To Compare Endotracheal Tube (ET) With Subglottic Suction Drainage and Standard ET in the Incidence of VAP

NCT03101202 | Completed

• 1 other identifier: IECPG-464/27.07.2016
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Ventilator Associated Pneumonia (VAP) is associated with increased hospitalisation, increased health care cost and high morbidity and mortality. The incidence of VAP increases with duration of mechanical ventilation. There is limited data especially from India on the incidence of VAP and also the role of subglottic aspiration in its prevention. The aim of this study is to determine the role of subglottic suction in the incidence of VAP.

Conditions

Ventilator-Associated Pneumonia

Outcome Measures

Primary Outcomes (2)

• Incidence of Ventilator Associated Pneumonia

  To assess the role of endotracheal tube with subglottic suction drainage on incidence of VAP as compared to standard ET tube

  28 days

• Incidence of airway colonization

  Assess the incidence of airway colonization during the period of endotracheal intubation

  28 days

Study Arms (2)

SSD Arm

EXPERIMENTAL

In the SSD arm, the patients will be intubated with an endotracheal tube with suglottic suction drainage (SSD tube)

Device: SSD tube

Standard Arm

NO INTERVENTION

In the standard arm, the patients will be intubated with the standard endotracheal tube which does not have subglottic suction.

Interventions

SSD tube DEVICE

The SSD tube allows the suction of subglottic secretions that collect above the cuff of the endotracheal tube

SSD Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age more than 18 years
• Requiring orotracheal intubation and mechanical ventilation

You may not qualify if:

• Patients intubated outside the hospital
• Patient extubated within 72 hours
• Patient already on tracheostomy
• Death occurring within 72 hours
• Pneumonia developing within 48 hours
• Patient/relatives not giving consent

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

Department of Pulmonary Medicine and Sleep Disorders, All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vijay N Nongpiur, MD

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: April 5, 2017
• Study Start: July 16, 2016
• Primary Completion: July 31, 2017
• Study Completion: August 31, 2017
• Last Updated: January 23, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)