HVNI vs Noninvasive Ventilation for Acute Hypercapnic Respiratory Failure

NCT04998383 | Unknown

• 1 other identifier: HVNI
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.To study the efficacy and safety of high flow nasal oxygenation using high velocity nasal insfflation technique(HiVNI) in comarison with non invasive positive pressure ventilation in COPD patients with acute hyercapnic respiratory failure
2. 2.To do selection criteria for the indication of this new physiological technique in critically ill COPD patients

Conditions

Comparison Between HVNI vs Noninvasive Ventilation for Acute Hypercapnic Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Endotracheal intubation rate

  Endotracheal intubation rate

  after 2 Hours

Study Arms (2)

HVNI

EXPERIMENTAL

High velocity nasal insufflation (Fisher \&Paykel, Auckland, New Zealan High-velocity nasal insufflation (Precision Flow;Vapotherm, Inc, Exeter, NH) (Figure 2) using a smallborenasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort

Device: HVNI

Noninvasive ventilation

EXPERIMENTAL

Respiratory assistance is provided by a NIV either Puritan Bennet 840 (Covidien, U.S.A.), EngströmCarestation (GE Healthcare, Finland) or Hamilton-G5 (Hamilton Medical, Germany), will be used for conventional non-invasive ventilation via an oronasal mask that helps patients to cope with their Breathlessness. Settings will be adjusted based on the clinical assessment of the respiratory therapist as per standard practice.

Device: HVNI

Interventions

HVNI DEVICE

High velocity nasal insufflation (Fisher \&Paykel, Auckland, New Zealan High-velocity nasal insufflation (Precision Flow;Vapotherm, Inc, Exeter, NH) (Figure 2) using a smallborenasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort.

HVNI; Noninvasive ventilation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• RR\> 25 breath/minute.
• Use of accessory muscles of respiration, paradoxical breathing, thoracoabdominal asynchrony.
• Hypoxemia evidenced by the following items:
• In patient with hypercapnic ARF:
• I.Need for oxygen therapy at FIO2\> 40% to maintain PaO2 \> 60 mmHg or SaO2\> 90% II.Blood gas analysis shows pH \<7.35 and paCO2\> 45 mmHg

You may not qualify if:

• I.Indication for emergency endotracheal intubation. II.HR \< 50 beat\\minute with decreased level of consciousness III.Persistent hemodynamic instability with
• Systolic blood pressure \<90 mmHg after infusing a bolus of crystalloid solution at a dose of 30 ml / kg.
• life-threatening arrhythmia. IV.Undrained pneumothorax or Pneumothorax with persistent air leak. V.Extensive facial trauma or burnVI.Refusal to participate. VII.Usual long-term treatment with NIV for chronic disease

Sponsors & Collaborators

• Assiut University: lead

Related Publications (11)

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• Bateman NT, Leach RM. ABC of oxygen. Acute oxygen therapy. BMJ. 1998 Sep 19;317(7161):798-801. doi: 10.1136/bmj.317.7161.798. No abstract available.

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• Rochwerg B, Brochard L, Elliott MW, Hess D, Hill NS, Nava S, Navalesi P Members Of The Steering Committee, Antonelli M, Brozek J, Conti G, Ferrer M, Guntupalli K, Jaber S, Keenan S, Mancebo J, Mehta S, Raoof S Members Of The Task Force. Official ERS/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure. Eur Respir J. 2017 Aug 31;50(2):1602426. doi: 10.1183/13993003.02426-2016. Print 2017 Aug.

  PMID: 28860265 RESULT

• Frat JP, Coudroy R, Marjanovic N, Thille AW. High-flow nasal oxygen therapy and noninvasive ventilation in the management of acute hypoxemic respiratory failure. Ann Transl Med. 2017 Jul;5(14):297. doi: 10.21037/atm.2017.06.52.

  PMID: 28828372 RESULT

• Doshi P, Whittle JS, Bublewicz M, Kearney J, Ashe T, Graham R, Salazar S, Ellis TW Jr, Maynard D, Dennis R, Tillotson A, Hill M, Granado M, Gordon N, Dunlap C, Spivey S, Miller TL. High-Velocity Nasal Insufflation in the Treatment of Respiratory Failure: A Randomized Clinical Trial. Ann Emerg Med. 2018 Jul;72(1):73-83.e5. doi: 10.1016/j.annemergmed.2017.12.006. Epub 2018 Jan 6.

  PMID: 29310868 RESULT

• Frizzola M, Miller TL, Rodriguez ME, Zhu Y, Rojas J, Hesek A, Stump A, Shaffer TH, Dysart K. High-flow nasal cannula: impact on oxygenation and ventilation in an acute lung injury model. Pediatr Pulmonol. 2011 Jan;46(1):67-74. doi: 10.1002/ppul.21326. Epub 2010 Nov 23.

  PMID: 21171186 RESULT

• Dysart K, Miller TL, Wolfson MR, Shaffer TH. Research in high flow therapy: mechanisms of action. Respir Med. 2009 Oct;103(10):1400-5. doi: 10.1016/j.rmed.2009.04.007. Epub 2009 May 21.

  PMID: 19467849 RESULT

• Spoletini G, Alotaibi M, Blasi F, Hill NS. Heated Humidified High-Flow Nasal Oxygen in Adults: Mechanisms of Action and Clinical Implications. Chest. 2015 Jul;148(1):253-261. doi: 10.1378/chest.14-2871.

  PMID: 25742321 RESULT

• Mehta S, Jay GD, Woolard RH, Hipona RA, Connolly EM, Cimini DM, Drinkwine JH, Hill NS. Randomized, prospective trial of bilevel versus continuous positive airway pressure in acute pulmonary edema. Crit Care Med. 1997 Apr;25(4):620-8. doi: 10.1097/00003246-199704000-00011.

  PMID: 9142026 RESULT

• Tan D, Walline JH, Ling B, Xu Y, Sun J, Wang B, Shan X, Wang Y, Cao P, Zhu Q, Geng P, Xu J. High-flow nasal cannula oxygen therapy versus non-invasive ventilation for chronic obstructive pulmonary disease patients after extubation: a multicenter, randomized controlled trial. Crit Care. 2020 Aug 6;24(1):489. doi: 10.1186/s13054-020-03214-9.

  PMID: 32762701 RESULT

• Patrick W, Webster K, Ludwig L, Roberts D, Wiebe P, Younes M. Noninvasive positive-pressure ventilation in acute respiratory distress without prior chronic respiratory failure. Am J Respir Crit Care Med. 1996 Mar;153(3):1005-11. doi: 10.1164/ajrccm.153.3.8630538.

  PMID: 8630538 RESULT

Study Officials

• Ahmed hamed, prof.dr

  Assiut University

  STUDY DIRECTOR

• Khalid Hussein, prof.dr

  Assiut University

  STUDY DIRECTOR

• Samiaa Hamdy, assistant professor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Nagah Gaber, MD

CONTACT

01009714349; nagahgaber89@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Patients will be randomized to either high-velocity nasal insufflation or noninvasive positive-pressure ventilation therapy and they will be enrolled if they met the inclusion criteria.

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 10, 2021
• Study Start: August 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 10, 2021

Record last verified: 2021-08