AnesthesiaNCT00308984
CARE--Childhood Awareness and Recall Evaluation
An observational study of Anesthesia, run by Medtronic - MITG at 3 sites in United States.
Trial summary
The purpose of this study is to describe the incidence of recall or awareness under anesthesia in children aged 5-15 by collecting anesthetic and post-operative follow-up data relating to intra-operative recall during general anesthesia. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Anesthesia
- How many people
- 1,784 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2006to May 2008
- 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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children 5-15 years of age scheduled for a surgical procedure that requires general anesthesia
Who may be able to join
- Children 5-15 years of age scheduled for a surgical procedure that requires general anesthesia.
- Children able to respond to and answer post-operative follow-up questions at 3 time intervals post anesthesia: prior to discharge from the post-operative recovery area (or within the first 24 hours following surgery as clinically indicated), 3 (+ 1) days and 14 (+ 2) days post-operatively.
- Ability to speak and understand English.
- Anticipated length of general anesthesia of at least 30 minutes.
Who cannot join
- Children with known cognitive or neurologic impairment, psychiatric illness or developmental delay consistent with inability to accurately or adequately respond to or answer post-operative follow-up recall questions relating to their anesthesia experience.
- Expectation that the child will remain endotracheally intubated beyond 24 hours postoperatively.
- Anticipated use of ketamine for anesthetic management.
- Children that have had surgery or general anesthesia within the past 6 months or it is anticipated that child will require additional surgeries within the 14 day study follow-up time period.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mott Children's Hospital, University of Michigan Health System
Ann Arbor, Michigan, 48109
Children's Hospital of Atlanta at Egleston, Emory University
Atlanta, Georgia, 30322
The Children's Hospital, University of Colorado School of Medicine
Denver, Colorado, 80218
About this study
Official title: Multi-Center Study on the Incidence of Intra-operative Awareness and Recall in the Pediatric Population Undergoing General Anesthesia: CARE--Childhood Awareness and Recall Evaluation
The purpose of this study is to describe the incidence of recall or awareness under anesthesia in children aged 5-15 by collecting anesthetic and post-operative follow-up data relating to intra-operative recall during general anesthesia.
The hypothesis is that the implementation of routine awareness follow-up evaluation in children undergoing general anesthesia will identify that the incidence of intra-operative awareness in children is equal to or greater than in adults.
Read the detailed description
Awareness, or the unwanted recall of intra-operative events occurring during general anesthesia, is a potentially avoidable anesthetic complication that poses the risk for psychological sequelae. While the reported incidence is 0.1-0.2% in adults, this translates to > 20,000 cases of awareness occurring in adults annually in the United States (Ekman, 2004; Myles, 2000; Sandin, 2000; Sebel, 2004; Myles, 2004). Patients who experience recall may subsequently exhibit post-traumatic stress and psychological symptoms (Sebel, 2004; Myles, 2004; Moerman, 1993; Lennmarken, 2002). Furthermore; studies have shown that up to 54% of adult patients worry about the possibility of awareness during surgery (Klafta, 1996). Subsequent to the recent studies on unintended intraoperative awareness and published data on the impact of Bispectral Index in preventing and detecting anesthesia awareness, the Joint Commission on Accreditation of Healthcare Organizations has classified intraoperative awareness as a sentinel event (2004).
Limited data are available regarding the incidence and consequences of awareness in children. Studies which are available have identified a significantly higher incidence of intraoperative recall in children than has been shown in adults. McKie reported an incidence of 5% factual recall in 202 patients aged 7-14 years in 1973 (1973). The incidence of dreaming was reported as 11%. Hobbs, in 1988, reported a 19% incidence of dreaming and no awareness in 120 pediatric patients who received the "Liverpool anesthetic technique" (N20, O2, relaxant). Ranta reported 0.4% awareness in 4800 patients aged 12 years or older, with the youngest patient demonstrating undisputed awareness at 20 years of age (1998). More recently, Lopez et. al., found an 8% incidence of awareness in children 6-16 years of age, with a significant relationship between multiple attempts to secure the airway and the likelihood of awareness (2004). Most recently, a study published in 2005 by Davidson, et. al., found an incidence of 0.8% in 864 children aged 5-12 years of age with general anesthesia as is practiced in Australia. Likely explanations for more frequent awareness in children include altered anesthetic pharmacology in children and differences in the practice of pediatric anesthesia.
