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Post Abdominal SurgeryNCT04059614

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

A study testing HFNC; COT in people with Post Abdominal Surgery, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Post Abdominal Surgery
What is being tested?
HFNC; COT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteIndonesia
Study dates
1 Sep 2019to 30 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • uncooperative subjects,
  • DNR (do not resuscitate) patients,
  • patients with tracheostomy, pleural effusion, pneumothorax or pulmonary atelectasis

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Cipto Mangunkusumo Hospital

    Jakarta Pusat, DKI

Other trials in Indonesia

About this study

Official title: Comparison of High-Flow Nasal Cannula (HFNC) and Conventional Oxygen Therapy (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

Read the 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. "

Being tested
HFNC; COT
Keywords
HFNC, conventional oxygen, EIT, diaphragm thickness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HFNC; COTProcedure or surgery

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

Study groups in NCT04059614
Study groupRoleWhat they receive
"High flow nasal cannula (HFNC)"Active comparator"HFNC group: those who receive high-flow nasal cannula therapy
Receives: Procedure: HFNC; COT
conventional oxygen therapy (COT)ExperimentalCOT group: those who receive conventional oxygen therapy group
Receives: Procedure: HFNC; COT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. diaphragm thickness

    diaphragm thickness are measured sequentially by abdominal ultrasonography (mm)

    Measured: 2 months

Secondary outcomes (8)

  1. electrical impedance tomography (EIT) data

    measured data to assess lung ventilation volume and air distribution

    Measured: 2 months

  2. partial 02 pressure

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

    Measured: 2 months

  3. partial carbondioxyde pressure

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

    Measured: 2 months

  4. ICON

    ICON were measured to observe hemodynamic status

    Measured: 2 months

  5. lactate

    lactate were measured from arterial blood

    Measured: 2 months

  6. heart rate

    measured from monitor (bpm)

    Measured: 2 months

  7. mean arterial pressure

    measured from monitor (mmHg)

    Measured: 2 months

  8. respiratory rate

    bpm

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2019
  2. Study start1 Sep 2019
  3. Primary completion1 Nov 2019
  4. Study completion30 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04059614
Sponsor's protocol ID
IndonesiaUAnes028
Status last verified
Dec 2019
First submitted
27 Jun 2019
Last updated
2 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Futier E, Paugam-Burtz C, Constantin JM, Pereira B, Jaber S. The OPERA trial - comparison of early nasal high flow oxygen therapy with standard care for prevention of postoperative hypoxemia after abdominal surgery: study protocol for a multicenter randomized controlled trial. Trials. 2013 Oct 18;14:341. doi: 10.1186/1745-6215-14-341.

    PubMed 24138710

  • Futier E, Marret E, Jaber S. Perioperative positive pressure ventilation: an integrated approach to improve pulmonary care. Anesthesiology. 2014 Aug;121(2):400-8. doi: 10.1097/ALN.0000000000000335. No abstract available.

    PubMed 25050494

  • Nishimura M. High-flow nasal cannula oxygen therapy in adults. J Intensive Care. 2015 Mar 31;3(1):15. doi: 10.1186/s40560-015-0084-5. eCollection 2015.

    PubMed 25866645

  • Ni YN, Luo J, Yu H, Liu D, Liang BM, Yao R, Liang ZA. Can high-flow nasal cannula reduce the rate of reintubation in adult patients after extubation? A meta-analysis. BMC Pulm Med. 2017 Nov 17;17(1):142. doi: 10.1186/s12890-017-0491-6.

    PubMed 29149868

  • Zhao H, Wang H, Sun F, Lyu S, An Y. High-flow nasal cannula oxygen therapy is superior to conventional oxygen therapy but not to noninvasive mechanical ventilation on intubation rate: a systematic review and meta-analysis. Crit Care. 2017 Jul 12;21(1):184. doi: 10.1186/s13054-017-1760-8.

    PubMed 28701227

  • Narita M, Tanizawa K, Chin K, Ikai I, Handa T, Oga T, Niimi A, Tsuboi T, Mishima M, Uemoto S, Hatano E. Noninvasive ventilation improves the outcome of pulmonary complications after liver resection. Intern Med. 2010;49(15):1501-7. doi: 10.2169/internalmedicine.49.3375. Epub 2010 Aug 2.

    PubMed 20686280

  • Jaber S, Lescot T, Futier E, Paugam-Burtz C, Seguin P, Ferrandiere M, Lasocki S, Mimoz O, Hengy B, Sannini A, Pottecher J, Abback PS, Riu B, Belafia F, Constantin JM, Masseret E, Beaussier M, Verzilli D, De Jong A, Chanques G, Brochard L, Molinari N; NIVAS Study Group. Effect of Noninvasive Ventilation on Tracheal Reintubation Among Patients With Hypoxemic Respiratory Failure Following Abdominal Surgery: A Randomized Clinical Trial. JAMA. 2016 Apr 5;315(13):1345-53. doi: 10.1001/jama.2016.2706.

    PubMed 26975890

  • Lee BC, Kyoung KH, Kim YH, Hong SK. Non-invasive ventilation for surgical patients with acute respiratory failure. J Korean Surg Soc. 2011 Jun;80(6):390-6. doi: 10.4174/jkss.2011.80.6.390. Epub 2011 Jun 9.

    PubMed 22066065

  • Riera J, Perez P, Cortes J, Roca O, Masclans JR, Rello J. Effect of high-flow nasal cannula and body position on end-expiratory lung volume: a cohort study using electrical impedance tomography. Respir Care. 2013 Apr;58(4):589-96. doi: 10.4187/respcare.02086.

    PubMed 23050520

  • Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5.

    PubMed 27596161

  • Umbrello M, Formenti P, Longhi D, Galimberti A, Piva I, Pezzi A, Mistraletti G, Marini JJ, Iapichino G. Diaphragm ultrasound as indicator of respiratory effort in critically ill patients undergoing assisted mechanical ventilation: a pilot clinical study. Crit Care. 2015 Apr 13;19(1):161. doi: 10.1186/s13054-015-0894-9.

    PubMed 25886857

Questions about this trial

What is this clinical trial studying?

A study testing HFNC; COT in people with Post Abdominal Surgery, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

diaphragm thickness (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04059614, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020; AzTrials last refreshed its copy on 6 Nov 2026.

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