| CTRI Number |
CTRI/2024/02/063253 [Registered on: 28/02/2024] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Nose Breathing Tubes versus Mouth Breathing Tubes for Long Laparoscopic Abdominal Surgeries |
|
Scientific Title of Study
|
Is nasotracheal intubation a better choice over orotracheal intubation in prolonged laparoscopic abdominal surgeries? A prospective observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Uddalak Chattopadhyay |
| Designation |
Associate Professor |
| Affiliation |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi |
| Address |
4th Floor OT Complex, Department of Anesthesiology Critical care and Pain, Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9477501850 |
| Fax |
|
| Email |
uddalak@mpmmcc.tmc.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uddalak Chattopadhyay |
| Designation |
Associate Professor |
| Affiliation |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi |
| Address |
4th Floor OT Complex, Department of Anesthesiology Critical care and Pain, Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9477501850 |
| Fax |
|
| Email |
uddalak@mpmmcc.tmc.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Uddalak Chattopadhyay |
| Designation |
Associate Professor |
| Affiliation |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi |
| Address |
4th Floor OT Complex, Department of Anesthesiology Critical care and Pain, Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9477501850 |
| Fax |
|
| Email |
uddalak@mpmmcc.tmc.gov.in |
|
|
Source of Monetary or Material Support
|
| No extramural funding required. Only infrastructure of Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha cancer hospital will be used. |
|
|
Primary Sponsor
|
| Name |
Investigator initiated study - Dr Uddalak Chattopadhyay |
| Address |
4th Floor OT complex, Mahamanna Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi |
| 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 Uddalak Chattopadhyay |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre, Varanasi |
4th floor OT complex, Department of Anesthesiology, Mahamana Pandit Madan Mohan Malaviya Cancer Centre, Sunderpur, Varanasi
Varanasi
UTTAR PRADESH |
9477501850
uddalak@mpmmcc.tmc.gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MPMMCC HBCH TMC Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C269||Malignant neoplasm of ill-definedsites within the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
a. American Society of Anaesthesiologist (ASA) physical status I-II patients.
b. Aged between 18 years and above of both sexes.
c. Undergoing prolonged duration (more than 4 hours) laparoscopic surgeries under general anaesthesia.
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
a. Patient refusal and patients who are unable to give valid consent.
b. Pregnant patients.
c. Patients with ASA PS III and above.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the number of episodes of kinking or bending of the endotracheal tube in the intraoperative period. |
Throughout the intraoperative period (i.e from the time point of intubation till the time point of completion of the surgical procedure) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the proportion of patients requiring tube repositioning during surgery.
2. To evaluate the incidence of airway-related trauma in both the orotracheal & nasotracheal tube groups.
3. To compare the number of patients extubated in the operating room, recovery, & ICU between the two groups.
4. To compare the proportion of patients requiring reintubation within one hour of extubation between the orotracheal & nasotracheal tube groups.
5. To compare the end of surgery to extubation time between the two groups.
6. In cases of delayed extubation (extubation at recovery/ ICU), to compare the requirement of fentanyl & neuromuscular blocking agents in the first 12 hours after the end of surgery between the orotracheal & nasotracheal tube groups.
|
Throughout the Intraoperative (i.e from the time point of Intubation till the time point of end of the surgical procedure) & Postoperative period ( from the time point of end of the surgical procedure till the time point of extubation & at the time point of one hour after extubation). |
|
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Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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)
|
04/03/2024 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Laparoscopic surgeries performed under general anesthesia have gained significant popularity due to their minimally invasive nature and associated benefits, such as reduced postoperative pain, shorter hospital stays, and faster recovery times . However, the prolonged duration of these surgeries, particularly with the Trendelenburg position may pose challenges in terms of airway management . For example, risks of high airway pressure due to pneumoperitoneum, Trendelenburg position, and endobronchial migration of endotracheal tube may impose a threat in maintaining proper ventilation. Airway edema due to prolonged Trendelenburg position can result in difficult extubation in the form of delayed extubation or reintubation after extubation .
During general anesthesia, effective airway management is crucial to ensure adequate oxygenation and ventilation. Orotracheal and nasotracheal intubation are the two commonly used methods for securing the airway in surgical procedures. Orotracheal intubation involves inserting an endotracheal tube through the mouth, while nasotracheal intubation involves the insertion of the tube through the nose. Each method has its advantages and potential drawbacks. Orotracheal intubation provides a more direct and easier route for tube insertion . But, as per our Institutional practice experience - it is more prone to kinking & migration. Due to the relative inaccessibility of the tube position after draping, the steep Trendelenburg position, and the presence of other confounding factors creating high airway pressure (position, pneumoperitoneum), inexperienced anesthesiologists often fail to detect it. Nasotracheal intubation offers better patient comfort, is easier to secure, moves less if secured properly, and has a lesser risk of trauma to lips and tongue .
In our Institution, besides orotracheal intubation (in which we frequently encounter disadvantages like intraoperative tube kinking and endobronchial migration) we routinely perform Nasotracheal intubation also to get the believed benefit associated with it (better tube securement, less chance of tube kinking, in case of delayed extubation due to airway edema - better tolerance of endotracheal tube in the postoperative period by the patients, etc.). But there is very limited data available documenting the evidence comparing the performance and outcomes of these two methods specifically in prolonged laparoscopic abdominal surgeries.
Aim of the Study:
To compare the performance of orotracheal and nasotracheal intubation specifically in the context of prolonged laparoscopic abdominal surgeries under general anesthesia.
Objective: Primary Objective:
To compare the number of episodes of kinking or bending of the endotracheal tube in the intraoperative period. Secondary Objectives:
1. To compare the proportion of patients requiring tube repositioning during surgery.
2. To evaluate the incidence of airway-related trauma in both the orotracheal and nasotracheal tube groups.
3. To compare the number of patients extubated in the operating room, recovery, and ICU between the two groups.
4. To compare the proportion of patients requiring reintubation within one hour of extubation between the orotracheal and nasotracheal tube groups.
5. To compare the end of surgery to extubation time between the two groups.
6. In cases of delayed extubation (extubation at recovery/ ICU), to compare the requirement of fentanyl and neuromuscular blocking agents in the first 12 hours after the end of surgery between the orotracheal and nasotracheal tube groups. |