Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05698641 |
| Other study ID # |
FMBSUREC/01092020/Ali |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2020 |
| Est. completion date |
February 1, 2022 |
Study information
| Verified date |
January 2023 |
| Source |
Beni-Suef University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Background: In acute hypoxic respiratory failure, high-flow nasal cannula (HFNC) oxygen
treatment is gaining popularity. However, there is just a small body of research to back up
the use of HFNC in acute respiratory failure (ARF) with hypercapnia.
Aim of study: To evaluate the effectiveness of high-flow nasal cannula (HFNC) in reducing the
rate of endotracheal intubation and PCO2 level in adult patients with Acute moderate type II
respiratory failure in comparison to noninvasive positive pressure ventilation (NIPPV).
Methods : A randomized control trial that was conducted on patients with acute moderate
hypercapnic respiratory failure ARF (arterial blood gases pH 7.25-7.35, PaCO2>45 mmHg) who
were admitted to respiratory and medical critical care units from September 2020 through
February 2022 and received HFNC or NIV .The endpoint was treatment failure, which was
indicated by either invasive ventilation or mortality .
Description:
Adult patients of both sex who were admitted to ICU with acute moderate hypercapnic
respiratory failure.
Included patients were divided into two groups:
- Group A: 50 patients with acute moderate hypercapnic respiratory failure who were
treated with HFNC as ventilatory support .
- Group B: 50 patients with acute moderate hypercapnic respiratory failure who were
treated with NIV as ventilatory support .
Device used:
- For group A (HFNC) : we used either Airvo 2 Manufacturer: Fisher &Paykel Co. , Precision
flow Hi - VNI ™ (Vapotherm ) or built in HFNC mode in (e Volution ventilator ) .
- For group B (NIV) :we used Puritan Bennett™ 840 Ventilator and the used interface was
oro nasal mask of fitting size to each patient .
All patients included in the study will be subjected to the following:
1. History taking: Full history was Taken from the patients' close relatives including
personal data and a detailed medical history.
2. Full clinical assessment: All patients were subjected to full clinical examination
including general and chest examination.
3. Investigations :
1. Laboratory:
• Routine laboratory investigations including : (CBC, Na , K ,Urea ,Creatinine ,
AST,ALT, Albumin , INR,…… ( .
- ABG: on admission & as required for follow up.
- Pulmonary function test that was previously done 3 to 6 months before the
study if available
2. Radiological:
- Chest X-ray on admission & as required for follow up.
- Additional imaging according to clinical judgment as (CT chest, chest u/s )
4. Intervention:
- We included all admitted adult patients in ICU with Acute moderate Hypercapnic
patient PH: >7.25 and <7.35 and PCO2>45mmHg.
During the intervention all the included patients were treated in a randomized one to one
selection according to inclusion and exclusion criteria.with either non-invasive ventilation
(NIV), or with high-flow nasal cannula (HFNC). Both groups were treated in usual manner of
drug therapy according to their diseases etiology .
1. Group A : High-flow-oxygen group High flow nasal cannula was applied continuously through
(Airvo 2 device manufactured by Fisher & Paykel Healthcare, Auckland, New Zealand or
Precision flow Hi - VNI ™ (Vapotherm ) and built in HFNC mode in (e Volution ventilator ).
The fraction of oxygen in the gas flowing in the system was subsequently adjusted to maintain
SpO2 of 88-92%. High-flow oxygen was applied for at least 4 h per day.initial flow rate 40
liter /minute when PH 7.30-7.35 and more than 40 liter / minute when PH 7.25-7.29.
Temperature was initially set to 37°C unless reported too hot by patients at initiation.
Close monitoring and follow up for weaning based on the patient response represented by the
respiratory parameters, patient comfort and arterial blood gases .
Group B: Noninvasive-ventilation group:
Noninvasive ventilation was applied to the patient through a oronasal mask connected to an
ICU ventilator.
The pressure-support level was adjusted with the aim of obtaining tidal volume of 6 to 8 ml
per kilogram of predicted body weight , PEEP adjusted to be 5 cm of water. The FiO2 was
adjusted to maintain SpO2 of 88-92% .
The minimally required duration of noninvasive ventilation was 4 hours per day. Noninvasive
ventilation was be applied in sessions of at least 2 hour and could be resumed if the
respiratory rate was more than 30 breaths per minute or the SpO2 was less than 88%.
All ventilator settings were re-adjusted based on the results of continuous oximetry,
measurements of arterial blood gases and ventilator parameters (tidal volume, respiratory
rate, and mask leakage) as well as on the comfort of patient.
When FiO2 was lower than 30 %, tidal volume higher than 6 mL/kg of predicted body weight with
a pressure support equal or lower than 8 cm H2O and PEEP level at 5 cm H2O, NIV withdrawal
was started and conventional oxygen therapy was applied continuously through nasal cannula or
oxygen facemask.
