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Effects of Sedation on Clinical, Gasometric and Respiratory Muscle Parameters in Critically Ill COPD Patients

Primary Purpose

Sedation in Critically Ill COPD Patients

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Midazolam
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sedation in Critically Ill COPD Patients focused on measuring sedation, COPD, critically ill, intensive care

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Critically ill patients diagnosed as COPD, admitted to the respiratory intensive care unit (RICU) of Assiut University Hospital.

Exclusion Criteria:

Marked renal impairment (creatinine > 2mg/dl), Liver cell failure (Bilirubin> 3mg/dl), neurological disorders, age <18 or >70 and pregnancy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Daily interruption of sedation (control group)

    No sedation

    Arm Description

    Control group received daily interruption of sedation. After intubation, patients received IV infusion of midazolam. 1-2 mg / hour with increments 1-2 mg/hr gradually increasing dose till RASS reached -4 or -5. Infusion stopped at 7:00 AM. If the patient is awake no need for resuming infusion. If signs of discomfort occurred, infusion resumed at half of the prior dose, targeting conscious sedation (RASS 0: -3)

    Intervention group were managed by no-sedation strategy. Patients received bolus doses of midazolam (1-5 mg) only when needed, after atrial to control agitation by correcting the underlying cause. If the patient needed more than 3 bolus doses , IV infusion of midazolam was given by the daily interruption protocol as in the control group. No crossover was allowed between groups. Analysis was done by intension-to-treat principle.

    Outcomes

    Primary Outcome Measures

    ventilation affection
    changes in PaCO2 measured in mmHG

    Secondary Outcome Measures

    effect of sedation on acid base status
    changes in PH
    Effect of sedation on heart rate
    heart rate beat per minute changes
    Effect of sedation on blood pressure
    including mean arterial blood pressure in mmHg

    Full Information

    First Posted
    September 18, 2018
    Last Updated
    September 18, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03678532
    Brief Title
    Effects of Sedation on Clinical, Gasometric and Respiratory Muscle Parameters in Critically Ill COPD Patients
    Official Title
    Effects of Sedation on Clinical, Gasometric and Respiratory Muscle Parameters in Critically Ill COPD Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2016 (Actual)
    Primary Completion Date
    November 1, 2017 (Actual)
    Study Completion Date
    December 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

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

    5. Study Description

    Brief Summary
    the investigators conducted a randomized controlled trial in respiratory intensive care unit (RICU) of Assiut University Hospital. COPD patients admitted to RICU were included. Exclusion criteria include: Marked renal impairment, Liver cell failure, neurological disorders, age <18 or >70 and pregnancy. Patients were randomly allocated to two groups. Midazolam was used for sedation in both groups. Richmond agitation-sedation score (RASS) was used to monitor level of sedation or agitation. Control group received daily interruption of sedation. intervention group managed by no-sedation strategy. Primary outcome measure: changes in PaCO2 Secondary outcome measures include: changes in PH, heart rate, mean arterial blood pressure, respiratory rate, P0.1 and NIF.
    Detailed Description
    The researchers conducted a randomized controlled trial in respiratory intensive care unit (RICU) of Assiut University Hospital. COPD patients admitted to RICU were included. Exclusion Criteria include: Marked renal impairment (creatinine > 2mg/dl), Liver cell failure (Bilirubin> 3mg/dl), neurological disorders, age <18 or >70 and pregnancy. Patients were randomly allocated to two groups. Midazolam was used for sedation in both groups. Richmond agitation-sedation score (RASS) was used to monitor level of sedation or agitation. Control group received daily interruption of sedation. After intubation, patients received IV infusion of midazolam, gradually increasing dose till RASS reached -4 or -5. Infusion stopped at 7:00 AM. If the patient is awake no need for resuming infusion. If signs of discomfort occurred, infusion resumed at half of the prior dose, targeting conscious sedation (RASS 0: -3) Intervention group were managed by no-sedation strategy. Patients received bolus doses of midazolam only when needed, after atrial to control agitation by correcting the underlying cause. If the patient needed more than 3 bolus doses , IV infusion of midazolam was given by the daily interruption protocol as in the control group. No crossover was allowed between groups. Analysis was done by intension-to-treat principle. Follow up arterial blood gas sampling was done baseline at intubation. 1hr., 2hrs., 12hrs., 24hrs. and 48hrs. after intubation. Recording of clinical monitoring parameters (hear rate, mean arterial blood pressure, respiratory rate) was done at the same intervals. Airway occlusion pressure (P0.1) and negative inspiratory force (NIF) were measured 48 hours after intubation to test affection of respiratory muscles in both groups. Primary outcome measure: changes in PaCO2 Secondary outcome measures include: changes in PH, heart rate, mean arterial blood pressure, respiratory rate, P0.1 and NIF.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sedation in Critically Ill COPD Patients
    Keywords
    sedation, COPD, critically ill, intensive care

