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CompletedNCT06888375NIVUpdated Nov 18, 2025

Humidification Practices During Hospitalized Patients on Non-Invasive Ventilation

An observational study in Acute Respiratory Disease and Non Invasive Ventilation (NIV), sponsored by Dr. Ram Manohar Lohia Hospital. Completed at 2 sites in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-18.

Sponsored by Dr. Ram Manohar Lohia Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
534
Ages
18 Years and older
Sex
All
01

Study 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. Reasons for not using humidification
  2. Reasons for choosing a specific humidification device
Read the 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.
02

Conditions studied

  • Acute Respiratory Disease
  • Non Invasive Ventilation (NIV)

Keywords

  • NIV
  • Humidification
  • Acute respiratory failure
03

In context

Lead sponsor

Dr. Ram Manohar Lohia Hospital is the lead sponsor of 9 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Physicians who refuse to give consent or not using NIV
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
534 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

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)).

    Time frame: six months

Secondary outcomes

  1. Reasons for not using humidification

    Details about the reasons for not using humidification during NIV use will also will be collected.

    Time frame: six months

  2. 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.

    Time frame: six months

07

Study locations

2 sites
  • Dr Sanjay Singhal
    Lucknow, Uttar Pradesh 226003, India
  • Dr. Ram Manohar Lohia Institute of Medical Sciences
    Lucknow, Uttar Pradesh 226010, India
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06888375
Lead sponsor
Dr. Ram Manohar Lohia Hospital
Collaborators
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Hospital General Universitario Morales Meseguer
Responsible party
Sanjay Singhal (sanjay, Dr. Ram Manohar Lohia Hospital) — Principal investigator
First posted
Mar 21, 2025
Start date
Apr 19, 2025
Primary completion
Oct 30, 2025
Completion
Oct 30, 2025
Last update
Nov 18, 2025

Study contacts

Antonio M Esquinas, MD, PhD, FCCP, FNIV
study chair · School of Non-invasive Mechanical Ventilation Hospital Morales Meseguer, Murcia, Spain

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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