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NCT Number: NCT04059614

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

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

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Key information

Conditions

Post Abdominal Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI, Indonesia

About this study

"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. "

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HFNC; COT

Procedure

"HFNC: high-flow nasal cannula therapy COT: conventional oxygen therapy"

Primary outcomes

  1. diaphragm thickness

    Time frame: 2 months

    diaphragm thickness are measured sequentially by abdominal ultrasonography (mm)

Secondary outcomes

  1. electrical impedance tomography (EIT) data

    Time frame: 2 months

    measured data to assess lung ventilation volume and air distribution

  2. partial 02 pressure

    Time frame: 2 months

    partial 02 pressure were collected from arterial blood gas analysis (mmHg)

  3. partial carbondioxyde pressure

    Time frame: 2 months

    partial CO2 pressure were collected from arterial blood gas analysis (mmHg)

  4. ICON

    Time frame: 2 months

    ICON were measured to observe hemodynamic status

  5. lactate

    Time frame: 2 months

    lactate were measured from arterial blood

  6. heart rate

    Time frame: 2 months

    measured from monitor (bpm)

  7. mean arterial pressure

    Time frame: 2 months

    measured from monitor (mmHg)

  8. respiratory rate

    Time frame: 2 months

    bpm

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 16, 2019
Registry last updated
Jan 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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