique The procedure will be performed by the anaesthesiologist not related to study.
Likely outcome of the study: This prospective study will help us to compare the intubating conditions for Nasotracheal intubation (NTI) with standard direct Macintosh laryngoscope versus BPL video laryngoscope using cuff inflation technique in patients undergoing surgery under general anaesthesia and will enable us to know which of the two technique is most beneficial in performing Nasotracheal Intubation by having better outcomes in hemodynamics with minimal complications.
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