CTRI

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CTRI Number

CTRI/2025/04/083976 [Registered on: 03/04/2025] Trial Registered Prospectively

Last Modified On:

02/04/2025

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Other

Public Title of Study

Percutaneous Tracheostomy in the ICU Using Grigg’s Technique A Prospective Observational Study

Scientific Title of Study

Percutaneous tracheostomy in intensive care unit with Grigg’s technique : 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	Mohammad Fuzail Abid
Designation	Junior resident
Affiliation	Jawaharlal nehru medical college, Aligarh Muslim University
Address	Department of anaesthesiology and critical care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh Aligarh UTTAR PRADESH 202002 India
Phone	8791003368
Fax
Email	fuzailabid786@gmail.com

Details of Contact Person
Scientific Query

Name	Syed Moied Ahmed
Designation	Professor
Affiliation	Jawaharlal Nehru Medical College,Aligarh Muslim University,Aligarh
Address	Department of anaesthesiology and critical care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh Aligarh UTTAR PRADESH 202002 India
Phone	9897454739
Fax
Email	sma99@rediffmail.com

Details of Contact Person
Public Query

Name	Mohammad Fuzail Abid
Designation	Junior resident
Affiliation	Jawaharlal Nehru Medical College,Aligarh Muslim University,Aligarh
Address	Department of anaesthesiology and critical care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh Aligarh UTTAR PRADESH 202002 India
Phone	8791003368
Fax
Email	fuzailabid786@gmail.com

Source of Monetary or Material Support

Department of Anaesthesiology and critical care, Jawaharlal Nehru Medical College,Aligarh Muslim University,Aligarh , India 202002

Primary Sponsor

Name	Jawaharlal Nehru Medical CollegeAligarh Muslim UniversityAligarh
Address	Jawaharlal Nehru Medical College,Aligarh Muslim University,Aligarh, India 202002
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
Dr Mohammad Fuzail Abid	Jawaharlal Nehru Medical College,Aligarh Muslim University	Department of Naaesthesiology and critical care, Jawaharlal Nehru Medical College,Aligarh Muslim University,Aligarh Aligarh UTTAR PRADESH	879103368 fuzailabid786@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee (Regd.) Jawaharlal Nehru Medical College	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: G988\|\|Other disorders of nervous system,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	Nil

Inclusion Criteria

Age From	18.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	Patients admitted for more than 3 days, in ICU All patients undergoing PCT with Grigg’s technique

ExclusionCriteria

Details

Patients have been admitted with tracheostomy
PCT was done by other technique

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
The incidence of percutaneous tracheostomy admitted in ICU undergoing mechanical ventilation.	After 3 days of admission in ICU, incidence of percutaneous tracheostomy will be noted.

Secondary Outcome

Outcome	TimePoints
The timing of PCT after mechanical ventilation Length of stay in ICU after PCT. Number of days survived after PCT Number of patients discharged from ICU after PCT. Length of hospital stay of patients after PCT. Number of patients discharged from hospital after PCT. Complication, if any. 28 day mortality of the patients after PCT.	After how many days was pct performed in the patient. I will assess the patient after 28 days & note number of days patient survived after pct, number of patients discharged from hospital, length of hospital stay. And if there were any complications.

Target Sample Size

Total Sample Size="100"
Sample Size from India="100"
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)

15/04/2025

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="0"
Months="10"
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

The thesis, titled “Percutaneous Tracheostomy in Intensive Care Unit with Grigg’s Technique: A Prospective Observational Study” investigates the incidence, timing, complications, and outcomes of percutaneous tracheostomy (PCT) performed in an ICU setting. The study focuses on critically ill patients requiring prolonged mechanical ventilation and evaluates PCT using Grigg’s technique. It aims to determine factors influencing the procedures success, including patient survival, ICU and hospital stay duration, and associated complications such as bleeding, tube displacement, and infection. By analyzing data from patients at JN Medical College and Hospital, the study seeks to contribute valuable insights into optimizing tracheostomy practices and improving patient outcomes.