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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04059614
Other study ID # IndonesiaUAnes028
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date December 30, 2019

Study information

Verified date December 2019
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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. "


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date December 30, 2019
Est. primary completion date November 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Indonesia Cipto Mangunkusumo Hospital Jakarta Pusat DKI

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (11)

Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Böhm 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 impedanc — View Citation

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. Review. — View Citation

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 random — View Citation

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; NIVA — View Citation

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. — View Citation

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. Epub 2010 Aug 2. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Riera J, Pérez P, Cortés 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.02 — View Citation

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. — View Citation

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 — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary diaphragm thickness diaphragm thickness are measured sequentially by abdominal ultrasonography (mm) 2 months
Secondary electrical impedance tomography (EIT) data measured data to assess lung ventilation volume and air distribution 2 months
Secondary partial 02 pressure partial 02 pressure were collected from arterial blood gas analysis (mmHg) 2 months
Secondary partial carbondioxyde pressure partial CO2 pressure were collected from arterial blood gas analysis (mmHg) 2 months
Secondary ICON ICON were measured to observe hemodynamic status 2 months
Secondary lactate lactate were measured from arterial blood 2 months
Secondary heart rate measured from monitor (bpm) 2 months
Secondary mean arterial pressure measured from monitor (mmHg) 2 months
Secondary respiratory rate bpm 2 months