Postoperative DeliriumiPODNCT02904928
Incidence and Perioperative Factors Associated With Postoperative Delirium
An observational study of Postoperative Delirium, run by Makerere University at 1 site in Uganda.
Trial summary
With the increasing number of advanced surgical operations being done annually, including the elderly, the risk of developing postoperative delirium is potentially high. Postoperative delirium is associated with longer hospital stay, poorer functional outcome, cognitive decline and an elevated morbidity and mortality… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Delirium
- How many people
- 437 participants
- Where
- 1 siteUganda
- Study dates
- Aug 2015to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients with surgical disease admitted on the surgical wards in Mulago National Referral Hospital scheduled for surgery during the study period who met the eligibility criteria
Who may be able to join
- All adult patients above 18 years who have consented to participate in the study and are fully conscious by the Glasgow coma scale
Who cannot join
- Patients with psychiatric disease confirmed by medical documents, as these were unable to provide informed consent
- Patients undergoing neuro surgery and open heart surgery, as these patients were expected to remain intubated postoperatively, precluding cognitive assessments.
- Patients scheduled for emergency surgery. Sample size Estimation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence and Perioperative Factors Associated With Postoperative Delirium Among Surgical Patients in Mulago National Referral Hospital
With the increasing number of advanced surgical operations being done annually, including the elderly, the risk of developing postoperative delirium is potentially high. Postoperative delirium is associated with longer hospital stay, poorer functional outcome, cognitive decline and an elevated morbidity and mortality, in addition to an increased cost of health care. However, most of the studies on postoperative delirium have been done in high income countries, leaving a paucity of literature on the incidence and associated factors of postoperative delirium in Africa and hence a need to do this study.
Read the detailed description
The paucity of literature in the low income setting as regards to the complication of post operative delirium has led to under recognition and under diagnosis of this problem.The lack of diagnostic tools, such as the CAM, has contributed to low rates of diagnosis and index of suspicion among clinicians.
Objectives were To determine the incidence and perioperative factors associated with postoperative delirium in adult patients undergoing elective surgery in Mulago National Referral Hospital (MNRH) Procedure Patient recruitment Patients were stratified by ward and then systematic sampling was used with a sampling interval of 3. On each day of recruitment, the first 3 patients on the theatre list on a particular ward were selected by writing numbers 1 to 3 on pieces of paper and randomly selecting one; the number selected would be the first to be enrolled, succeeded by every 3rd patient on the theatre list for that day. Written informed consent was obtained preoperatively from each study patient.
Preoperative assessment Trained research assistants conducted the preoperative interviews with a questionnaire within 12 hours before surgery. Patient demographics, pain scores, Glasgow coma scores, smoking history, alcohol consumption, anaesthetic history, American Society of Anaesthesiologists (ASA), Class as recorded on the anaesthetic chart, vitals and laboratory results of complete blood count, renal and liver functional tests available were recorded.
Delirium assessment To determine the presence of delirium, research assistants conducted structured interviews preoperatively and on the first three postoperative days between hours of 9am and 12 pm, using the Confusion Assessment Method (CAM). Based on a structured interview, the CAM algorithm included four clinical criteria: acute onset and fluctuating course, inattention, disorganized thinking, and altered level of consciousness. To define delirium, both the first and second criteria had to have been present, plus either criterion three or four. The research assistants were trained in CAM use.
To ensure consistency in the evaluation, each patient was evaluated by the same research assistant for all three interviews. All cases of incident delirium were validated by a second investigator. The investigators focused on delirium measurement on the first 3 days postoperatively, aiming to avoid loss to follow up as the majority of postoperative patients in our setting get discharged on the third postoperative day.
Associated factors Risk factors identified during the preoperative interviews included age, history of smoking and alcohol use, preoperative pain scores, medications, and electrolytes. Other factors including type of surgery, ASA classification, duration of anaesthesia, Intraoperative blood loss as recorded on the anaesthetic charts. Blood loss was estimated using the common method of adding up volumes of blood absorbed in the commonly used absorptive materials including the gauze pieces, sponges and the mops. Suction canisters measured pre and post operatively and calculated minus the irrigation used in the case. Then the total estimated intraoperative blood loss was charted on the anaesthetic chart, intraoperative medications were obtained from the anaesthetic chart.
