Impact of Immediate Versus Delayed Tracheal Extubation on Length of ICU Stay of Cardiac Surgical Patients
1 other identifier
interventional
52
0 countries
N/A
Brief Summary
Ultra-fast track anaesthesia (UFTA) aims at immediate extubation of cardiac surgical patients at the end of the operation. This study compares the effect of UFTA versus continued postoperative mechanical ventilation on the ICU length of stay (LOS). Methods. Fifty two elective adult patients were randomly allocated into UFTA and conventional groups by computer-generated random numbers. Redo operations, pre-operative intubation, uncontrolled diabetes, shock/LVEF \<45%, PASP \>55mmHg, creatinine clearance \<50 ml min-1, haemodynamic instability, or those with concerns of postoperative bleeding were excluded. Pre- and intra-operative management was similar and Logistic EuroSCORE II was calculated for all. Intra-operatively, haemodynamic parameters, urine output, SPO2, arterial blood gas analysis (ABG), 5-lead ECG, operative- bypass- and cross clamp time, and opioid consumption were collected. Postoperatively, patients were compared during their ICU stay. Data were analysed by χ²/Fischer exact, unpaired student's t-test, univariate two-group repeated measures ANOVA with post hoc Dunnett's test, and Mann-Whitney U tests as appropriate. p\<0.05 was considered significant.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2011
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 20, 2015
CompletedFirst Posted
Study publicly available on registry
July 8, 2015
CompletedJuly 8, 2015
July 1, 2015
2.7 years
June 20, 2015
July 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
length of ICU stay
We measured the length of ICU stay between the two groups
post operative ICU stay (average 1 week)
Study Arms (2)
Ultra Fast-Track Anesthesia
EXPERIMENTALPatients who fulfilled the extubation criteria were extubated at the end of surgery and transferred to the ICU for follow up.
Conventional
EXPERIMENTALpatients who did not fulfill extubation criteria were left intubated and sedated and transferred to the ICU for later management
Interventions
early extubation at the end or within one hour post operatively
Eligibility Criteria
You may qualify if:
- Adult elective cardiac surgery
You may not qualify if:
- Redo operations,
- pre-operative intubation,
- uncontrolled diabetes,
- shock/LVEF \<45%,
- PASP \>55mmHg,
- creatinine clearance \<50 ml min-1,
- haemodynamic instability,
- concerns of postoperative bleeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant (associate) professor
Study Record Dates
First Submitted
June 20, 2015
First Posted
July 8, 2015
Study Start
February 1, 2011
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
July 8, 2015
Record last verified: 2015-07