Humidification Practices During Hospitalized Patients on Non-Invasive Ventilation (NIV)

Humidification Practices During Non-Invasive Ventilation in Hospitalized Patients: A Multinational Survey

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

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Disease; Non Invasive Ventilation (NIV)

Detailed Description

Non-invasive ventilation (NIV) provides respiratory support through a mask compared to invasive mechanical ventilation (IMV) using an endotracheal or tracheostomy tube. NIV has become a standard of care in managing acute respiratory failure, especially in acute exacerbation of chronic obstructive pulmonary disease, acute cardiogenic pulmonary edema, immunocompromised patients, and weaning from IMV. Over the past few decades, its use has increased drastically in these patients, reducing the need for IMV, morbidity, and mortality. However, various studies have reported NIV failure in 20-50% of patients owing to poor tolerance. Non-humidified inspired gases used in NIV and IMV are very dry, and their humidification can prevent their harmful effect on the respiratory system. Heat and Humidification in IMV is the standard of care worldwide, but no consensus or guidelines regarding its use during NIV. Although the upper airways are not bypassed in NIV, physiological air conditioning could be insufficient due to circuit leaks, high respiratory drive, a high fraction of inspired oxygen (FiO2), type of mask, mouth breathing, and use of dry air with ICU ventilators. Inadequate humidification in hospitalized patients with acute respiratory failure using NIV can lead to difficult intubation after NIV failure, life-threatening airway obstruction due to thick secretions, and increased airway reactivity. Based on various physiological and clinical studies, AARC clinical practice guidelines suggested humidification in patients with NIV. To date, the practice pattern of humidification during NIV is unknown.

This study aims to assess the practice pattern of physicians regarding humidification use during NIV in hospitalized adult patients. This study will recognize the gaps between current practice and available evidence.

Objective:

Primary Objective:

(a) Humidification utilization rate and their types

Secondary Objective:

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

Methodology:

1. Study design: This is a cross-sectional web-based survey among physicians who are dealing with NIV. Participation will be on an invitation basis and purely voluntary after informed consent.
2. Inclusion criteria: Physicians dealing with adult patients with acute respiratory failure
3. Exclusion criteria: Physicians who refuse to give consent
4. Study Duration: six months
5. Study setting: A pre-designed survey link will be sent to all members of the various respiratory and critical care societies. Each physician who consented to participate will receive a web-based questionnaire. Physicians who did not respond to the first email within eight weeks will receive reminders.
6. Sample Size: As per a survey by Crimi C et al.14, humidification was used in more than 50% of clinical scenarios using NIV. We calculate our sample size by using the formula N= t.p.q/ε2 where N is equal to the required sample size, t is similar to the confidence level at 95% (standard value of 1.96), p is equal to estimated prevalence (humidification use), q is equal to 1-prevalence, ε is similar to allottable error. Using the above formula in the prevalence of 50%, our sample size is 384. We will exclude responses like not using NIV, incomplete data (>10%), and working in the same unit. We added 20% to compensate for this, so our final sample size would be 462.
7. Data Analysis: Data will be collected, compiled, and analyzed using IBM-SPSS-29 software. Descriptive statistics (mean, median, and proportions) will be used to report survey questionnaire responses. The Kruskal-Walli's test will be used for non-parametric data to evaluate the variability depending on the physician's primary specialty and hospital setting.
8. Consent: The invited email will have details of the study purpose and a participant information sheet. An email will also contain a Google Form link with instructions that implied consent will be considered if they agree to participate and submit their response.

• Study Type: Observational
• Enrollment (Actual): 534

Contacts and Locations

Study Locations

• India
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226010
      • Dr. Ram Manohar Lohia Institute of Medical Sciences
    • Lucknow, Uttar Pradesh, India, 226003
      • Dr Sanjay Singhal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Physicians who refuse to give consent or not using NIV

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reasons for not using humidification	Details about the reasons for not using humidification during NIV use will also will be collected.	six months
Reasons for choosing a specific humidification device	Depending upon their preference of humidification devices (Heated humidifier or HME), details will also be collected for the reasons about their preference.	six months

Collaborators and Investigators

• Sponsor: Dr. Ram Manohar Lohia Hospital
• Collaborators: Hospital General Universitario Morales Meseguer; Sanjay Gandhi Postgraduate Institute of Medical Sciences
• Investigators: Study Chair: Antonio M Esquinas, MD, PhD, FCCP, FNIV, School of Non-invasive Mechanical Ventilation Hospital Morales Meseguer, Murcia, Spain

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2025
• Primary Completion (Actual): October 30, 2025
• Study Completion (Actual): October 30, 2025

Study Registration Dates

• First Submitted: March 15, 2025
• First Submitted That Met QC Criteria: March 15, 2025
• First Posted (Actual): March 21, 2025

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: NIV; Acute respiratory failure; Humidification
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders
• Other Study ID Numbers: IEC No. 244/24; RC1779 (Other Identifier: RESEARCH CELL, Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow (India))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: six months after publication
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No