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    97 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Daily interruption of sedation (control group)
    Arm Type
    Experimental
    Arm Description
    Control group received daily interruption of sedation. After intubation, patients received IV infusion of midazolam. 1-2 mg / hour with increments 1-2 mg/hr gradually increasing dose till RASS reached -4 or -5. Infusion stopped at 7:00 AM. If the patient is awake no need for resuming infusion. If signs of discomfort occurred, infusion resumed at half of the prior dose, targeting conscious sedation (RASS 0: -3)
    Arm Title
    No sedation
    Arm Type
    Experimental
    Arm Description
    Intervention group were managed by no-sedation strategy. Patients received bolus doses of midazolam (1-5 mg) only when needed, after atrial to control agitation by correcting the underlying cause. If the patient needed more than 3 bolus doses , IV infusion of midazolam was given by the daily interruption protocol as in the control group. No crossover was allowed between groups. Analysis was done by intension-to-treat principle.
    Intervention Type
    Drug
    Intervention Name(s)
    Midazolam
    Primary Outcome Measure Information:
    Title
    ventilation affection
    Description
    changes in PaCO2 measured in mmHG
    Time Frame
    48 hours
    Secondary Outcome Measure Information:
    Title
    effect of sedation on acid base status
    Description
    changes in PH
    Time Frame
    48 hours
    Title
    Effect of sedation on heart rate
    Description
    heart rate beat per minute changes
    Time Frame
    48 hours
    Title
    Effect of sedation on blood pressure
    Description
    including mean arterial blood pressure in mmHg
    Time Frame
    48 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Critically ill patients diagnosed as COPD, admitted to the respiratory intensive care unit (RICU) of Assiut University Hospital. Exclusion Criteria: Marked renal impairment (creatinine > 2mg/dl), Liver cell failure (Bilirubin> 3mg/dl), neurological disorders, age <18 or >70 and pregnancy.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25892407
    Citation
    Laerkner E, Stroem T, Toft P. No-sedation during mechanical ventilation: impact on patient's consciousness, nursing workload and costs. Nurs Crit Care. 2016 Jan;21(1):28-35. doi: 10.1111/nicc.12161. Epub 2015 Apr 17.
    Results Reference
    background
    PubMed Identifier
    25528350
    Citation
    Toft P, Olsen HT, Jorgensen HK, Strom T, Nibro HL, Oxlund J, Wian KA, Ytrebo LM, Kroken BA, Chew M. Non-sedation versus sedation with a daily wake-up trial in critically ill patients receiving mechanical ventilation (NONSEDA Trial): study protocol for a randomised controlled trial. Trials. 2014 Dec 20;15:499. doi: 10.1186/1745-6215-15-499.
    Results Reference
    background
    PubMed Identifier
    25111642
    Citation
    Strom T, Toft P. Sedation and analgesia in mechanical ventilation. Semin Respir Crit Care Med. 2014 Aug;35(4):441-50. doi: 10.1055/s-0034-1382156. Epub 2014 Aug 11.
    Results Reference
    background
    PubMed Identifier
    17205005
    Citation
    Kress JP, Vinayak AG, Levitt J, Schweickert WD, Gehlbach BK, Zimmerman F, Pohlman AS, Hall JB. Daily sedative interruption in mechanically ventilated patients at risk for coronary artery disease. Crit Care Med. 2007 Feb;35(2):365-71. doi: 10.1097/01.CCM.0000254334.46406.B3.
    Results Reference
    background

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    Effects of Sedation on Clinical, Gasometric and Respiratory Muscle Parameters in Critically Ill COPD Patients

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