NCT04059614

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 16, 2019

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

2 months

First QC Date

June 27, 2019

Last Update Submit

December 30, 2019

Conditions

Post Abdominal Surgery

Keywords

HFNCconventional oxygenEITdiaphragm thickness

Outcome Measures

Primary Outcomes (1)

  • diaphragm thickness

    diaphragm thickness are measured sequentially by abdominal ultrasonography (mm)

    2 months

Secondary Outcomes (8)

  • electrical impedance tomography (EIT) data

    2 months

  • partial 02 pressure

    2 months

  • partial carbondioxyde pressure

    2 months

  • ICON

    2 months

  • lactate

    2 months

  • +3 more secondary outcomes

Study Arms (2)

"High flow nasal cannula (HFNC)"

ACTIVE COMPARATOR

"HFNC group: those who receive high-flow nasal cannula therapy

Procedure: HFNC; COT

conventional oxygen therapy (COT)

EXPERIMENTAL

COT group: those who receive conventional oxygen therapy group

Procedure: HFNC; COT

Interventions

HFNC; COTPROCEDURE

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

"High flow nasal cannula (HFNC)"conventional oxygen therapy (COT)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI, Indonesia

Location

Related Publications (11)

  • 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.

    PMID: 24138710RESULT

  • 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.

    PMID: 25050494RESULT

  • 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.

    PMID: 25866645RESULT

  • 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.

    PMID: 29149868RESULT

  • 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.

    PMID: 28701227RESULT

  • 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.

    PMID: 20686280RESULT

  • 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.

    PMID: 26975890RESULT

  • 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.

    PMID: 22066065RESULT

  • 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.

    PMID: 23050520RESULT

  • 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.

    PMID: 27596161RESULT

  • 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.

    PMID: 25886857RESULT

Study Officials

  • Sidharta K Manggala, Consultant

    Indonesia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, Anesthesiologist

Study Record Dates

First Submitted

June 27, 2019

First Posted

August 16, 2019

Study Start

September 1, 2019

Primary Completion

November 1, 2019

Study Completion

December 30, 2019

Last Updated

January 2, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)