NCT03678532

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
Last Updated

September 19, 2018

Status Verified

September 1, 2018

Enrollment Period

1.3 years

First QC Date

September 18, 2018

Last Update Submit

September 18, 2018

Conditions

Sedation in Critically Ill COPD Patients

Keywords

sedationCOPDcritically illintensive care

Outcome Measures

Primary Outcomes (1)

  • ventilation affection

    changes in PaCO2 measured in mmHG

    48 hours

Secondary Outcomes (3)

  • effect of sedation on acid base status

    48 hours

  • Effect of sedation on heart rate

    48 hours

  • Effect of sedation on blood pressure

    48 hours

Study Arms (2)

Daily interruption of sedation (control group)

EXPERIMENTAL

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)

Drug: Midazolam

No sedation

EXPERIMENTAL

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.

Drug: Midazolam

Interventions

MidazolamDRUG
Daily interruption of sedation (control group)No sedation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 25892407BACKGROUND

  • 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.

    PMID: 25528350BACKGROUND

  • 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.

    PMID: 25111642BACKGROUND

  • 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.

    PMID: 17205005BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveCritical Illness

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

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
Associate Professor of Anesthesia

Study Record Dates

First Submitted

September 18, 2018

First Posted

September 19, 2018

Study Start

July 1, 2016

Primary Completion

November 1, 2017

Study Completion

December 1, 2017

Last Updated

September 19, 2018

Record last verified: 2018-09