Postoperative ComplicationsNCT05341596
Incidence and Outcome of Reintubation in the PACU
An observational study of Postoperative Complications and Complication of Medical Care, run by Shangkun Liu (200966).
Trial summary
This study evaluated the occurrence of reintubation after planned extubation (RAP), the impact of RAP on duration of PACU stay,length of stay,length of postoperative stay,inpatient healthcare costs, unanticipated ICU admission and readmission. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Complications, Complication of Medical Care
- What is being tested?
- repeat endotracheal intubation
- Type of treatment
- Surgery or procedure
- How many people
- 121,965 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 1 Oct 2020
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Reintubation after planned extubation was defined as repeat endotracheal intubation in the PACU after planned extubation of the initial endotracheal intubation for general anesthesia or combined general anesthesia other than that performed in the operating room.
Who may be able to join
- Patients requiring stay in PACU
Who cannot join
- Patients were transferred directly from the operating room to the ward or icu
- non-postoperative patient
About this study
Official title: Incidence and Outcome of Reintubation in the Postanesthesia Care Unit: a Single-center, Retrospective, Observational Matched Cohort Study in China
This study evaluated the occurrence of reintubation after planned extubation (RAP), the impact of RAP on duration of PACU stay,length of stay,length of postoperative stay,inpatient healthcare costs, unanticipated ICU admission and readmission.
Read the detailed description
The study was carried out in Wuhan City, China at a general public university hospital with 62 clinical departments, 99 surgical rooms, and 38 beds in the PACU. The total number of operations performed in this hospital is more than 90,000/year. The study was approved by the hospital ethics committee and was deemed that written patient consent was not required. The adverse events, including RAP, in all patients in the PACU were recorded on a standardized form in a database by pre-trained qualified nurses and/or anesthesiologists at the time of care from January 1, 2017 to December 31, 2019.
Data, including patient demographic and surgical and anesthesia parameters, were obtained from the anesthesia information system. Adverse events management and duration of PACU stay were also documented. For three years, all collected data were filed in a computer every day and were summarized and analyzed every month. Data, such as demographics, airway, oxygen saturation, consciousness, treatment, vital signs, and fast-track criteria scores, were recorded for all patients in the PACU. The first part contained preoperative and intraoperative data, which were entered into the database by the anesthesiologists involved in the patients' intraoperative care from the time of PACU admission. The second part were recorded by nurse and comprised postoperative data from the PACU to the ward or ICU. The third part were recorded by the surgeons and/ or surgical nurses and comprised postoperative data. The criteria for tracheal extubation in the operating room(OR) and the timing of transfer to the PACU were the responsibility of the anesthesiologist.
- Being tested
- repeat endotracheal intubation
- Keywords
- general anesthesia, postanesthesia care unit, reintubation after planned extubation
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repeat endotracheal intubationProcedure or surgery
repeat endotracheal intubation in the PACU after planned extubation of the initial endotracheal intubation for general anesthesia or combined general anesthesia other than that performed in the operating room
| Study group | Role | What they receive |
|---|---|---|
| Reintubation after planned extubation | Reintubation after planned extubation(RAP) was defined as repeat endotracheal intubation in the PACU after planned extubation of the initial endotracheal intubation for general anesthesia or combined general anesthesia other than that performed in the operating room. Receives: Procedure: repeat endotracheal intubation | |
| matched group | Patients without RAP during the PACU stay were designated as the matched group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of PACU stay
From patient transfer into PACU to transfer out of PACU
Measured: through study completion, an average of three months
Length of postoperative stay
Measured: through study completion, an average of three months
Unanticipated ICU admission
Unplanned transfer to the ICU
Measured: through study completion, an average of three months
Secondary outcomes (4)
Inpatient healthcare costs
Any medical cost during hospital stay
Measured: through study completion, an average of three months
Length of stay
The time of hospital length of stay
Measured: through study completion, an average of three months
Duration of postoperative monitoring
The time of postoperative monitoring
Measured: through study completion, an average of three months
Readmission
admission after hospital discharge
Measured: through study completion, an average of three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 Jan 2020
- Primary completion31 Aug 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies 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
- Retrospective
- Enrolment
- 121,965 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shangkun Liu (200966)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shangkun Liu (200966), Tongji Hospital
- Investigators
- Hui Xu, Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341596
- Sponsor's protocol ID
- TJ-IRB20170501
- Status last verified
- Apr 2022
- First submitted
- 8 Apr 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Reintubation after planned extubation (RAP) is a serious adverse event. This study aimed to determine the rate and impact of RAP on postoperative course and hospitalization outcomes
Publications
American Society of Anesthesiologists Task Force on Postanesthetic Care. Practice guidelines for postanesthetic care: a report by the American Society of Anesthesiologists Task Force on Postanesthetic Care. Anesthesiology. 2002 Mar;96(3):742-52. doi: 10.1097/00000542-200203000-00033. No abstract available.
