NCT Number: NCT03678532
Effects of Sedation on Clinical, Gasometric and Respiratory Muscle Parameters in Critically Ill COPD Patients
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.
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Notify MeKey information
Conditions
Age range
18 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
ventilation affection
Time frame: 48 hours
changes in PaCO2 measured in mmHG
Secondary outcomes
-
effect of sedation on acid base status
Time frame: 48 hours
changes in PH
-
Effect of sedation on heart rate
Time frame: 48 hours
heart rate beat per minute changes
-
Effect of sedation on blood pressure
Time frame: 48 hours
including mean arterial blood pressure in mmHg
Sponsors and collaborators
Lead sponsor
Assiut University
Other
Registry information
Important dates
- Study start
- 2016
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Sep 19, 2018
- Registry last updated
- Sep 19, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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