| CTRI Number |
CTRI/2018/01/011321 [Registered on: 15/01/2018] Trial Registered Prospectively |
| Last Modified On: |
12/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Videolaryngoscopic versus Direct Laryngoscopic Paraglossal Intubation for
Cleft Lip/Palate Reconstructive Surgeries. |
|
Scientific Title of Study
|
Videolaryngoscopic versus Direct Laryngoscopic Paraglossal Intubation for
Cleft Lip/Palate Reconstructive Surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ananya Ray |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anaesthesia
PGIMER
Sector 12
Chandigarh
CHANDIGARH
160023
India |
| Phone |
9946606752 |
| Fax |
|
| Email |
ananyaray1812@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indu Mohini Sen |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anaesthesia
PGIMER
Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009532 |
| Fax |
|
| Email |
indumohini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ananya Ray |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anaesthesia
PGIMER
Sector 12
Department of Anaesthesia
PGIMER
Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009532 |
| Fax |
|
| Email |
ananyaray1812@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research
Sector 12
Chandigarh
160012 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research |
| Address |
PGIMER
Sector 12
Chandigarh |
| 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 |
| Ananya Ray |
PGIMER |
Department of Anaesthesia
4th Floor
Nehru Building
Sector 12
Chandigarh
CHANDIGARH |
9946606752
ananyaray1812@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Cleft lip
Cleft palate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Direct laryngoscope |
Intubation by paraglossal technique will be done using a direct laryngoscope. |
| Intervention |
Videolaryngoscope |
Intubation by paraglossal technique will be done using a Videolaryngoscope. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Patients with uncorrected cleft lip/palate.
Patients posted for elective cleft lip/palate reconstructive surgery. |
|
| ExclusionCriteria |
| Details |
1. Parents/guardians who do not give consent.
2. Patients who have difficulat bag and mask ventilation.
3. Patients with supraglottic mass lesions.
4. Patients with hemodynamic instability.
5. Patients with recent upper respiratory tract infections.
6. Patients with coagulation disorders. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the first pass intubation rate using the videolaryngoscope versus the direct laryngoscope in intubating by the left paraglossal approach in paediatric patients undergoing corrective surgeries for cleft lip/palate. |
To assess the first pass intubation rate using the videolaryngoscope versus the direct laryngoscope in intubating by the left paraglossal approach in paediatric patients undergoing corrective surgeries for cleft lip/palate after confirmation of successful endotracheal intubation by waveform capnography. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time taken for successful endotracheal intubation |
Time taken from removal of facemask to confirmation of correct endotracheal tube placement by waveform capnography. |
| Intubation difficulty score |
During laryngoscopy and post intubation. |
|
|
Target Sample Size
|
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" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2018 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study will be a randomized control trial
conducted in the Post Graduate Institute of Medical Education and Research,
Chandigarh between January, 2018 and October 2018. It will include paediatric
in-patients with uncorrected cleft lip/palate posted for elective reconstruction surgeries. The sample size of 80 will be block randomized into 20 groups of 4 each.It will compare the reduction in difficult laryngoscopy performed by the paraglossal technique using the Videolaryngoscope versus the direct laryngoscope. The primary outcome will be to assess the first pass intubation rate using the
videolaryngoscope versus the direct laryngoscope in intubating by the left
paraglossal approach. The secondary outcomes will be to assess the time taken for successful
endotracheal intubation and the intubation difficulty score.
|