PubMed 11873052Tarrac SE. A description of intraoperative and postanesthesia complication rates. J Perianesth Nurs. 2006 Apr;21(2):88-96. doi: 10.1016/j.jopan.2006.01.006.
PubMed 16600829Siddiqui N, Arzola C, Teresi J, Fox G, Guerina L, Friedman Z. Predictors of desaturation in the postoperative anesthesia care unit: an observational study. J Clin Anesth. 2013 Dec;25(8):612-7. doi: 10.1016/j.jclinane.2013.04.018. Epub 2013 Oct 4.
PubMed 24095886Rujirojindakul P, Geater AF, McNeil EB, Vasinanukorn P, Prathep S, Asim W, Naklongdee J. Risk factors for reintubation in the post-anaesthetic care unit: a case-control study. Br J Anaesth. 2012 Oct;109(4):636-42. doi: 10.1093/bja/aes226. Epub 2012 Jul 9.
PubMed 22777658Haritos G, Smith CA, Haas RE, Becker A, Nguyen D, Stierer KA, Klein M. Critical Events Leading to Endotracheal Reintubation in the Postanesthesia Care Unit: A Retrospective Inquiry of Contributory Factors. AANA J. 2019 Feb;87(1):59-63.
PubMed 31587745Lee PJ, MacLennan A, Naughton NN, O'Reilly M. An analysis of reintubations from a quality assurance database of 152,000 cases. J Clin Anesth. 2003 Dec;15(8):575-81. doi: 10.1016/j.jclinane.2003.03.006.
PubMed 14724078Bruins SD, Leong PM, Ng SY. Retrospective review of critical incidents in the post-anaesthesia care unit at a major tertiary hospital. Singapore Med J. 2017 Aug;58(8):497-501. doi: 10.11622/smedj.2016126. Epub 2016 Jul 21.
PubMed 27439784Ting PC, Chou AH, Yang MW, Ho AC, Chang CJ, Chang SC. Postoperative reintubation after planned extubation: a review of 137,866 general anesthetics from 2005 to 2007 in a Medical Center of Taiwan. Acta Anaesthesiol Taiwan. 2010 Dec;48(4):167-71. doi: 10.1016/j.aat.2010.12.003. Epub 2010 Dec 22.
PubMed 21195986Siao-feng A, Tai-di Z, OU QH. Risk factors for postoperative reintubation in patients undergoing general anesthesia. Chin J Anesthesiol. 2013;33(12):1427-30.
Beverly A, Brovman EY, Malapero RJ, Lekowski RW, Urman RD. Unplanned Reintubation Following Cardiac Surgery: Incidence, Timing, Risk Factors, and Outcomes. J Cardiothorac Vasc Anesth. 2016 Dec;30(6):1523-1529. doi: 10.1053/j.jvca.2016.05.033. Epub 2016 May 21.
PubMed 27595531Menon N, Joffe AM, Deem S, Yanez ND, Grabinsky A, Dagal AH, Daniel S, Treggiari MM. Occurrence and complications of tracheal reintubation in critically ill adults. Respir Care. 2012 Oct;57(10):1555-63. doi: 10.4187/respcare.01617. Epub 2012 Feb 10.
