| CTRI Number |
CTRI/2021/06/034012 [Registered on: 04/06/2021] Trial Registered Prospectively |
| Last Modified On: |
04/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of ease of frozen Ryles tube insertion versus normal Ryles tube insertion in anesthetized patients. |
|
Scientific Title of Study
|
Comparison of ease of nasogastric intubation using a frozen nasogastric tube with nasogastric tube at room temperature in anesthetized, intubated adult patients. A prospective, randomized, open label, parallel assignment study. |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrMadhuri Dommaraju |
| Designation |
MBBS , Post graduation (MD) Anesthesiology and critical care |
| Affiliation |
Sri Venkateshwara Institute of Medical Sciences |
| Address |
Room no: 85, PG resident hostel, Department of Anaesthesiology and critical care,SVIMS, Alipiri, Tirupati,
Chittoor, Andhra pradesh ,517501, India
Room no:85PG resident hostel , SVIMS, Tirupati, Chittoor, Andhra Pradesh, 517501, INDIA
Chittoor
ANDHRA PRADESH
517501
India |
| Phone |
9652295762 |
| Fax |
|
| Email |
madhuridommaraju8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aloka Samantaray |
| Designation |
Professor and Head of Department of Anesthesiology and critical care , SVIMS |
| Affiliation |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Department of Anaesthesiology and Critical care, SVIMS quaters, SVIMS campus, SVIMS, near valmiki circle, Alipiri, Tirupati
Chittoor, Andhra Pradesh, 517501, India
Chittoor
ANDHRA PRADESH
517501
India |
| Phone |
9493547653 |
| Fax |
|
| Email |
aloksvims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aloka Samantaray |
| Designation |
Professor and Head of Department of Anesthesiology and critical care , SVIMS |
| Affiliation |
Sri Venkateswara Institute of Medical Sciences |
| Address |
SVIMS quaters, SVIMS campus, SVIMS, near valmiki circle, Alipiri, Tirupati
Chittoor, Andhra Pradesh, 517501, India
Chittoor
ANDHRA PRADESH
517501
India |
| Phone |
9493547653 |
| Fax |
|
| Email |
aloksvims@gmail.com |
|
|
Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
None |
| Address |
Not applicable |
| Type of Sponsor |
Other [Nil] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Madhuri dommaraju |
Sri Venkateswara Institute of Medical Sciences , Tirupati |
Department of Anaesthesiology , near valmiki circle, Alipiri Road Tirupati , Chittoor, Andhra Pradesh, 517501
Chittoor
ANDHRA PRADESH |
9652295762
madhuridommaraju8@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Frozen nasogastric tube |
Compare the ease of of insertion of frozen nasogastric tube and nasogastric tube at room temperature by doctors in training in intubated anesthetized adult patients. Also compare duration of insertion and complications like kinking ,knotting ,bleeding |
| Comparator Agent |
Normal nasogastric tube |
frozen nasogastric tube or room temperature nasogastric tube will be inserted in intubated anesthetized patients to see overall success rate . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I-IV aged above 18yrs
patient scheduled to undergo elective surgery under general anesthesia with endotracheal intubation and need a nasogastric tube as a usual course of management.
a patient whose trachea is intubated under chemical paralysis, needing a nasogastric tube placement |
|
| ExclusionCriteria |
| Details |
presence of nasal mass, nasal stenosis
history of corrosive poisoning
uncontrolled bleeding diathesis
recent radiotherapy to head and neck
presence of cleft lip or palate
significant deviated nasal septum
esophageal stricture and varices
base of skull fracture
patient who will not require x-ray in their usual course of management
pregnant lactating mother
patients not willing to participate in the study |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
to determine first attempt success rate of nasogastric intubation with positive whoosh test (auscultation while injecting air)
to determine the overall success rate of nasogastric intubation by radiological confirmation with plain xray (tube tip below T12) time24hrs |
At baseline and within 24hours |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of insertion of tube with selected technique and complications if any |
At baseline |
|
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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)
|
05/06/2021 |
| 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
|
Nil |
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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
|
Ever since its first description by Hunter in 1790, the Nasogastric tube(NGT) has become one of the most commonly used medical devices in routine practice. Insertion of NGT is an essential procedure for several abdominal and thoracic surgeries and is often performed by anesthesiologist in the operation room. Nasogastric intubation continues to present a challenge for those patients who are anesthetized and trachea intubated. Conventional insertion of NGT has a high failure rate of almost 55% in the first pass. This is due to the multiple apertures present in the distal portion making it susceptible to kinking, coiling and knotting.The rugged wall due to apertures may cause mucosal tear leading to bleeding. Thus many methods of insertion has come into existence, but none is earmarked as the best. Freezing the NGT have been reported to increase its rigidity, thereby facilitating the insertion with ease. The available literature suggesting a higher success rate for frozen NGT for successful placement of nasogastric tube did not convey adequately about the experience or skill level of the researcher attempting nasogastric intubation which we believe may greatly influence the first attempt success rate independent of the technique selected. Moreover, many researchers defined a successful nasogastric intubation as a positive whoosh test which may not be true. The present study is designed to determine the success rate of nasogastric intubation with a frozen nasogastric tube by trainee resident and compare the same with the conventional insertion of nasogastric tube at room temperature.
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