NCT06888375

Brief Summary

To date, the practice pattern of humidification during Non-Invasive Ventilation (NIV) is unknown. This study aims to assess the practice pattern of physicians regarding humidification use in hospitalized adult patients on NIV. This study will recognize the gaps between current practice and available evidence. Primary Objective: (a) Prevalence of Humidification use and their types Secondary Objective:

  1. 1.Reasons for not using humidification
  2. 2.Reasons for choosing a specific humidification device

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
534

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 21, 2025

Completed
29 days until next milestone

Study Start

First participant enrolled

April 19, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

November 18, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

March 15, 2025

Last Update Submit

November 14, 2025

Conditions

Keywords

NIVHumidificationAcute respiratory failure

Outcome Measures

Primary Outcomes (1)

  • Humidification utilization rate and their types

    Humidification utilization rate will be calculated by a total number of respondents using humidification during NIV in patients with acute respiratory failure divided by a total number of respondents involved in managing patients of acute respiratory failure on NIV. Details will also be collected regarding the type of humidification type (Heated humidifier or Heat Moisture Exchange (HME)).

    six months

Secondary Outcomes (2)

  • Reasons for not using humidification

    six months

  • Reasons for choosing a specific humidification device

    six months

Study Arms (1)

Physicians dealing with adult patients with acute respiratory failure

to assess the practice pattern of humidification use among physicians during NIV in hospitalized adult patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

web-based survey among physicians dealing with NIV in adult patients with acute respiratory failure

You may qualify if:

  • Physicians dealing with adult patients with acute respiratory failure with NIV

You may not qualify if:

  • Physicians who refuse to give consent or not using NIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dr Sanjay Singhal

Lucknow, Uttar Pradesh, 226003, India

Location

Dr. Ram Manohar Lohia Institute of Medical Sciences

Lucknow, Uttar Pradesh, 226010, India

Location

Study Officials

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

    School of Non-invasive Mechanical Ventilation Hospital Morales Meseguer, Murcia, Spain

    STUDY CHAIR

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

March 15, 2025

First Posted

March 21, 2025

Study Start

April 19, 2025

Primary Completion

October 30, 2025

Study Completion

October 30, 2025

Last Updated

November 18, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

Data obtained through this study may be provided to qualified researchers with academic interest in non-invasive ventilation. Shared Data will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites for sharing the data with the requesting party.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
six months after publication
Access Criteria
Data requests can be submitted starting six months after publication and up to 24 months. Extensions will be considered on a case-to-case basis.

Locations