PubMed 22324979Ing C, Chui I, Ohkawa S, Kakavouli A, Sun L. Incidence and causes of perioperative endotracheal reintubation in children: a review of 28,208 anesthetics. Paediatr Anaesth. 2013 Jul;23(7):621-6. doi: 10.1111/j.1460-9592.2012.03920.x. Epub 2012 Jul 23.
PubMed 22817271De la Garza Ramos R, Passias PG, Schwab F, Bydon A, Lafage V, Sciubba DM. Incidence, Risk Factors, and Mortality of Reintubation in Adult Spinal Deformity Surgery. Clin Spine Surg. 2017 Aug;30(7):E896-E900. doi: 10.1097/BSD.0000000000000404.
PubMed 27352366Gao F, Yang LH, He HR, Ma XC, Lu J, Zhai YJ, Guo LT, Wang X, Zheng J. The effect of reintubation on ventilator-associated pneumonia and mortality among mechanically ventilated patients with intubation: A systematic review and meta-analysis. Heart Lung. 2016 Jul-Aug;45(4):363-71. doi: 10.1016/j.hrtlng.2016.04.006.
PubMed 27377334Liu SK, Chen G, Yan B, Huang J, Xu H. Adverse Respiratory Events Increase Post-anesthesia Care Unit Stay in China: A 2-year Retrospective Matched Cohort Study. Curr Med Sci. 2019 Apr;39(2):325-329. doi: 10.1007/s11596-019-2038-y. Epub 2019 Apr 23.
PubMed 31016529
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Outcome of Reintubation in the Postanesthesia Care Unit: a Single-center, Retrospective, Observational Matched Cohort Study in China
- ClinicalTrials.gov ID
- NCT05341596
- Acronym / sponsor ID
- TJ-IRB20170501
- Keywords
- general anesthesia, postanesthesia care unit, reintubation after planned extubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121,965 participants (actual)
- Lead sponsor
- Shangkun Liu (200966)University, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 22 Apr 2022 (actual)
- 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.
This study evaluated the occurrence of reintubation after planned extubation (RAP), the impact of RAP on duration of PACU stay,length of stay,length of postoperative stay,inpatient healthcare costs, unanticipated ICU admission and readmission.
Detailed description
The study was carried out in Wuhan City, China at a general public university hospital with 62 clinical departments, 99 surgical rooms, and 38 beds in the PACU. The total number of operations performed in this hospital is more than 90,000/year. The study was approved by the hospital ethics committee and was deemed that written patient consent was not required. The adverse events, including RAP, in all patients in the PACU were recorded on a standardized form in a database by pre-trained qualified nurses and/or anesthesiologists at the time of care from January 1, 2017 to December 31, 2019.
Data, including patient demographic and surgical and anesthesia parameters, were obtained from the anesthesia information system. Adverse events management and duration of PACU stay were also documented. For three years, all collected data were filed in a computer every day and were summarized and analyzed every month. Data, such as demographics, airway, oxygen saturation, consciousness, treatment, vital signs, and fast-track criteria scores, were recorded for all patients in the PACU. The first part contained preoperative and intraoperative data, which were entered into the database by the anesthesiologists involved in the patients' intraoperative care from the time of PACU admission. The second part were recorded by nurse and comprised postoperative data from the PACU to the ward or ICU. The third part were recorded by the surgeons and/ or surgical nurses and comprised postoperative data. The criteria for tracheal extubation in the operating room(OR) and the timing of transfer to the PACU were the responsibility of the anesthesiologist.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reintubation after planned extubation | – | Procedure: repeat endotracheal intubationReintubation after planned extubation(RAP) was defined as repeat endotracheal intubation in the PACU after planned extubation of the initial endotracheal intubation for general anesthesia or combined general anesthesia other than that performed in the operating room. |
| matched group | – | –Patients without RAP during the PACU stay were designated as the matched group |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Reintubation after planned extubation was defined as repeat endotracheal intubation in the PACU after planned extubation of the initial endotracheal intubation for general anesthesia or combined general anesthesia other than that performed in the operating room.
