An International Survey on the Use of NIV Outside the ICU

NCT07157215 | Recruiting DMC

• 1 other identifier: RC-2029/RMLIMS/2025/18.08.2025
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Non-invasive ventilation (NIV) is a way to support breathing using a mask or helmet instead of a breathing tube, and it is proven to reduce the need for intubation, save lives, shorten hospital stays, and lower costs. While NIV has long been used in intensive care units, it is now increasingly applied in emergency rooms, hospital wards, and long-term care facilities. However, global data on how it is used outside ICUs-such as which patients receive it, how well it works, and what barriers exist-is lacking. The NIV-Safety Study is a worldwide survey of doctors, nurses, and respiratory therapists to understand current practices, outcomes, and challenges of NIV use beyond the ICU. The findings aim to guide safer, more effective, and standardized use of NIV across different healthcare settings.

Conditions

Non-invasive Ventilation; Intensive Care (ICU); Safety

Keywords

NIV; SAFETY; ICU

Outcome Measures

Primary Outcomes (1)

• prevalence of non-invasive ventilation (NIV) use outside the ICU

  To assess the prevalence of non-invasive ventilation (NIV) use outside the ICU

  SIX MONTHS

Secondary Outcomes (3)

• Common conditions treated with NIV in non-ICU settings

  SIX MONTHS

• outcomes of using NIV in non-ICU settings

  six months

• Barriers and challenges faced while using NIV in non-ICU settings

  six months

Study Arms (1)

PROFESSIONAL USING NIV

physicians, nursing officers, and Respiratory therapists who treat patients with NIV

Eligibility Criteria

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

Study Population

physicians, nursing officers, and Respiratory therapists who treat patients with NIV

Sponsors & Collaborators

• Dr. Ram Manohar Lohia Hospital: lead
• Sanjay Gandhi Postgraduate Institute of Medical Sciences: collaborator
• Hamad Medical Corporation: collaborator
• Instituto Murciano de Investigación Biosanitaria (IMIB): collaborator

Study Sites (1)

Dr Ram Manohar Lohia Institute of Medical Sciences

Lucknow, Uttar Pradesh, 226012, India

RECRUITING

Related Publications (6)

• Walkey AJ, Wiener RS. Use of noninvasive ventilation in patients with acute respiratory failure, 2000-2009: a population-based study. Ann Am Thorac Soc. 2013 Feb;10(1):10-7. doi: 10.1513/AnnalsATS.201206-034OC.

  PMID: 23509327 BACKGROUND

• Carron M, Freo U, BaHammam AS, Dellweg D, Guarracino F, Cosentini R, Feltracco P, Vianello A, Ori C, Esquinas A. Complications of non-invasive ventilation techniques: a comprehensive qualitative review of randomized trials. Br J Anaesth. 2013 Jun;110(6):896-914. doi: 10.1093/bja/aet070. Epub 2013 Apr 5.

  PMID: 23562934 BACKGROUND

• Plant PK, Owen JL, Elliott MW. Early use of non-invasive ventilation for acute exacerbations of chronic obstructive pulmonary disease on general respiratory wards: a multicentre randomised controlled trial. Lancet. 2000 Jun 3;355(9219):1931-5. doi: 10.1016/s0140-6736(00)02323-0.

  PMID: 10859037 BACKGROUND

• Cabrini L, Idone C, Colombo S, Monti G, Bergonzi PC, Landoni G, Salaris D, Leggieri C, Torri G. Medical emergency team and non-invasive ventilation outside ICU for acute respiratory failure. Intensive Care Med. 2009 Feb;35(2):339-43. doi: 10.1007/s00134-008-1350-y. Epub 2008 Nov 19.

  PMID: 19018515 BACKGROUND

• Vatrella A, Fabozzi I. Non invasive ventilation away from ICU. Transl Med UniSa. 2012 Jan 18;2:64-5. Print 2012 Jan. No abstract available.

  PMID: 23905046 BACKGROUND

• Nava S. Behind a mask: tricks, pitfalls, and prejudices for noninvasive ventilation. Respir Care. 2013 Aug;58(8):1367-76. doi: 10.4187/respcare.02457.

  PMID: 23878302 BACKGROUND

Study Officials

• Mohan Gurjar, MD

  SGPGIMS

  STUDY CHAIR

• Antonio M Esquinas, MD, PhD, FCCP, FNIV, FBCV

  Instituto Murciano de Investigacion Biosanitaria,

  STUDY CHAIR

Central Study Contacts

SANJAY SINGHAL, MD

CONTACT

91-9198991155; drsanjaysinghal79@yahoo.co.in

Satheesh Munusamy, BSc

CONTACT

+91-9003949686; satheeshm.apk1985@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: sanjay

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 5, 2025
• Study Start: September 16, 2025
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 months after publication of manuscript and the data will be made accessible for up to 24 months
• Access Criteria: qualified researchers engaging in independent scientific research

Locations

IN (1)