| CTRI Number |
CTRI/2023/06/053679 [Registered on: 08/06/2023] Trial Registered Prospectively |
| Last Modified On: |
15/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Nasogastric tube insertion during endotracheal tube cuff deflated state. |
|
Scientific Title of Study
|
Success rate of nasogastric tube insertion in anaesthetised, intubated, adult patients: A comparison between endotracheal tube cuff inflated and deflated states |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr NAZIMUDDIN PAIK |
| Designation |
Post Graduate Trainee Anaesthesiology |
| Affiliation |
Institute of Post Graduate Medical Education and Research,Kolkata |
| Address |
Institute of Post Graduate Medical Education and Research,
Department of Anaesthesiology,
244 AJC Bose Road,Kolkata-700020
KOlkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
09434824435 |
| Fax |
|
| Email |
nazim9797@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MOHANCHANDRA MANDAL |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Institute of Post Graduate Medical Education and Research,Kolkata |
| Address |
Institute of Post Graduate Medical Education and Research,
Department of Anaesthesiology,
244 AJC Bose Road,Kolkata-700020
KOlkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
09433072820 |
| Fax |
|
| Email |
drmcmandal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MOHANCHANDRA MANDAL |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Institute of Post Graduate Medical Education and Research,Kolkata |
| Address |
Institute of Post Graduate Medical Education and Research,
Department of Anaesthesiology,
244 AJC Bose Road,Kolkata-700020
KOlkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
09433072820 |
| Fax |
|
| Email |
drmcmandal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,Institute of Post Graduate Medical Education and Research,Kolkata |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Institute of Post Graduate Medical Education and Research,244 AJC Bose Road,Kolkata-700020 |
| 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 NAZIMUDDIN PAIK |
Institute of Post Graduate Medical Education and Research and SSKM Hospital |
Main surgery operation room theatre.3rd Floor main Block. Institute of Post Graduate Medical Education and Research,
Department of Anaesthesiology,
244 AJC Bose Road,Kolkata-700020
KOlkata
Kolkata
WEST BENGAL |
9434824435
nazim9797@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R Research Oversight 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: K669||Disorder of peritoneum, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nasogastric tube insertion in a condition of the Endotracheal tube cuff deflated state |
To determine whether naso gastric tube insertion can be more successful with the endotracheal tube cuff deflated state. |
| Comparator Agent |
Nasogastric tube insertion in a condition of the Endotracheal tube cuff inflated state |
Nasogastric tube insertion usually done with endo tracheal tube cuff inflated state. Hence it will act as a comparator for the new technique i.e., nasogastric tube insertion with deflated state. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Adult above 18 years patients undergoing elective Abdominal surgeries that require intra-operative nasogastric tube insertion. |
|
| ExclusionCriteria |
| Details |
1.Anatomical/structural abnormalities such as gross deviated nasal septum, abnormality involving lips and palate.
2.Patients with oral, nasal pharyngeal , oesophageal mass.
3.Patients with significant injuries involving head neck.
4.Patients with thrombocytopenia or coagulation disorder. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients in whom successful nasogastric tube insertion will be possible in first attempt. |
Successful insertion of Nasogastric tube in first attempt. more than one attempt will be considered as failure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Time taken for Successful insertion of nasogastric tube.it is also called procedure time.
2.Adverse events during the procedure like tube kinking, coiling etc. |
in the Intra operative period after endotracheal intubation, nasogastric tube insertion will be done. |
|
|
Target Sample Size
|
Total Sample Size="244"
Sample Size from India="244"
Final Enrollment numbers achieved (Total)= "244"
Final Enrollment numbers achieved (India)="244" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2023 |
| Date of Study Completion (India) |
30/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
Modification(s)
|
Successful placement of nasogastric tube (NGT) in anaesthetised patients in operating room under General Anaesthesia appears to be challenging one compared with its insertion in awake patients owing to lack of patients cooperation in the former. In the study a comparison was done between the nasogastric tube insertion with endotracheal tube cuff inflated state and that with endotracheal cuff deflated state. Comparison was done in terms of success in the first attempt, procedure time and incidence of adverse events. In other words, the present study was conducted to compare the first-attempt success rate (primary outcome) of blind NGT insertion in neutral position between patients with ETT cuff inflated state and those with ETT deflated state; using “throat pack in-situ†as additional safety measure. Data from all 244 patients were available for analysis. Patients of both the two groups were comparable regarding their demographic parameters.
NGT insertion with ETT cuff deflated was feasible in a considerably greater number of patients compared with those where ETT cuff was kept inflated. In the current study, NGT insertion was possible in considerably more proportion of patients with the ETT cuff at deflated state compared with cuff at inflated state (approximated, 85% versus 55%, respectively). NGT placement with ETT cuff deflated state achieved about 30% more success rate.
The procedure time for NGT placement was considerably longer with ETT cuff inflated state compared to ETT cuff deflated state (38.1 versus 16.8 seconds, respectively. In the present study, quicker placement of NGT was possible with the ETT cuff at deflated state than inflated state (approximated, 17 seconds versus 38 seconds, respectively). Thus, ETT cuff deflated state yielded about 20 seconds quicker placement of NGT.
Mean arterial pressure (MAP) and heart rate (HR) were noted at different time points during the procedure: baseline, before NGT insertion, and after NGT insertion. MAP and HR were found to be comparable at all observed time-points between the inflated cuff and deflated cuff groups. In the present study, heart rate and MAP were found comparable at all points of observations between the two groups. This translates into fact that the process of tracheal cuff deflation and re-inflation for a brief period had produced a non-significant hemodynamic response.
Although higher adverse events were observed with ETT cuff inflated state, the difference between the two groups was not significant when analyzed.
Limitations In spite of every sincere effort the present study has some lacunae. This was a single-center study. Auscultation method was used for confirmation of NGT instead of more robust method such as ultrasonography, pH paper or the gold standard- the X-ray, owing to limited resource. The study was carried out in a tertiary care hospital, so hospital bias cannot be ruled out. Further research could explore additional factors across the larger and more diverse patient groups.
CONCLUSION Endotracheal cuff significantly affects the success rate of nasogastric tube insertion. The endotracheal tube cuff deflation-assisted technique improved the chances of successful nasogastric tube placement. It is also associated with reduced adverse events such as bleeding by avoiding multiple attempts. |