Post-operative behavior changes including emergence delirium, general anxiety, nighttime crying, enuresis, separation anxiety and temper tantrums have been described to occur up in to 50% of children undergoing surgery (Kain, 1996). Studies have also shown a correlation between pre-operative anxiety levels of both the child and parents, and may result in a greater risk of emergence delirium and later maladaptive behaviors. These results have not demonstrated a cause-effect relationship (Kain, 2004). Evaluating for intra-operative awareness or unwanted recall of intra-operative events with or without depth of anesthesia monitoring, may add to the knowledge base for causal factors in postoperative maladaptive behavior changes in the pediatric population.
The JCAHO Sentinel Event Alert, Issue 32, dated October 6, 2004, describes recommendations for health care organizations which perform procedures under general anesthesia, for the prevention and detection of intra-operative awareness. Specific recommendations include: identification of patients who are at higher risk for intraoperative awareness, appropriate follow-up of all patients, including children, who have undergone general anesthesia, and identification, management and, if appropriate, referral of patients who have experienced awareness.
Since little data exists on the incidence and identification of intra-operative awareness in children, this multi-center, prospective, observational, cohort evaluation is being conducted to describe and evaluate the incidence of awareness during routine general anesthetic practice in children. Following IRB approved informed consent (and assent as appropriate), children will sequentially be enrolled to participate in the study. Participating institutions will share de-identified data of enrolled pediatric patients undergoing general anesthesia. Each center will collect and maintain patient data in compliance with all privacy and institutional guidelines.
- Conditions
- Anesthesia
- Keywords
- Pediatrics, Intraoperative Awareness, Pediatric Anesthesia
- Medical subject headings
- Intraoperative Awareness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2006 (estimated)
- Study startJan 2006
- Primary completionDec 2007
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- 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
- 1,784 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shobha Malviya, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308984
- Sponsor's protocol ID
- 225
- Status last verified
- Mar 2012
- First submitted
- 28 Mar 2006
- Last updated
- 7 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Ekman A, Lindholm ML, Lennmarken C, Sandin R. Reduction in the incidence of awareness using BIS monitoring. Acta Anaesthesiol Scand. 2004 Jan;48(1):20-6. doi: 10.1111/j.1399-6576.2004.00260.x.
PubMed 14674969Myles PS, Williams DL, Hendrata M, Anderson H, Weeks AM. Patient satisfaction after anaesthesia and surgery: results of a prospective survey of 10,811 patients. Br J Anaesth. 2000 Jan;84(1):6-10. doi: 10.1093/oxfordjournals.bja.a013383.
PubMed 10740539Sandin RH, Enlund G, Samuelsson P, Lennmarken C. Awareness during anaesthesia: a prospective case study. Lancet. 2000 Feb 26;355(9205):707-11. doi: 10.1016/S0140-6736(99)11010-9.
PubMed 10703802Sebel PS, Bowdle TA, Ghoneim MM, Rampil IJ, Padilla RE, Gan TJ, Domino KB. The incidence of awareness during anesthesia: a multicenter United States study. Anesth Analg. 2004 Sep;99(3):833-839. doi: 10.1213/01.ANE.0000130261.90896.6C.
PubMed 15333419Myles PS, Leslie K, McNeil J, Forbes A, Chan MT. Bispectral index monitoring to prevent awareness during anaesthesia: the B-Aware randomised controlled trial. Lancet. 2004 May 29;363(9423):1757-63. doi: 10.1016/S0140-6736(04)16300-9.
