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Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation in Patients With Hypercapnic COPD (COPD)

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ClinicalTrials.gov Identifier: NCT03928535
Recruitment Status : Active, not recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Xiangya Hospital of Central South University

Brief Summary:
To test if high-flow conditioned oxygen therapy is noninferior to NIV for preventing postextubation respiratory failure and reintubation in patients with hypercapnic COPD, investigators plan to conduct the participants level, 1:1 randomized trial at the respiratory ICU. Participants were randomized to undergo either high-flow conditioned oxygen therapy or noninvasive mechanical ventilation after extubation. Primary outcomes were reintubation and postextubation respiratory failure within 72 hours. Secondary outcomes included length of RICU stay after extubation and mortality; partial pressure of arterial carbon dioxide.

Condition or disease Intervention/treatment Phase
High-Flow Nasal Cannula COPD Device: High-FlowNasal Cannula Device: Noninvasive Ventilation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in Patients With Hypercapnic COPD,a Randomized Controlled Trial
Actual Study Start Date : May 1, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
High-Flow Nasal Cannula
High-flow oxygen was applied immediately after extubation through specific nasal cannula.
Device: High-FlowNasal Cannula
High-flowoxygenwas applied immediately after extubation through specific nasal cannula. Flow was initially set at 10 L/min and titrated upwards in 5-L/min steps until patients experienced discomfort.Temperature was initially set to 37°C, unless reported too hot by patients, and FIO2 was regularly adjusted to the target peripheral capillary oxygen saturation (SPO2) of greater than 92%. After 24 hours, high-flow was stopped and, if necessary, patients received conventional oxygen therapy.

Noninvasive Ventilation
Noninvasive Ventilation was applied immediately after extubation.
Device: Noninvasive Ventilation
Full face mask NIV was continuously delivered immediately after extubation for a scheduled period of 24 hours after extubation. Afterward, NIV was withdrawn and oxygen was administered by Venturi mask.Both PEEP and inspiratory pressure supportwere adjusted to target a respiratory rate of 25/min and adequate gas exchange (arterial oxygen saturation [SaO2] 92%, with pH of 7.35). The FIO2 was adjusted to maintain SPO2 at less than 92%. Sedatives to increase tolerance to NIV were not allowed.




Primary Outcome Measures :
  1. Rate of reintubation [ Time Frame: Within 72 hours after extubation ]
    The proportion of patients requiring reintubation within 72 hours after extubation


Secondary Outcome Measures :
  1. RICU length of stay after extubation [ Time Frame: From date of extubation until the date of discharging from the RICU up to 28 days ]
    Length of time from extubation to discharging from the RICU

  2. Mortality [ Time Frame: Within 28 days after extubation ]
    Mortality after extubation

  3. Partial pressure of arterial carbon dioxide [ Time Frame: Within 24 hours before extubation and within 72 hours after extubation ]
    Partial pressure of arterial carbon dioxide tested at the appointed time



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of AECOPD
  • Extubation must be performed after 48 hours of invasive ventilation
  • Must be treated sequentially with HFNC or NIV after extubation
  • PaCO2≥50mmHg when extubation
  • Positive End Expiratory Pressure (PEEP) ≤8cmH2O (1cmH2O=0.098 kPa) when extubation

Exclusion Criteria:

  • Do-not-intubate
  • Tracheostomies
  • Accidental extubation
  • Self-extubation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928535


Locations
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China, Hunan
Xiangya Hospital
Changsha, Hunan, China, 410008
Sponsors and Collaborators
Xiangya Hospital of Central South University

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Responsible Party: Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT03928535     History of Changes
Other Study ID Numbers: 261358454
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hypercapnia
Signs and Symptoms, Respiratory
Signs and Symptoms