Clinical trial NCT04059614: Comparison of HFNC and COT to Diaphragm Function of Post-upper Abdominal Surgery Patients
Official title: Comparison of High-Flow Nasal Cannula (HFNC) and Conventional Oxygen Therapy (COT) to Diaphragm Function of Post-Upper Abdominal Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Abdominal Surgery
Keywords: HFNC
conventional oxygen
EIT
diaphragm thickness
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2019-08-16
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: "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. "

Eligibility criteria: 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

Primary outcomes:
measure: diaphragm thickness
timeFrame: 2 months
Secondary outcomes:
measure: electrical impedance tomography (EIT) data
timeFrame: 2 months
measure: partial 02 pressure
timeFrame: 2 months
measure: partial carbondioxyde pressure
timeFrame: 2 months
measure: ICON
timeFrame: 2 months
measure: lactate
timeFrame: 2 months
measure: heart rate
timeFrame: 2 months
measure: mean arterial pressure
timeFrame: 2 months
measure: respiratory rate
timeFrame: 2 months
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI
Study officials:
affiliation: Indonesia University
name: Sidharta K Manggala, Consultant
role: PRINCIPAL_INVESTIGATOR
References:
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