Comparison of HFNC and COT to Diaphragm Function of Post-upper Abdominal Surgery Patients
NCT ID: NCT04059614
Last Updated: 2020-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
66 participants
INTERVENTIONAL
2019-09-01
2019-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy of HFNC as an Alternative to CPAP Therapy in Surgical Patients With Suspected Moderate to Severe OSA
NCT05075668
Comparison of the Efficacy of Tidal Volume Breathing and Vital Capacity Breathing During High-flow Nasal Oxygen
NCT05571982
HFNC Versus Oxygen Face Mask on Postoperative Pulmonery Complications
NCT05548309
High-flow Nasal Oxygenation in Obese Patients During Apnea
NCT03195504
Effect of the Steep Trendelenburg Position on Respiratory Gas Heat Content
NCT02153164
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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. "
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
"High flow nasal cannula (HFNC)"
"HFNC group: those who receive high-flow nasal cannula therapy
HFNC; COT
"HFNC: high-flow nasal cannula therapy COT: conventional oxygen therapy"
conventional oxygen therapy (COT)
COT group: those who receive conventional oxygen therapy group
HFNC; COT
"HFNC: high-flow nasal cannula therapy COT: conventional oxygen therapy"
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HFNC; COT
"HFNC: high-flow nasal cannula therapy COT: conventional oxygen therapy"
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* DNR (do not resuscitate) patients,
* patients with tracheostomy, pleural effusion, pneumothorax or pulmonary atelectasis
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Indonesia University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sidharta K. Manggala
Consultant, Anesthesiologist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sidharta K Manggala, Consultant
Role: PRINCIPAL_INVESTIGATOR
Indonesia University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI, Indonesia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IndonesiaUAnes028
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.