management of post-operative respiratory failure by using niv and high velocity nasal insufflation (hvni)

Conditions: Respiratory Failure Without Hypercapnia; Respiratory Failure With Hypercapnia; Postoperative Respiratory Complication

Summary: postoperative respiratory failure (porf) remains a critical driver of morbidity, mortality, and incremental care costs in surgical populations. traditional escalation often involves invasive mechanical ventilation, which is associated with ventilator-associated pneumonia (vap), prolonged intensive care unit (icu) stays, and increased resource burden.

noninvasive ventilation (niv) and high-flow nasal cannula (hfnc) have both been shown to improve oxygen levels effectively and reduce the need for reintubation in various patient groups. however, head-to-head data in patients with obstructive or restrictive pulmonary function (porf) are scarce. this protocol employs a robust and scalable design to generate high-quality evidence, empower perioperative stakeholders, and optimize patient-centric respiratory strategies. we hypothesize that niv will reduce 72-hour reintubation rates compared to hfnc, translating into shorter icu stays and lower costs. methodology \& operational workflow * screening \& consent identify eligible patients in the post-anesthesia care unit (pacu) or icu. obtain informed consent from the patient or legal surrogate. * baseline assessment the baseline assessment includes demographics, comorbidities, and surgical data, as well as baseline arterial blood gases (abg), vital signs, and comfort scores. * randomization \& initiation allocate via a secure web-based randomization module. initiate assigned respiratory support within 30 minutes of notification. * monitoring \& data collection the patient is receiving continuous pulse oximetry and respiratory rate monitoring. abgs and fraction of inspired oxygen (fio2) at 1 hour, 6 hours, and 24 hours. comfort scores every six hours. record interface-related adverse events. - escalation criteria the patient exhibits persistent partial arterial oxygen pressure/fraction of inspired oxygen ratio (pao2/fio2) levels of less than 100, even at maximal settings. hemodynamic instability occurs due to the use of new-onset vasopressors. deterioration leading to invasive ventilation → classified as "reintubation." * weaning protocol. transition to standard oxygen therapy when the flow or pressure is minimal. * follow-up \& discharge track icu length of stay (los), hospital los, and ventilation-free days (vfd). keep a record of the 30-day survival rate and any readmissions. * statistical analysis plan primary endpoint: compare reintubation rates using a χ² test; report the risk difference and 95% confidence interval. * missing data: multiple imputation for datasets with ≤ 5% missing data; sensitivity analysis for worst-case scenarios. * interim analysis: after 50% enrollment, the data safety and monitoring board (dsmb) reviews efficacy and futility, using o'brien-fleming boundaries.

Eligibility criteria:
inclusion criteria: * age above 18 years * within 48 hours after major surgery * pao2/fio2 less than 200 * signs of respiratory distress and respiratory rate (rr) more than 25 cycles/minute exclusion criteria: * age below 18 years * pregnant ladies * orofacial trauma or burns * active gastrointestinal bleeding