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

Not Applicable

Completed

• Conditions: Post Abdominal Surgery
• Interventions: Procedure: HFNC; COT

• Registration Number: NCT04059614
• Lead Sponsor: Indonesia University

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. "

Study Timeline

• Study First Submitted: 2019-06-27
• Study First Submitted QC: 2019-08-15
• Study First Posted: 2019-08-16
• Study Start: 2019-09-01
• Primary Completion: 2019-11-01
• Status Verified: 2019-12
• Study Completion: 2019-12-30
• Last Update Submitted: 2019-12-30
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"High flow nasal cannula (HFNC)"	HFNC; COT	"HFNC group: those who receive high-flow nasal cannula therapy
conventional oxygen therapy (COT)	HFNC; COT	COT group: those who receive conventional oxygen therapy group

Primary Outcome Measures

Name	Time	Method
diaphragm thickness	2 months	diaphragm thickness are measured sequentially by abdominal ultrasonography (mm)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta Pusat, DKI, Indonesia