| CTRI Number |
CTRI/2022/01/039285 [Registered on: 10/01/2022] Trial Registered Prospectively |
| Last Modified On: |
07/06/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To assess the role of manipulating tracheal(wind pipe) tube cuff for negotiating gastric tube inside oesophagus(food pipe) |
|
Scientific Title of Study
|
A study to assess the role of endotracheal tube cuff deflation in facilitating passage of nasogastric tube in anaesthetized and intubated patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nidhi |
| Designation |
Assistant Professor |
| Affiliation |
PGIMS Rohtak |
| Address |
Room No. 10, New OT Complex, Department of Anaesthesiology,
PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8607166690 |
| Fax |
|
| Email |
drnidhi603@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nidhi |
| Designation |
Assistant Professor, Department of Anaesthesiology |
| Affiliation |
PGIMS Rohtak |
| Address |
Room No. 10, New OT Complex, Department of Anaesthesiology,
PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8607166690 |
| Fax |
|
| Email |
drnidhi603@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nidhi |
| Designation |
Assistant Professor, Department of Anaesthesiology |
| Affiliation |
PGIMS Rohtak |
| Address |
Room No. 10, New OT Complex, Department of Anaesthesiology,
PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8607166690 |
| Fax |
|
| Email |
drnidhi603@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology and critical care Pt BDSharma PGIMS UHS Rohtak |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesiology and critical care Pt BDSharma PGIMS UHS Rohtak |
| Address |
Pt. B.D.Sharma, PGIMS, UHS, Rohtak |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Nidhi |
Pt. B.D. Sharma, PGIMS , UHS,Rohtak |
Room No. 10, New OT Complex, Department of Anaesthesiology,
Rohtak
HARYANA |
8607166690
drnidhi603@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee, Pt. B.D. Sharma PGIMS, UHS Rohtak |
Approved |
|
|
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 |
Nasogastric tube insertion with endotracheal tube cuff deflation |
Nasogastric insertion will be done through selected nostril after deflating cuff of endotracheal tube. Correct placement of NGT will be confirmed by auscultation with stethoscope in epigastrium. If first attempt fails, NGT will be withdrawn, cleaned, relubricated and again inserted into same nostril with the same technique previously used.
Duration of therapy is equivalent to duration of the surgery. |
| Comparator Agent |
Nasogastric tube insertion without endotracheal cuff deflation |
Nasogastric insertion will be done through selected nostril without deflating the cuff of endotracheal tube.
Duration of therapy is equivalent to duration of the surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled for elective abdominal surgeries, aged 18-60 years with the American Society of Anaesthesiologists physical status Class 1 or 2, with (Mallampatti Grade 1 or 2) requiring nasogastric tube insertion will be included in the study |
|
| ExclusionCriteria |
| Details |
1. Refusal by the patient
2. History of Bleeding disorders
3. History of Deformities of head &neck
4. History of Base of skull fracture
5. History of Anticipated difficult airway
6. History of American Society of Anaesthesiologist Class 3or 4
7. History of radiotherapy to head and neck area
8. Patient with oesophageal varices
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of attempts and/or overall success rate for nasogastric tube insertion |
Baseline immediately after nasogastric tube insertion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Rescue manoeuvre required, Time required for nasogastric tube insertion, Complications like kinking, coiling and bleeding if any
|
Preoperatively for nasogastric tube insertion |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/01/2022 |
| Date of Study Completion (India) |
18/05/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Nasogastric tube insertion is routinely performed procedure in intubated patients inside operating room. It is a challenging job with a high failure rate using conventional technique. Failure leads to repeated insertion attempts causing injury making the situation worse. After each unsuccessful insertion, incidence of mucosal bleeding and hemodynamic complication increase which is highly undesirable. We hypothesise that deflating the endotracheal tube cuff will facilitate easy passage of nasogastric tube. Hence present study is conducted to evaluate the effect of deflating endotracheal tube cuff in facilitating nasogastric tube insertion in anaesthetized intubated patient. |