| CTRI Number |
CTRI/2025/10/096079 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to assess if addition of a new device like nasopharyngeal airways has any effect in incidence of hypoxemia (low oxygen saturation) |
|
Scientific Title of Study
|
Comparison of the incidence of hypoxemia during sedated gastrointestinal endoscopy: Nasopharyngeal airway with nasal cannula versus nasal cannula alone : A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Varsha Balachandran |
| Designation |
Post Graduate Student |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Anaesthesiology
Armed Forces Medical College
Wanowrie
Pune
Maharashtra
Pune
MAHARASHTRA
411040
India |
| Phone |
8056260997 |
| Fax |
|
| Email |
vakrish.1412@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gunjan Singh |
| Designation |
Professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Anaesthesiology
Armed Forces Medical College
Wanowrie
Pune
Maharashtra
Pune
MAHARASHTRA
411040
India |
| Phone |
9612112136 |
| Fax |
|
| Email |
gunjanafmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gunjan Singh |
| Designation |
Professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Anaesthesiology
Armed Forces Medical College
Wanowrie
Pune
Maharashtra
Pune
MAHARASHTRA
411040
India |
| Phone |
9612112136 |
| Fax |
|
| Email |
gunjanafmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Armed Forces Medical College |
|
|
Primary Sponsor
|
| Name |
Varsha Balachandran |
| Address |
Department of Anaesthesiology
Armed Forces Medical College
Wanowrie
Pune
Maharashtra 411040 |
| Type of Sponsor |
Other [Self] |
|
|
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 Varsha Balachandran |
Command Hospital Southern Command |
Endoscopy Suite
Command Hospital
Southern Command
Pune Cantonment
Pune
MAHARASHTRA |
8056260997
vakrish.1412@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Armed Forces Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z038||Encounter for observation for other suspected diseases and conditions ruled out, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nasal cannula |
Patients receive oxygen via only nasal cannula |
| Intervention |
nasopharyngeal airway and nasal cannula |
Patients receive oxygen via nasopharyngeal airway and nasal cannula |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing gastrointestinal endoscopy
Patients accepted in ASA classification I to III |
|
| ExclusionCriteria |
| Details |
History of upper respiratory tract infection in the past two weeks
Severe chronic obstructive pulmonary disease or acute attack of asthma
Baseline oxygen saturation less than 90% when inhaling air
History of allergy to eggs, soy, albumin or sedatives
Nasal obstruction and cannot effectively inhale oxygen through the nose
Congenital anomalies affecting the anatomy of the airways
Pregnancy or lactation
Glaucoma
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will be the incidence of hypoxemia during the procedure, defined as SPO2 less than 90. Hypoxemia will be considered clinically significant if the duration of low SPO2 exceeds 1 minute. |
From induction of sedation to the end of the gastrointestinal endoscopy procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any additional measures required to manage hypoxemia, such as increasing oxygen flow or manual ventilation, will be recorded and record adverse events related to sedation or the use of the NPA |
From induction of sedation to the end of the gastrointestinal endoscopy procedure |
|
|
Target Sample Size
|
Total Sample Size="188"
Sample Size from India="188"
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)
|
30/10/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Gastrointestinal endoscopy, a widely performed diagnostic and therapeutic procedure, is often done under sedation. However, sedation can lead to respiratory depression and hypoxemia, a condition where blood oxygen levels fall below normal. Although oxygen supplementation using nasal cannulas is common practice, it may not be sufficient to prevent hypoxemia in some patients. The nasopharyngeal airway (NPA) is a device that may provide an airway for oxygenation comparable to standard nasal cannula delivery during gastrointestinal endoscopy with sedation. The present study will determine whether the addition of the NPA offers significant advantages in preventing hypoxemia by comparing outcomes between patients receiving standard oxygen delivery (standard nasal cannula) and those receiving oxygen via both a standard nasal cannula and an NPA.
|