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CTRI Number  CTRI/2023/07/055183 [Registered on: 13/07/2023] Trial Registered Prospectively
Last Modified On: 11/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Study Of securing airway & Complications in ICU 
Scientific Title of Study   Prospective Observational Study Of Endotracheal Intubation Practice & Complications in ICU 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DRRUSHIKESH KADAM 
Designation  Junior Resident Doctor 
Affiliation  Lokmanya Tilak Municipal General Hospital and Medical College  
Address  4th floor , department of Anesthesiology,College building ,Lokmanya tilak municipal medical College,sion,Mumbai 400022

Mumbai
MAHARASHTRA
400022
India 
Phone  9404742728  
Fax    
Email  rushikadam30@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DRURVI H DESAI 
Designation  Associate Professor LTMMC AND GH 
Affiliation  Lokmanya Tilak Municipal General Hospital and Medical College  
Address  4th floor , department of Anesthesiology,College building ,Lokmanya tilak municipal medical College,sion,Mumbai 400022

Mumbai
MAHARASHTRA
400042
India 
Phone  9821598190  
Fax    
Email  urvi_desai@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  DRRUSHIKESH KADAM 
Designation  Junior Resident Doctor 
Affiliation  Lokmanya Tilak Municipal General Hospital and Medical College  
Address  4th floor , department of Anesthesiology,College building ,Lokmanya tilak municipal medical College,sion,Mumbai 400022

Mumbai
MAHARASHTRA
400022
India 
Phone  9404742728  
Fax    
Email  rushikadam30@gmail.com  
 
Source of Monetary or Material Support  
LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND HOSPITAL 
 
Primary Sponsor  
Name  LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND HOSPITAL 
Address  LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND HOSPITAL,SION WEST MUMBAI 400022 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrRushikesh kadam  Lokmanya Tilak municipal medical College   4th floor , department of Anesthesiology,College building ,Lokmanya tilak municipal medical College,sion,Mumbai 400022
Mumbai
MAHARASHTRA 
9404742728

rushikadam30@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee human research lokmanya tilak municipal medical College and general hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: J969||Respiratory failure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients requiring endotracheal intubation in preoperative ICU,trauma ICU, CVTS recovery, neurosurgery ICU  
 
ExclusionCriteria 
Details  Cardiac arrest patients  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate practice of tracheal intubation & its complications in perioperative and trauma icu  10 minutes post intubation 
 
Secondary Outcome  
Outcome  TimePoints 
1)Comparison of preoxygenation methods with nasal high flow oxygen vs NIV for decreasing
complications of desaturation
2)Correlation of patients requiring Sellick’s maneuver & aspiration if any
3)Comparison of success rate and complications using direct laryngoscopy and video
laryngoscopy
4)Correlation of inducing agents used during tracheal intubation and hypotension 
after intubation 
 
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)   21/07/2023 
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  
Being anesthesiologist, our primary responsibility is to secure airway during emergency as well as
elective situations inside as well as out of OT (1). Tracheal intubation is a crucial step in airway
management in intensive care unit, it may be associated with difficult intubation and its related
complications like hypoxia, cardiovascular collapse which could be life threatening. So, there is
always a need to prepare and have the protocols for airway management in critically ill
patients for their better safety and outcomes. Tracheal intubation in the ICU is a high-risk procedure,
Resulting in significant morbidity and mortality. Up to 40% of cases are associated with marked
hypoxemia or hypotension. The ICU patient is physiologically very different from the usual patient
who undergoes intubation in the operating room, and different intubation techniques should be
considered. The common operating room (OR) practice of sedation and neuromuscular blockade to
facilitate intubation may carry significant risk in the ICU patient with a marked oxygenation
abnormality, particularly when performed by the non-expert (2). Tracheal Intubation in intensive care
unit is affected by various factors operator, patient and environment related
factors.

Endotracheal Intubation Practice in ICU – Dr Rushikesh Kadam Page 27
Operator related factors includes level of experience and training. Patient related factors include
anatomically difficult airway and physiological factors that limit the duration of laryngoscopic attempts
such as hypoxemia and hemodynamic instability of critically ill patient. Other major concern being
inadequate fasting because of their acute presentation. 1 Hence, critically ill patient’s normal airway
becomes physiologically difficult due to rapid deterioration, urgency and decreased reserve.
Environmental factors include limited space, poor lightening, suboptimal bed characteristics and bed
space crowded with monitors that limit the proper positioning for assessment of patient airway. All

these above-mentioned factors can impair direct visualization of glottis using direct laryngoscopy
therefore making tracheal intubation difficult and increasing the rate of complications. Use of Video
laryngoscope as well as Neuromuscular blocking agents has been shown to ease intubation in
intensive care unit and emergency department.2
Preoperative Airway assessment definitely aids to identify difficult airway. This is more so in elective
inductions in OR. However, in ICU every airway can be considered as difficult airway due to the
various physiological factors associated with the critical patient. Critically ill patients could be septic
or with or without multiorgan dysfunction syndrome, with lung injury, with ionotropic
support. Therefore, inducing drugs play a very important role in maintaining the hemodynamics in
these patients during airway management, Type of inducing drugs and their doses need to be well
planned and titrated.2
Patients who are already desaturating they have very poor oxygen reserve and they do not tolerate
apneic time at all. Use of high flow nasal cannula [HFNC], NIV, nasal prongs in these patients can
prevent severe desaturation as well as increase the apnea safety time. Outcome of these patients
who received oxygen by these methods would be much better and safer for patients to decrease the
complication rates.
Availability of better suctions SALAD STRATERGY [suction assisted laryngoscopy and airway
decontamination] will also optimize better intubation techniques. (3)
Presence of more than two anesthetist is also required for facilitating a smoother intubation in the
ICU. Help is required during Sellick’s maneuver which is applied during RSI technique. Supervision
of trainee intubating critically ill patients is extremely vital for the patient’s outcome so
trainees’ supervision is mandatory.
So primarily this thesis has been proposed to know the PRACTICE of our own institute of tracheal
intubation, to learn and improvise on the methods and techniques of tracheal intubation for safer and
hemodynamically stable patients with minimal complication rates. This thesis will help in future to
make an intubation bundle for the next generations in order to prevent airway mishaps and have the
safest airway management in the ICU outside the OR.
 
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