PubMed 15172773Moerman N, Bonke B, Oosting J. Awareness and recall during general anesthesia. Facts and feelings. Anesthesiology. 1993 Sep;79(3):454-64. doi: 10.1097/00000542-199309000-00007.
PubMed 8363069Lennmarken C, Bildfors K, Enlund G, Samuelsson P, Sandin R. Victims of awareness. Acta Anaesthesiol Scand. 2002 Mar;46(3):229-31. doi: 10.1034/j.1399-6576.2002.t01-1-460301.x.
PubMed 11939910Klafta JM, Roizen MF. Current understanding of patients' attitudes toward and preparation for anesthesia: a review. Anesth Analg. 1996 Dec;83(6):1314-21. doi: 10.1097/00000539-199612000-00031.
PubMed 8942605Preventing, and managing the impact of, anesthesia awareness. Sentinel Event Alert. 2004 Oct 6;(32):1-3. No abstract available.
PubMed 15470805McKie BD, Thorp EA. Awareness and dreaming during anaesthesia in a paediatric hospital. Anaesth Intensive Care. 1973 Aug;1(5):407-14. doi: 10.1177/0310057X7300100507. No abstract available.
PubMed 4761535Hobbs AJ, Bush GH, Downham DY. Peri-operative dreaming and awareness in children. Anaesthesia. 1988 Jul;43(7):560-2. doi: 10.1111/j.1365-2044.1988.tb06687.x.
PubMed 3414918Ranta SO, Laurila R, Saario J, Ali-Melkkila T, Hynynen M. Awareness with recall during general anesthesia: incidence and risk factors. Anesth Analg. 1998 May;86(5):1084-9. doi: 10.1097/00000539-199805000-00035.
PubMed 9585303Lopez U, Iselin-Chavez I, Habre W. Incidence of awareness during general anaesthesia in children. Br J Anaesth. 2004; 93(3):490P-491P.
Davidson AJ, Huang GH, Czarnecki C, Gibson MA, Stewart SA, Jamsen K, Stargatt R. Awareness during anesthesia in children: a prospective cohort study. Anesth Analg. 2005 Mar;100(3):653-661. doi: 10.1213/01.ANE.0000150604.73481.00.
PubMed 15728046Kain ZN, Caldwell-Andrews AA, Maranets I, McClain B, Gaal D, Mayes LC, Feng R, Zhang H. Preoperative anxiety and emergence delirium and postoperative maladaptive behaviors. Anesth Analg. 2004 Dec;99(6):1648-1654. doi: 10.1213/01.ANE.0000136471.36680.97.
PubMed 15562048
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Study on the Incidence of Intra-operative Awareness and Recall in the Pediatric Population Undergoing General Anesthesia: CARE--Childhood Awareness and Recall Evaluation
- ClinicalTrials.gov ID
- NCT00308984
- Acronym / sponsor ID
- 225
- Conditions
- Anesthesia
- Keywords
- Pediatrics, Intraoperative Awareness, Pediatric Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,784 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 30 Mar 2006 (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.
The purpose of this study is to describe the incidence of recall or awareness under anesthesia in children aged 5-15 by collecting anesthetic and post-operative follow-up data relating to intra-operative recall during general anesthesia.
The hypothesis is that the implementation of routine awareness follow-up evaluation in children undergoing general anesthesia will identify that the incidence of intra-operative awareness in children is equal to or greater than in adults.
