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Post Operative Pulmonary ComplicationsNCT05548309

HFNC Versus Oxygen Face Mask on Postoperative Pulmonery Complications

A study testing HFNC and Oxygen face mask in people with Post Operative Pulmonary Complications, run by Alexandria University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 50 to 70 years
Conditions the study is for
Post Operative Pulmonary Complications
What is being tested?
HFNC and Oxygen face mask
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
1 siteEgypt
Study dates
30 Apr 2021to 15 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients (50-70 years).
  • Patients with American Society of Anesthesiologists (ASA) status I-III.
  • Patients with body mass index less than 35kg/m2.
  • Patients scheduled for major elective upper abdominal surgeries (gastrectomy, hepatic resection, pancreatectomy, Whipple procedures,..).
  • Upper abdominal surgery with an abdominal incision longer than 5 cm that is above or extending above the umbilicus.
  • Upper abdominal surgeries with an anticipated duration of two hours or more.
Show all 13Show fewer
  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Alexandria University,Faculty of Medicine

    Alexandria

Other trials in Egypt

About this study

Official title: The Effect of High Flow Nasal Cannula Versus Simple Face Mask Oxygen Therapy on Pulmonary Complications After Major Abdominal Surgeries

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.

Read the detailed description

After an informed written consent taken from all the patients included in this study, they were assessed thoroughly by:

  • Detailed medical and surgical history taking.
  • Complete clinical examination.
  • Routine laboratory investigations, including complete blood picture, blood urea nitrogen, serum creatinine, prothrombin (PT), activated partial thromboplastin (aPTT) times, thrombin time, fasting blood sugar.
  • Electrocardiograph (ECG) and chest x-ray.

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:

  1. Heart rate (beats/ minute).
  2. Non-invasive systolic, diastolic, and mean arterial blood pressure (mmHg).
  3. Respiratory rate (breaths/min).
  4. Peripheral oxygen saturation (%).
  5. End tidal carbon dioxide (mmHg). Epidural catheter was inserted for all patients at level T7-T9, loading dose 1-1.5 ml/segment of 0.125% bupivacaine with fentanyl 1mic/ml and was continued as an infusion intraoperatively combined with general anaesthesia with infusion rate 5ml/hour. Mechanical ventilation was initiated after tracheal intubation using volume control mode.

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:

  1. Respiratory frequency more than 25 and less than 35 breaths/min persistent for at least 1 hour.
  2. Clinical signs of respiratory distress (dyspnea, significant use of accessory muscles, or paradoxical abdominal motion).
  3. Respiratory acidosis (PH less than 7.35 units and PaCO2 more than 45 mm Hg).
  4. Moderate hypoxemia defined as PaO2/FiO2 more than 150 and less than 300.

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:

  1. Respiratory frequency 40 breaths/min.
  2. Clinical signs of respiratory distress (dyspnea, significant use of accessory muscles, or paradoxical abdominal motion).
  3. Respiratory acidosis with an arterial PH less than 7.30, and PaCO2 more than 45 mm Hg).
  4. Severe hypoxemia defined as PaO2/FiO2 less than 150. All other treatments were continued according to the standard care in ICU with patients of both groups receiving physiotherapy, upright positioning, incentive spirometry, and early mobilization.

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:
  2. The A profile associates anterior lung sliding with A lines .
  3. The A' profile is an A profile with abolished lung sliding.
  4. The B profile predominantly multiple (>2) anterior diffuse B lines indicating interstitial syndrome associates anterior lung sliding .
  5. The B' profile is a B-profile with abolished lung sliding.
  6. The C profile indicates anterior lung consolidation, regardless of size and number, thickened, irregular pleural line is an equivalent.
  7. The A/B profile is a half A profile at one lung, a half B profile at another. Furthermore, the postero lateral alveolar and/or pleural syndrome (PLAPS) was determined at PLAPS point and was scored as positive or negative. When consolidation and/or pleural effusion were detected they were scored separately; for differentiation between pneumonia and atelectasis, fever, leukocyte count, and C-reactive protein were looked for.Diaphragmatic excursion was measured (On admission day 0, day1, day 2, day3, day4, day5).

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.

Being tested
HFNC, Oxygen face mask
Keywords
HFNC, Pulmonary complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HFNCDevice

    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%.

  • Oxygen face maskDevice

    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%

Study groups in NCT05548309
Study groupRoleWhat they receive
High flow nasal cannulaActive comparatorHigh 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) .
Receives: Device: HFNC
oxygen face maskActive comparatorSimple oxygen face mask was applied to patients starting with flow rate 6L/min .
Receives: Device: Oxygen face mask

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 5 days postoperatively

Secondary outcomes (3)
  1. To detect the need for escalation of respiratory support

    The need to non invasive ventilation or intubation

    Measured: 5 days postoperatively

  2. 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

    Measured: 14 days postoperatively

  3. 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

    Measured: 21 days postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2022
  2. Study start30 Apr 2021
  3. Primary completion29 Apr 2022
  4. Study completion15 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05548309
Sponsor's protocol ID
High Flow Nasal cannula
Status last verified
Sep 2022
First submitted
12 Sep 2022
Last updated
21 Sep 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: clinical trial

Questions about this trial

What is this clinical trial studying?

A study testing HFNC and Oxygen face mask in people with Post Operative Pulmonary Complications, run by Alexandria University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 5 days postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.

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