Trial Outcomes & Findings for Intraocular Pressure During Abdominal Aortic Aneurysm (AAA) Repair (NCT NCT00450294)

NCT ID: NCT00450294

Last Updated: 2014-03-31

Results Overview

Intraocular pressure measurements were made with a tonometer. These measurements were recorded and kept blinded from the clinicians.

• Recruitment status: COMPLETED
• Target enrollment: 10 participants
• Primary outcome timeframe: Measurements made at baseline, post induction preincision, 1 min post clamp, 5 min post clamp, 1 min pre unclamp, 1 min post unclamp, 5 min post unclamp, skin closure
• Results posted on: 2014-03-31

Participant Flow

Ten patients were recruited into the study after informed consent at the preoperative anesthetic clinic during a twelve month period.

Because this is a purely OBSERVATIONAL STUDY, there was no group assignment. All patients enrolled in the study were assigned to one group, that is, all patients had intraocular pressure measurements performed.

Participant milestones

Measure	Longitudinal Study Group This study is an OBSERVATIONAL STUDY. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair. Therefore, all ten patients had intraocular pressure measurements made at different event intervals to determine if there was a change in intraocular pressure compared to their baseline intraocular pressure that was taken before surgery. No active intervention was performed to the patients based on intraocular pressure as clinicians were blinded to the intraocular pressure values.Measurement of Central venous pressure at event intervals during abdominal aortic aneurysm repair. Data are presented as mean +/- standard error.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intraocular Pressure During Abdominal Aortic Aneurysm (AAA) Repair

Baseline characteristics by cohort

Measure	Longitudinal Group n=10 Participants This study is an observational longitudinal design. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair. Therefore, all ten patients had intraocular pressure measurements made at different event intervals to determine if there was a change in intraocular pressure compared to their baseline intraocular pressure that was taken before surgery. No active intervention was performed to the patients based on intraocular pressure as clinicians were blinded to the intraocular pressure values.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	68.5 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment Canada	10 participants n=5 Participants
Cross Clamp Duration	58 min STANDARD_DEVIATION 15.3 • n=5 Participants
Preop Right Intraocular Pressure	16.9 mm Hg STANDARD_DEVIATION 2.6 • n=5 Participants
Preop Left Intraocular Pressure	16.7 mm HG STANDARD_DEVIATION 2.7 • n=5 Participants
Body mass index	27.3 kg/m2 STANDARD_DEVIATION 3.4 • n=5 Participants
Abdominal Aortic Aneurysm Size	5.7 cm STANDARD_DEVIATION 0.5 • n=5 Participants
Cerebrovascular Accident (CVA) HAS CVA	4 participants n=5 Participants
Cerebrovascular Accident (CVA) No CVA	6 participants n=5 Participants
Diabetes mellitus HAS DM	10 participants n=5 Participants
Diabetes mellitus NO DM	0 participants n=5 Participants
Hypertension HAS HTN	10 participants n=5 Participants
Hypertension NO HTN	0 participants n=5 Participants
Hyperlipidemia HAS Hyperlipidemia	10 participants n=5 Participants
Hyperlipidemia NO Hyperlipidemia	0 participants n=5 Participants
Epidural Epidural	10 participants n=5 Participants
Epidural NO Epidural	0 participants n=5 Participants
Cumulative Crystalloid	2.84 L STANDARD_DEVIATION 0.13 • n=5 Participants
Vasopressor infusion Vasopressor Infusion	10 participants n=5 Participants
Vasopressor infusion NO vasopressor infusion	0 participants n=5 Participants
Mannitol Received Mannitol	10 participants n=5 Participants
Mannitol N) Mannitol	0 participants n=5 Participants
ASA Physical Status ASA I (healthy person)	0 participants n=5 Participants
ASA Physical Status ASA II (mild systemic disease)	0 participants n=5 Participants
ASA Physical Status AASA III (Severe systemic disease)	10 participants n=5 Participants
ASA Physical Status ASA IV (Severe systemic disease, constant threat)	0 participants n=5 Participants
ASA Physical Status ASA V (moribund person)	0 participants n=5 Participants

PRIMARY outcome

Timeframe: Measurements made at baseline, post induction preincision, 1 min post clamp, 5 min post clamp, 1 min pre unclamp, 1 min post unclamp, 5 min post unclamp, skin closure

Population: The analysis was per protocol.