Detailed description
Awareness, or the unwanted recall of intra-operative events occurring during general anesthesia, is a potentially avoidable anesthetic complication that poses the risk for psychological sequelae. While the reported incidence is 0.1-0.2% in adults, this translates to > 20,000 cases of awareness occurring in adults annually in the United States (Ekman, 2004; Myles, 2000; Sandin, 2000; Sebel, 2004; Myles, 2004). Patients who experience recall may subsequently exhibit post-traumatic stress and psychological symptoms (Sebel, 2004; Myles, 2004; Moerman, 1993; Lennmarken, 2002). Furthermore; studies have shown that up to 54% of adult patients worry about the possibility of awareness during surgery (Klafta, 1996). Subsequent to the recent studies on unintended intraoperative awareness and published data on the impact of Bispectral Index in preventing and detecting anesthesia awareness, the Joint Commission on Accreditation of Healthcare Organizations has classified intraoperative awareness as a sentinel event (2004).
Limited data are available regarding the incidence and consequences of awareness in children. Studies which are available have identified a significantly higher incidence of intraoperative recall in children than has been shown in adults. McKie reported an incidence of 5% factual recall in 202 patients aged 7-14 years in 1973 (1973). The incidence of dreaming was reported as 11%. Hobbs, in 1988, reported a 19% incidence of dreaming and no awareness in 120 pediatric patients who received the "Liverpool anesthetic technique" (N20, O2, relaxant). Ranta reported 0.4% awareness in 4800 patients aged 12 years or older, with the youngest patient demonstrating undisputed awareness at 20 years of age (1998). More recently, Lopez et. al., found an 8% incidence of awareness in children 6-16 years of age, with a significant relationship between multiple attempts to secure the airway and the likelihood of awareness (2004). Most recently, a study published in 2005 by Davidson, et. al., found an incidence of 0.8% in 864 children aged 5-12 years of age with general anesthesia as is practiced in Australia. Likely explanations for more frequent awareness in children include altered anesthetic pharmacology in children and differences in the practice of pediatric anesthesia.
Post-operative behavior changes including emergence delirium, general anxiety, nighttime crying, enuresis, separation anxiety and temper tantrums have been described to occur up in to 50% of children undergoing surgery (Kain, 1996). Studies have also shown a correlation between pre-operative anxiety levels of both the child and parents, and may result in a greater risk of emergence delirium and later maladaptive behaviors. These results have not demonstrated a cause-effect relationship (Kain, 2004). Evaluating for intra-operative awareness or unwanted recall of intra-operative events with or without depth of anesthesia monitoring, may add to the knowledge base for causal factors in postoperative maladaptive behavior changes in the pediatric population.
The JCAHO Sentinel Event Alert, Issue 32, dated October 6, 2004, describes recommendations for health care organizations which perform procedures under general anesthesia, for the prevention and detection of intra-operative awareness. Specific recommendations include: identification of patients who are at higher risk for intraoperative awareness, appropriate follow-up of all patients, including children, who have undergone general anesthesia, and identification, management and, if appropriate, referral of patients who have experienced awareness.
Since little data exists on the incidence and identification of intra-operative awareness in children, this multi-center, prospective, observational, cohort evaluation is being conducted to describe and evaluate the incidence of awareness during routine general anesthetic practice in children. Following IRB approved informed consent (and assent as appropriate), children will sequentially be enrolled to participate in the study. Participating institutions will share de-identified data of enrolled pediatric patients undergoing general anesthesia. Each center will collect and maintain patient data in compliance with all privacy and institutional guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children 5-15 years of age scheduled for a surgical procedure that requires general anesthesia
Key inclusion criteria (4 listed)
- Children 5-15 years of age scheduled for a surgical procedure that requires general anesthesia.
- Children able to respond to and answer post-operative follow-up questions at 3 time intervals post anesthesia: prior to discharge from the post-operative recovery area (or within the first 24 hours following surgery as clinically indicated), 3 (+ 1) days and 14 (+ 2) days post-operatively.
- Ability to speak and understand English.
- Anticipated length of general anesthesia of at least 30 minutes.
Key exclusion criteria (4 listed)
- Children with known cognitive or neurologic impairment, psychiatric illness or developmental delay consistent with inability to accurately or adequately respond to or answer post-operative follow-up recall questions relating to their anesthesia experience.
