Type II Respiratory Failure, Hypercapnic Respiratory Failure
Conditions
Keywords
Type II respiratory failure, Hypercapnia, Difficult weaning, Post-extubation, Reintubation, Non-invasive ventilation, High-flow nasal cannula
Brief summary
Acute hypercapnic respiratory failure is characterized by elevated arterial carbon dioxide levels and commonly occurs in patients with chronic respiratory diseases. Patients with type II respiratory failure who experience difficult weaning from invasive mechanical ventilation are at increased risk of post-extubation respiratory failure and reintubation. This randomized clinical trial compared high-flow nasal cannula (HFNC) with non-invasive ventilation (NIV) as respiratory support immediately after extubation in patients aged over 50 years with type II respiratory failure and difficult weaning. The primary objective was to compare reintubation rates at 72 hours and 7 days after extubation.
Interventions
Heated and humidified high-flow oxygen was delivered through a nasal cannula immediately after extubation. The device provided adjustable high-flow oxygen to achieve the predefined oxygenation and respiratory-rate targets.
Positive-pressure ventilatory support was delivered immediately after extubation through a conventional oronasal mask using spontaneous/timed (S/T) ventilation, with pressure and inspired oxygen adjusted according to predefined respiratory and gas-exchange targets.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
The study was open label because the HFNC and NIV interfaces and modes of respiratory support were readily distinguishable to participants and treating clinicians.
Intervention model description
Participants were randomly assigned in a 1:1 ratio to receive either high-flow nasal cannula (HFNC) or non-invasive ventilation (NIV) immediately after extubation.
Eligibility
Sex/Gender
ALL
Age
51 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>50 years. * Type II respiratory failure. * Receiving invasive mechanical ventilation. * Difficult weaning from invasive mechanical ventilation, defined as failure to wean after 3-7 days of weaning attempts. * Fulfillment of predefined clinical criteria for extubation. * Written informed consent.
Exclusion criteria
* Refusal to participate or absence of informed consent. * Contraindication to NIV, including hemodynamic instability, excessive respiratory secretions with poor expectoration ability, oral or facial trauma, or recent esophageal surgery. * Poor short-term prognosis, including a very high risk of death within 7 days or receipt of palliative care. * Severe failure of another organ system, including severe cardiac, neurological, renal, or hepatic failure. * Existing tracheostomy. * Loss to follow-up resulting in uncertain 28-day survival.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reintubation Rate | At 72 hours and 7 days after extubation | Number and proportion of participants requiring reinstitution of invasive mechanical ventilation after planned extubation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-Extubation Complications | From extubation through 28 days after randomization | Incidence of post-extubation complications were recorded during follow-up in the HFNC and NIV groups. |
| Treatment Failure Rate | Within 48 hours after extubation | Treatment failure was defined as escalation from HFNC to NIV or invasive mechanical ventilation in the HFNC group and requirement for invasive mechanical ventilation in the NIV group. |
| Ventilator-Free Days at Day 28 | During the first 28 days after extubation | Number of days alive and free from invasive mechanical ventilation during the first 28 days after randomization. |
| Duration of Post-Extubation Respiratory Support | Through 72 hours after extubation | Duration of respiratory support with HFNC or NIV following extubation. |
| Arterial Blood pH | At 1, 12, 24, and 48 hours after extubation | Arterial blood pH measured by arterial blood gas analysis after extubation. |
| Arterial Partial Pressure of Carbon Dioxide (PaCO2) | At 1, 12, 24, and 48 hours after extubation | PaCO2 measured by arterial blood gas analysis after extubation. |
| PaO2/FiO2 Ratio | At 1, 12, 24, and 48 hours after extubation | Ratio of arterial partial pressure of oxygen (PaO2) to fraction of inspired oxygen (FiO2), used to assess oxygenation after extubation. |
| Arterial Bicarbonate (HCO3) | At 1, 12, 24, and 48 hours after extubation | Arterial bicarbonate concentration measured as part of arterial blood gas analysis after extubation. |
Countries
Egypt
Contacts
STUDY_DIRECTORAhmed Mostafa Abdelhamid, Professor of Anesthesia
Benha University
PRINCIPAL_INVESTIGATORFatma Ahmed Abdelfattah, MD Anesthesia and intensive ca
Benha University
STUDY_CHAIRMohamed Shaker Sadek, MD chest diseases
Benha University
Outcome results
None listed