Intraocular pressure measurements were made with a tonometer. These measurements were recorded and kept blinded from the clinicians.

Outcome measures

Measure	Longitudinal Group n=10 Participants This study is an OBSERVATIONAL STUDY. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair. Therefore, all ten patients had intraocular pressure measurements made at different event intervals to determine if there was a change in intraocular pressure compared to their baseline intraocular pressure that was taken before surgery. No active intervention was performed to the patients based on intraocular pressure as clinicians were blinded to the intraocular pressure values.
Right Intraocular Pressure During Various Event Intervals in Open Abdominal Aortic Aneurysm Surgery. Preoperative	16.9 mm Hg Standard Error 0.75
Right Intraocular Pressure During Various Event Intervals in Open Abdominal Aortic Aneurysm Surgery. Pre-induction	13.8 mm Hg Standard Error 0.75
Right Intraocular Pressure During Various Event Intervals in Open Abdominal Aortic Aneurysm Surgery. 1 min post clamp	14.6 mm Hg Standard Error 0.75
Right Intraocular Pressure During Various Event Intervals in Open Abdominal Aortic Aneurysm Surgery. 5 min post clamp	13.5 mm Hg Standard Error 0.75
Right Intraocular Pressure During Various Event Intervals in Open Abdominal Aortic Aneurysm Surgery. 1 min before unclamp	14.1 mm Hg Standard Error 0.75
Right Intraocular Pressure During Various Event Intervals in Open Abdominal Aortic Aneurysm Surgery. 1 min following unclamp	14.4 mm Hg Standard Error 0.75
Right Intraocular Pressure During Various Event Intervals in Open Abdominal Aortic Aneurysm Surgery. 5 min following unclamp	15 mm Hg Standard Error 0.75
Right Intraocular Pressure During Various Event Intervals in Open Abdominal Aortic Aneurysm Surgery. Skin closure	14.1 mm Hg Standard Error 0.75

PRIMARY outcome

Timeframe: Measurements made at baseline, post induction preincision, 1 min post clamp, 5 min post clamp, 1 min pre unclamp, 1 min post unclamp, 5 min post unclamp, skin closure

Intraocular pressure measurements were made with a tonometer. These measurements were recorded and kept blinded from the clinicians.

Outcome measures

Measure	Longitudinal Group n=10 Participants This study is an OBSERVATIONAL STUDY. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair. Therefore, all ten patients had intraocular pressure measurements made at different event intervals to determine if there was a change in intraocular pressure compared to their baseline intraocular pressure that was taken before surgery. No active intervention was performed to the patients based on intraocular pressure as clinicians were blinded to the intraocular pressure values.
Left Intraocular Pressure Preoperative	16.7 mm Hg Standard Error 0.57
Left Intraocular Pressure Pre-incision	15 mm Hg Standard Error 0.57
Left Intraocular Pressure 1 min post clamp	14.7 mm Hg Standard Error 0.57
Left Intraocular Pressure 5 min post clamp	13.7 mm Hg Standard Error 0.57
Left Intraocular Pressure 1 min before unclamp	14.6 mm Hg Standard Error 0.57
Left Intraocular Pressure 1 min following unclamp	15.1 mm Hg Standard Error 0.57
Left Intraocular Pressure 5 min following unclamp	15.3 mm Hg Standard Error 0.57
Left Intraocular Pressure Skin closure	14.7 mm Hg Standard Error 0.57

Adverse Events

Longitudinal Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Amit Chopra

Department of Anesthesia

Phone: 204-880-5370

Email: amitchopra1@live.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place