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

U

University of Indonesia (UI)

Status

Completed

Conditions

Post Abdominal Surgery

Treatments

Procedure: HFNC; COT

Study type

Interventional

Funder types

Other

Identifiers

NCT04059614
IndonesiaUAnes028

Details and patient eligibility

About

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

Full 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. "

Enrollment

66 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

66 participants in 2 patient groups

"High flow nasal cannula (HFNC)"
Active Comparator group
Description:
"HFNC group: those who receive high-flow nasal cannula therapy
Treatment:
Procedure: HFNC; COT
conventional oxygen therapy (COT)
Experimental group
Description:
COT group: those who receive conventional oxygen therapy group
Treatment:
Procedure: HFNC; COT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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