To assess which mask is comfortable for the patient

Comparative analysis of comfort of Non-invasive ventilation (NIV) with conventional oronasal mask and bridge free oronasal mask A Randomised controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/059792

Enrollment

Registered

2023-11-14

Start date

Unknown

Completion date

Unknown

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J962- Acute and chronic respiratory failure Health Condition 2: J810- Acute pulmonary edema Health Condition 3: J958- Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified

Interventions

Intervention1: NIV WITH BRIDGE FREE ORONASAL MASK: This is a cross-over study so patients will be assessed regarding comfort using a questionnaire after using the bridge-free oronasal mask for 2 hours

Eligibility

Inclusion criteria

Inclusion criteria: All patients of either sexes, aged >18 years whether medical or post-surgical who will be fulfilling the criteria of NIV support which include 1. Acute respiratory failure type2 2. Pulmonary edema 3. Weaning in high-risk surgeries 4. Weaning after using mechanical ventilator >7 days 5. Weaning after continuous sedation >72 hrs 6. APACHE II >17.5

Exclusion criteria

Exclusion criteria: Patients who refused to give consent , hemodynamically unstable, morbidly obese, depressed consciousness, and have improper NIV mask fitting will be excluded from the study.

Design outcomes

Primary

Measure	Time frame
To determine Comfort of patient assessed by using LIKERTS scaleTimepoint: To determine Comfort of patient assessed by using LIKERTS scale after 4 hours i.e after using both masks for 2 hours each	—

Secondary

Measure	Time frame
1, Assessing Blood gas Parameters like PH, PCO2. PO2, HCO3, Na/K 2, Assesing Physiological parameters Like respiratory rate, Blood pressure, SPO2, Pulse rate 3, Assesing Ventilator parameters like leakage, fio2 4, Complications of NIV mask like facial skin erythema, nasal congestion, nasal or oral dryness, nose/sinus/ear pain, airways dryness Timepoint: The hemodynamic parameters such as RR, HR, NIBP/ABP, and SpO2 will be recorded every 30 minutes. Ventilatory parameters like fio2 and leakage hrly The ABG sample will be taken at baseline and every 2 hours during the intervention. Complications of NIV mask-like facial skin erythema, nasal congestion, nasal or oral dryness, nose/sinus/ear pain, and airway dryness will be assessed after the intervention.	—

Measure

Time frame

1, Assessing Blood gas Parameters like PH, PCO2. PO2, HCO3, Na/K 2, Assesing Physiological parameters Like respiratory rate, Blood pressure, SPO2, Pulse rate 3, Assesing Ventilator parameters like leakage, fio2 4, Complications of NIV mask like facial skin erythema, nasal congestion, nasal or oral dryness, nose/sinus/ear pain, airways dryness Timepoint: The hemodynamic parameters such as RR, HR, NIBP/ABP, and SpO2 will be recorded every 30 minutes. Ventilatory parameters like fio2 and leakage hrly The ABG sample will be taken at baseline and every 2 hours during the intervention. Complications of NIV mask-like facial skin erythema, nasal congestion, nasal or oral dryness, nose/sinus/ear pain, and airway dryness will be assessed after the intervention.

—

Countries

India

Contacts

Public ContactDR GURAVANA BHAVANI PRASAD

All India Institute of Medical Sciences Jodhpur

geethamanoj007@yahoo.co.in9414084584

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026