Comparison of HFNC and COT to Diaphragm Function of Post-upper Abdominal Surgery Patients

Study Overview
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Brief Summary
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This study aims to compare diaphragm thickness, air lung distribution, and several clinical and laboratory parameters on post abdominal surgery patients with conventional oxygen therapy vs high-flow nasal cannula

Detailed Description
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Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were recruited using consecutive sampling method. Subjects underwent upper-abdominal surgery were screened. Eligible and consented subjects were randomized into intervention group (high-flow nasal cannula) and control group (conventional oxygen therapy). Subject and operation characteristics were recorded prior to intervention. Clinical parameters (vital signs, Borg Score, ICON) were recorded in 10 specific times. diaphragm thickness data using abdominal ultrasonography (USG) and air lung distribution data using Electrical Impedance Tomography were collected in 7 specific times while lactate and blood gas analysis were done 4 times. 

Official Title
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Comparison of High-Flow Nasal Cannula (HFNC) and Conventional Oxygen Therapy (COT) to Diaphragm Function of Post-Upper Abdominal Surgery Patients

Conditions
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Post Abdominal Surgery

Intervention / Treatment
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* Procedure: HFNC; COT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients from 18 - 65 yrs old, American Society of Anaesthesia (ASA) status I-III, BMI < 30, patent airway, Measurement of Exercise Tolerance before Surgery (METS) Score > 4, P-POSSUM score <10%, agreed to the study Exclusion Criteria: uncooperative subjects, DNR (do not resuscitate) patients, patients with tracheostomy, pleural effusion, pneumothorax or pulmonary atelectasis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High flow nasal cannula (HFNC)<br>HFNC group: those who receive high-flow nasal cannula therapy | Procedure: HFNC; COT<br>* HFNC: high-flow nasal cannula therapy COT: conventional oxygen therapy<br>|
| Experimental: conventional oxygen therapy (COT)<br>COT group: those who receive conventional oxygen therapy group | Procedure: HFNC; COT<br>* HFNC: high-flow nasal cannula therapy COT: conventional oxygen therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diaphragm thickness | diaphragm thickness are measured sequentially by abdominal ultrasonography (mm) | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| electrical impedance tomography (EIT) data | measured data to assess lung ventilation volume and air distribution | 2 months | 
| partial 02 pressure | partial 02 pressure were collected from arterial blood gas analysis (mmHg) | 2 months | 
| partial carbondioxyde pressure | partial CO2 pressure were collected from arterial blood gas analysis (mmHg) | 2 months | 
| ICON | ICON were measured to observe hemodynamic status | 2 months | 
| lactate | lactate were measured from arterial blood | 2 months | 
| heart rate | measured from monitor (bpm) | 2 months | 
| mean arterial pressure | measured from monitor (mmHg) | 2 months | 
| respiratory rate | bpm | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HFNC, conventional oxygen, EIT, diaphragm thickness