- Expectation that the child will remain endotracheally intubated beyond 24 hours postoperatively.
- Anticipated use of ketamine for anesthetic management.
- Children that have had surgery or general anesthesia within the past 6 months or it is anticipated that child will require additional surgeries within the 14 day study follow-up time period.
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
Not reported in the source record.
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 7 Mar 2012.
- Background: PubMed 14674969Ekman A, Lindholm ML, Lennmarken C, Sandin R. Reduction in the incidence of awareness using BIS monitoring. Acta Anaesthesiol Scand. 2004 Jan;48(1):20-6. doi: 10.1111/j.1399-6576.2004.00260.x.
- Background: PubMed 10740539Myles PS, Williams DL, Hendrata M, Anderson H, Weeks AM. Patient satisfaction after anaesthesia and surgery: results of a prospective survey of 10,811 patients. Br J Anaesth. 2000 Jan;84(1):6-10. doi: 10.1093/oxfordjournals.bja.a013383.
- Background: PubMed 10703802Sandin RH, Enlund G, Samuelsson P, Lennmarken C. Awareness during anaesthesia: a prospective case study. Lancet. 2000 Feb 26;355(9205):707-11. doi: 10.1016/S0140-6736(99)11010-9.
- Background: PubMed 15333419Sebel PS, Bowdle TA, Ghoneim MM, Rampil IJ, Padilla RE, Gan TJ, Domino KB. The incidence of awareness during anesthesia: a multicenter United States study. Anesth Analg. 2004 Sep;99(3):833-839. doi: 10.1213/01.ANE.0000130261.90896.6C.
- Background: PubMed 15172773Myles PS, Leslie K, McNeil J, Forbes A, Chan MT. Bispectral index monitoring to prevent awareness during anaesthesia: the B-Aware randomised controlled trial. Lancet. 2004 May 29;363(9423):1757-63. doi: 10.1016/S0140-6736(04)16300-9.
- Background: PubMed 8363069Moerman N, Bonke B, Oosting J. Awareness and recall during general anesthesia. Facts and feelings. Anesthesiology. 1993 Sep;79(3):454-64. doi: 10.1097/00000542-199309000-00007.
- Background: PubMed 11939910Lennmarken C, Bildfors K, Enlund G, Samuelsson P, Sandin R. Victims of awareness. Acta Anaesthesiol Scand. 2002 Mar;46(3):229-31. doi: 10.1034/j.1399-6576.2002.t01-1-460301.x.
- Background: PubMed 8942605Klafta JM, Roizen MF. Current understanding of patients' attitudes toward and preparation for anesthesia: a review. Anesth Analg. 1996 Dec;83(6):1314-21. doi: 10.1097/00000539-199612000-00031.
- Background: PubMed 15470805Preventing, and managing the impact of, anesthesia awareness. Sentinel Event Alert. 2004 Oct 6;(32):1-3. No abstract available.
- Background: PubMed 4761535McKie BD, Thorp EA. Awareness and dreaming during anaesthesia in a paediatric hospital. Anaesth Intensive Care. 1973 Aug;1(5):407-14. doi: 10.1177/0310057X7300100507. No abstract available.
- Background: PubMed 3414918Hobbs AJ, Bush GH, Downham DY. Peri-operative dreaming and awareness in children. Anaesthesia. 1988 Jul;43(7):560-2. doi: 10.1111/j.1365-2044.1988.tb06687.x.
- Background: PubMed 9585303Ranta SO, Laurila R, Saario J, Ali-Melkkila T, Hynynen M. Awareness with recall during general anesthesia: incidence and risk factors. Anesth Analg. 1998 May;86(5):1084-9. doi: 10.1097/00000539-199805000-00035.
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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.
Shobha Malviya, MD principal investigator
University of Michigan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Medtronic - MITG at 3 sites in United States.
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 4 inclusion and 4 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 7 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00308984, which also lists 17 linked publications.
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 7 Mar 2012.