- Conditions
- Postoperative Delirium
- Medical subject headings
- Emergence Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postoperative delirium
the CAM assessment tool was administered preoperative and then delirium assessed postoperatively at the times given above using a CAM diagnostic tool administered by research assistant.when the patient was CAM positive at any time they were discontinued from the study
Measured: 72 hours
Secondary outcomes (1)
perioperative factors associated with postoperative delirium
using a pretested questionnaire, perioperative factors were assessed
Measured: up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startAug 2015
- Primary completionFeb 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 437 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JOSHUA SEMPIIRA, MBCHB, Principal investigator, MAKERERE UNIVERSITY DEPARTMENT OF ANAETHESIADICKENS H AKENA, PHD, Study director, MAKERERE UNIVERSITY DEPARTMENT OF PSYCHIATRYEMMANUEL T AYEBALE, MMED, Study director, MAKERERE UNIVERSITY DEPARTMENT OF ANAESTHESIAAGNES WABULE, MMED, Study chair, MAKERERE UNIVERSITY DEPARTMENT OF ANAESTHESIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904928
- Sponsor's protocol ID
- 2013/HDO7/611
- Acronym
- iPOD
- Status last verified
- May 2015
- First submitted
- 4 Aug 2016
- Last updated
- 19 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Perioperative Factors Associated With Postoperative Delirium Among Surgical Patients in Mulago National Referral Hospital
- ClinicalTrials.gov ID
- NCT02904928
- Acronym / sponsor ID
- iPOD / 2013/HDO7/611
- Conditions
- Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 437 participants (actual)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With the increasing number of advanced surgical operations being done annually, including the elderly, the risk of developing postoperative delirium is potentially high. Postoperative delirium is associated with longer hospital stay, poorer functional outcome, cognitive decline and an elevated morbidity and mortality, in addition to an increased cost of health care. However, most of the studies on postoperative delirium have been done in high income countries, leaving a paucity of literature on the incidence and associated factors of postoperative delirium in Africa and hence a need to do this study.
Detailed description
The paucity of literature in the low income setting as regards to the complication of post operative delirium has led to under recognition and under diagnosis of this problem.The lack of diagnostic tools, such as the CAM, has contributed to low rates of diagnosis and index of suspicion among clinicians.
Objectives were To determine the incidence and perioperative factors associated with postoperative delirium in adult patients undergoing elective surgery in Mulago National Referral Hospital (MNRH) Procedure Patient recruitment Patients were stratified by ward and then systematic sampling was used with a sampling interval of 3. On each day of recruitment, the first 3 patients on the theatre list on a particular ward were selected by writing numbers 1 to 3 on pieces of paper and randomly selecting one; the number selected would be the first to be enrolled, succeeded by every 3rd patient on the theatre list for that day. Written informed consent was obtained preoperatively from each study patient.
Preoperative assessment Trained research assistants conducted the preoperative interviews with a questionnaire within 12 hours before surgery. Patient demographics, pain scores, Glasgow coma scores, smoking history, alcohol consumption, anaesthetic history, American Society of Anaesthesiologists (ASA), Class as recorded on the anaesthetic chart, vitals and laboratory results of complete blood count, renal and liver functional tests available were recorded.
Delirium assessment To determine the presence of delirium, research assistants conducted structured interviews preoperatively and on the first three postoperative days between hours of 9am and 12 pm, using the Confusion Assessment Method (CAM). Based on a structured interview, the CAM algorithm included four clinical criteria: acute onset and fluctuating course, inattention, disorganized thinking, and altered level of consciousness. To define delirium, both the first and second criteria had to have been present, plus either criterion three or four. The research assistants were trained in CAM use.
To ensure consistency in the evaluation, each patient was evaluated by the same research assistant for all three interviews. All cases of incident delirium were validated by a second investigator. The investigators focused on delirium measurement on the first 3 days postoperatively, aiming to avoid loss to follow up as the majority of postoperative patients in our setting get discharged on the third postoperative day.
Associated factors Risk factors identified during the preoperative interviews included age, history of smoking and alcohol use, preoperative pain scores, medications, and electrolytes. Other factors including type of surgery, ASA classification, duration of anaesthesia, Intraoperative blood loss as recorded on the anaesthetic charts. Blood loss was estimated using the common method of adding up volumes of blood absorbed in the commonly used absorptive materials including the gauze pieces, sponges and the mops. Suction canisters measured pre and post operatively and calculated minus the irrigation used in the case. Then the total estimated intraoperative blood loss was charted on the anaesthetic chart, intraoperative medications were obtained from the anaesthetic chart.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients with surgical disease admitted on the surgical wards in Mulago National Referral Hospital scheduled for surgery during the study period who met the eligibility criteria
Key inclusion criteria (1 listed)
- All adult patients above 18 years who have consented to participate in the study and are fully conscious by the Glasgow coma scale
Key exclusion criteria (3 listed)
- Patients with psychiatric disease confirmed by medical documents, as these were unable to provide informed consent
- Patients undergoing neuro surgery and open heart surgery, as these patients were expected to remain intubated postoperatively, precluding cognitive assessments.
- Patients scheduled for emergency surgery. Sample size Estimation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence of postoperative delirium
Time frame: 72 hours
the CAM assessment tool was administered preoperative and then delirium assessed postoperatively at the times given above using a CAM diagnostic tool administered by research assistant.when the patient was CAM positive at any time they were discontinued from the study
1 secondary outcome
perioperative factors associated with postoperative delirium
Time frame: up to 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JOSHUA SEMPIIRA, MBCHB principal investigator
MAKERERE UNIVERSITY DEPARTMENT OF ANAETHESIA
DICKENS H AKENA, PHD study director
MAKERERE UNIVERSITY DEPARTMENT OF PSYCHIATRY
EMMANUEL T AYEBALE, MMED study director
MAKERERE UNIVERSITY DEPARTMENT OF ANAESTHESIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium, run by Makerere University at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of postoperative delirium (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2016.