| CTRI Number |
CTRI/2024/12/078462 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
22/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
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A study to compare which type of technique (cuff Inflation versus magills forceps) will help in faster nasal intubation with less complication under laryngoscopy in adult patients.
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Scientific Title of Study
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A prospective study to compare the intubating conditions of cuff Inflation technique versus magills Forceps technique for nasotracheal intubation under direct Laryngoscopy in adult patients
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| Trial Acronym |
NIL |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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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
GUJARAT
391760
India |
| Phone |
9768487569 |
| Fax |
|
| Email |
dhananjay.dhasade@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Sara Mary Thomas |
| Designation |
Professor HOD |
| 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
GUJARAT
391760
India |
| Phone |
9646500158 |
| Fax |
|
| Email |
sara.cinosh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sara Mary Thomas |
| Designation |
Professor HOD |
| 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
GUJARAT
391760
India |
| Phone |
9646500158 |
| Fax |
|
| Email |
sara.cinosh@gmail.com |
|
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Source of Monetary or Material Support
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| Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre Wagodhia ,Pipariya, Vadodara, Gujarat , India Pincode- 391760 |
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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
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Countries of Recruitment
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India |
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Sites of Study
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| 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. Sumandeep vidyapeeth wagodhia
pipariya vadodara 391760
Vadodara
GUJARAT |
9768487569
dhananjay.dhasade@gmail.com |
|
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Details of Ethics Committee
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| 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
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Nasotracheal Intubation using direct laryngoscope with Cuff inflation technique. |
Patients were intubated nasotracheally using direct 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. Also Cormack-Lehane grading, the total numbers of attempts, damage to ETT cuff will be noted. |
| Comparator Agent |
Nasotracheal Intubation using direct laryngoscope with magills forceps. |
Patients were intubated nasotracheally using direct laryngoscope with magills forceps 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. Also Cormack-Lehane grading, the total numbers of attempts, damage to ETT cuff will be noted. |
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Inclusion Criteria
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| 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 equal to 3cm
6. Patient with Malampatti grade 1 , 2
|
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| ExclusionCriteria |
| Details |
1. Patients unwilling to participate in the study.
2. Patients belonging to American Society of Anaesthesiologists (ASA) physical status III & 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 & 4
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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On-site computer system |
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Blinding/Masking
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Participant and Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| This prospective and observational study will help us to compare the intubating conditions of cuff inflation technique versus magills forceps technique for nasotracheal intubation under direct laryngoscopy in adult patients undergoing surgery under general anaesthesia and will enable us to understand which technique is a superior ,hemodynamically stable and requires less duration, attempts for successful nasotracheal intubation and also have less incidence of complications |
The 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. Also other parameters will be noted like Time taken for intubation, Cormack-Lehane grading grading, the total numbers of attempts,use assistance like external laryngeal manipulation (ELM). |
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Secondary Outcome
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| Outcome |
TimePoints |
To understand which laryngoscopy with cuffinflation technique have less incidence ofcomplications like Sore throat
Post operative complications like Nasal/oralbleeding ,
Hoarseness of voice. |
patient will be assessed for complications after extubation for next 24 hours
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Target Sample Size
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Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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N/A |
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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 |
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Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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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
|
A prospective study to compare the Intubating conditions of cuff Inflation technique versus magills Forceps technique for nasotracheal Intubation under direct Laryngoscopy in adult patients AIM To compare the intubating conditions of cuff inflation technique versus magills forceps technique for nasotracheal intubation under direct laryngoscopy in adult patients
The objectives are : 1) To compare total duration for nasotracheal intubation with direct laryngoscopy by using cuff inflation technique versus magills forceps technique. 2) To compare stress response changes during the procedure between two groups 3) To compare total number of attempts required for successful nasotracheal intubation between two groups 4) 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 equal to 3cm 6. Patient with Malampatti grade 1 , 2
Exclusion Criteria : 1. Patients unwilling to participate in the study. 2. Patients belonging to American Society of Anaesthesiologists (ASA) physical status III & 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 & 4 Methods: This Randomized Prospective Observational Study will be conducted in Department of Anaesthesiology in Dhiraj hospital. After approval from institutional ethical committee the study will be conducted to compare the intubating conditions of cuff inflation technique versus magills forceps technique for nasotracheal intubation under direct laryngoscopy on 66 adult patients including both genders, aged between 18 to 60 years. Patients will be randomly allocated using computer generated random numbers into two groups: Group C and Group M of 40 patients each. Group C (n= 40) Patients will be intubated nasotracheally using direct laryngoscope with Cuff inflation technique Group M (n= 40 ) Patients will be intubated nasotracheally using direct laryngoscope with Magills forceps technique The procedure will be performed by the anaesthesiologist not related to study. All the patients will be explained clearly about the purpose and nature ofthe Study in the language they can understand. They will be included in the study only after obtaining a Written informed consent Study site: Dhiraj hospital, S.B.K.S. Medical institute and research center, Sumandeep vidyapeeth deemed to be university, piparia, vadodara,Gujarat. Study design: Randomized Prospective Observational Study
Likely Outcome of the study : This prospective and observational study will help us to compare the intubating conditions of cuff inflation technique versus magills forceps technique for nasotracheal intubation under direct laryngoscopy in adult 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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