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Prophylactic Helmet NIV versus Facemask NIV on Extubation Success in Postextubation Patients with Preexisting Cardiac Disease

Prophylactic Helmet NIV versus Facemask NIV on Extubation Success in Postextubation Patients with Preexisting Cardiac Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20240515009
Enrollment
25
Registered
2024-05-15
Start date
2022-06-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

we would like to compare the extubation success within the first 48 hours without post-extubation respiratory failure that needs immediate intubation and invasive mechanical ventilation in patients with high-risk groups due to preexisting cardiac disease (subgroup analysis) Helmet NIV

Interventions

Helmet NIV was assigned to the patient in the experimental group with continuous use for 24 hours after extubation in patients with high risk from preexisting cardiac disease (a retrospective cohort r
Prevention,Prevention

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients over the age of 18 who had been on invasive mechanical ventilation in the medicine ICU and general ward for at least 48 hours and were considered ready for extubation after a successful spontaneous breathing trial with pressure support (PSV) mode were eligible if they were at high risk of extubation failure as defined by the following criteria: older than 65 years, those with preexisting chronic cardiac or lung disease, those with an APACHE II score of more than 12, those with a BMI of more than 30 kg/m2, those with difficult or prolonged breathing for more than seven days, and those with a Charlson Comorbidity Index greater than two on the day of extubation. Preexisting cardiac disease included left ventricular dysfunction, defined by a left ventricular ejection fraction (LVEF) equal to or below 45% from any causes; a history of cardiogenic pulmonary edema; documented ischemic heart disease; or permanent atrial fibrillation. Chronic obstructive pulmonary disease, obesity hypoventilation syndrome, and restrictive lung disease were identified as preexisting chronic pulmonary diseases with subgroup analysis from high risk due to preexisting cardiac disease

Exclusion criteria

Exclusion criteria: Patients with long-term NIV use, neuromuscular disease (i.e., myopathy or myasthenia gravis), traumatic brain injury leading to intubation, accidental or self-extubation, and do-not-resuscitation after extubation, and having contraindications to NIV use

Design outcomes

Primary

MeasureTime frame
extubation success at 48 hours after extubation extubation sucess

Secondary

MeasureTime frame
NIV intolerance rate within 24 hours after extubation patient who cannot tolerate device for 24 hours,complication of NIV within 24 hours after extubation NIV complication from both device such as pressure sore, loudeness, leakage from device

Countries

Thailand

Contacts

Public ContactNapat Jirawat

Faculty of Medicine Vajira Hospital, Nawamindradhiraj University

aussie_aun@hotmail.com0893291969

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026