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Eighty adult patients were randomly categorized into two equal groups (forty patients each): HFNC was applied to group I, and a simple oxygen face mask was applied to group II. Postoperative pulmonary complications were assessed for five days later.
After an informed written consent taken from all the patients included in this study, they were assessed thoroughly by:
On arrival of the patient to the operative theatre peripheral intravenous cannula gauge 18 was inserted and all patients were attached to multichannel monitor (CARESCAPE™ Monitor B650) to display the following:
At the end of the surgery lung recruitment was done by closing an adjustable pressure-limiting valve at continuous positive airway pressure 30 cmH2O2 for 30 seconds.Extubation was done after patients fulfilling the criteria of extubation.
Oxygen therapy was delivered through simple face mask while transportation to ICU with flow rate 6-10L/min titrated to maintain SpO2 ≥ 94%.
Patients were randomly categorized using closed envelope technique into 2 equal groups (40 patients each as calculated by the department of biomedical informatics and medical statistics, medical research institute, Alexandria University) Group I: High flow nasal cannula (HFNC) was inserted through specific medium/large nasal prongs (Fisher & Paykel Healthcare, Auckland, New Zealand). FiO2 was continuously measured by a dedicated system (AIRVO™ 2; Fisher & Paykel Healthcare, Auckland, New Zealand) connected to the HFNC. Starting flow 35 L/min, temperature 31oc. the flow was titrated up to 60L/min with a target SpO2 of ≥94%.
Group II: Simple oxygen face mask was applied to patients starting flow rate 6L/min and titration of flow rate up to 10L/min was done to target peripheral oxygen saturation SpO2 of ≥94%.
Gradual weaning started after 6 hours when satisfactory ABG obtained, targeting SpO2 ≥ 94%.Oxygen therapy was discontinued and noninvasive positive pressure ventilation (NIPPV) was started for both groups when patients developed moderate acute hypoxemic respiratory failure at least 2 of the following criteria were met:
Endotracheal intubation was performed when the patients of both groups developed severe acute hypoxemic respiratory failure (at least 2 of the following criteria) were met:
Incidence of postoperative pulmonary complications detected in ICU by daily chest x-ray and lung US .
Chest X-ray was done on day 1, day3, day 5 and the incidence of postoperative pulmonary complications were recorded according to European Perioperative Clinical Outcome definitions (EPCO).
Lung ultrasound using (Sonosite M-Turbo® Ultrasound System) linear transducer (L38Xi 10-5 MHZ) was performed on postoperative day (POD) 0, day1, day2, day3, day4, day5, lung ultrasound views were obtained according to the Bed Side Lung Ultrasound in Emergency protocol (BLUE).
Two hands placed this way (size equivalent to the patient's hands, upper hand touching the clavicle, thumbs excluded) correspond to the location of the lung, and allow three standardized points to be defined .
1. The upper BLUE point is in the middle of the upper hand. 2. The lower BLUE point is in the middle of the lower palm. 3. The poster lateral alveolar or pleural syndromes (PLAPS) point is defined by the intersection of a horizontal line at the level of the lower BLUE point and a vertical line at the posterior axillary line.BLUE profile for each BLUE point and BLUE profile per hemi thorax will be determined as follows:
The low frequency curvilinear transducer (C60xi 5-2 MHZ) was placed in bilateral costal margins between the anterior and posterior axillary lines for longitudinal scanning. Images of diaphragmatic excursions was obtained using the liver and spleen as acoustic windows during full respiration. With normal breathing of patients in the 45° semi supination position, the maximum vertical axis between the adjacent peaks and valleys using the sinusoid in the M mode was measured as the diaphragmatic excursion movement .
Multiple respiratory cycles of at least three cycles were recorded and the average was taken. Every side measurements (right and left hemidiaphragms) was measured and calculated separately and then the average of measurements of the two sides were calculated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High flow nasal cannula | Active Comparator | High flow nasal cannula (HFNC) was inserted through nasal prongs (Fisher & Paykel Healthcare, Auckland, New Zealand) . FiO2 was continuously measured by a dedicated system (AIRVO™ 2; Fisher & Paykel Healthcare, Auckland, New Zealand) . |
|
| oxygen face mask | Active Comparator | Simple oxygen face mask was applied to patients starting with flow rate 6L/min . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HFNC | Device | High flow nasal cannula (HFNC) was inserted through specific medium/large nasal prongs . FiO2 was continuously measured by a dedicated system (AIRVO™ 2; Fisher & Paykel Healthcare, Auckland, New Zealand) connected to the HFNC. Starting flow 35 L/min, temperature 31oc. The flow was titrated up to 60L/min with a target SpO2 of ≥94%. |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the effect of HFNC and simple face mask oxygen therapy regarding postoperative pulmonary complications within five days after major elective upper abdominal surgeries. | postoperative pulmonery complications detected by lung ultrasound and chest x-ray | 5 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| To detect the need for escalation of respiratory support | The need to non invasive ventilation or intubation | 5 days postoperatively |
| Intensive care unit length of stay(days) | Discharge criteria from ICU to ward included: Toleration of mobilization, absence of vasoactive treatment, stable hemodynamic, satisfactory respiratory conditions, unnecessary for invasive monitoring, and no further active interventions planned |
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Inclusion Criteria:
Exclusion Criteria :• Patients who refuse to participate in the study.
Patients with tracheostomy
.• Patients with pre-existing pulmonary disease (pleural effusion, pneumothorax or pulmonary atelectasis).
Patients with pre-existing obstructive sleep apnea.
Patients with any nasal or facial defect that could impede use of HFNC (Nasal septal defect or any form of facial deformity).
Impaired consciousness Glasgow coma scale (GCS) less than 12.
Hemodynamic instability as systolic blood pressure less than 90 mmHg, mean arterial blood pressure less than 65 mmHg or vasopressor requirement.
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| Name | Affiliation | Role |
|---|---|---|
| Dorya fekry, MD | Alexandria University | Study Director |
| Ahmed EL-Attar, MD | Alexandria University | Study Director |
| Mohamed El Hadidy, MD | Alexandria University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria University,Faculty of Medicine | Alexandria | Egypt |
clinical trial
one month
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| Oxygen face mask | Device | Oxygen face mask was applied to patients postoperatively with starting flow 8L/min and titration of flow up to 10 L/min with target SpO2 of ≥94% |
|
| 14 days postoperatively |
| Hospital length of stay(days) | The criteria for hospital discharge included: the presence of sinus rhythm, absence of pyrexia and wound infection, normal routine blood tests, satisfactory chest X-ray, and full mobility | 21 days postoperatively |