Key inclusion criteria (1 listed)
- Patients requiring stay in PACU
Key exclusion criteria (2 listed)
- Patients were transferred directly from the operating room to the ward or icu
- non-postoperative patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| repeat endotracheal intubationrepeat endotracheal intubation in the PACU after planned extubation of the initial endotracheal intubation for general anesthesia or combined general anesthesia other than that performed in the operating room | Procedure or surgery | Reintubation after planned extubation |
Primary outcome
Duration of PACU stay
Time frame: through study completion, an average of three months
From patient transfer into PACU to transfer out of PACU
Length of postoperative stay
Time frame: through study completion, an average of three months
Unanticipated ICU admission
Time frame: through study completion, an average of three months
Unplanned transfer to the ICU
4 secondary outcomes
Inpatient healthcare costs
Time frame: through study completion, an average of three months
Length of stay
Time frame: through study completion, an average of three months
Duration of postoperative monitoring
Time frame: through study completion, an average of three months
Readmission
Time frame: through study completion, an average of three months
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 22 Apr 2022.
- Background: PubMed 11873052American Society of Anesthesiologists Task Force on Postanesthetic Care. Practice guidelines for postanesthetic care: a report by the American Society of Anesthesiologists Task Force on Postanesthetic Care. Anesthesiology. 2002 Mar;96(3):742-52. doi: 10.1097/00000542-200203000-00033. No abstract available.
- Background: PubMed 16600829Tarrac SE. A description of intraoperative and postanesthesia complication rates. J Perianesth Nurs. 2006 Apr;21(2):88-96. doi: 10.1016/j.jopan.2006.01.006.
- Background: PubMed 24095886Siddiqui N, Arzola C, Teresi J, Fox G, Guerina L, Friedman Z. Predictors of desaturation in the postoperative anesthesia care unit: an observational study. J Clin Anesth. 2013 Dec;25(8):612-7. doi: 10.1016/j.jclinane.2013.04.018. Epub 2013 Oct 4.
- Background: PubMed 22777658Rujirojindakul P, Geater AF, McNeil EB, Vasinanukorn P, Prathep S, Asim W, Naklongdee J. Risk factors for reintubation in the post-anaesthetic care unit: a case-control study. Br J Anaesth. 2012 Oct;109(4):636-42. doi: 10.1093/bja/aes226. Epub 2012 Jul 9.
- Background: PubMed 31587745Haritos G, Smith CA, Haas RE, Becker A, Nguyen D, Stierer KA, Klein M. Critical Events Leading to Endotracheal Reintubation in the Postanesthesia Care Unit: A Retrospective Inquiry of Contributory Factors. AANA J. 2019 Feb;87(1):59-63.
- Background: PubMed 14724078Lee PJ, MacLennan A, Naughton NN, O'Reilly M. An analysis of reintubations from a quality assurance database of 152,000 cases. J Clin Anesth. 2003 Dec;15(8):575-81. doi: 10.1016/j.jclinane.2003.03.006.
- Background: PubMed 27439784Bruins SD, Leong PM, Ng SY. Retrospective review of critical incidents in the post-anaesthesia care unit at a major tertiary hospital. Singapore Med J. 2017 Aug;58(8):497-501. doi: 10.11622/smedj.2016126. Epub 2016 Jul 21.
- Background: PubMed 21195986Ting PC, Chou AH, Yang MW, Ho AC, Chang CJ, Chang SC. Postoperative reintubation after planned extubation: a review of 137,866 general anesthetics from 2005 to 2007 in a Medical Center of Taiwan. Acta Anaesthesiol Taiwan. 2010 Dec;48(4):167-71. doi: 10.1016/j.aat.2010.12.003. Epub 2010 Dec 22.
- BackgroundSiao-feng A, Tai-di Z, OU QH. Risk factors for postoperative reintubation in patients undergoing general anesthesia. Chin J Anesthesiol. 2013;33(12):1427-30.
- Background: PubMed 27595531Beverly A, Brovman EY, Malapero RJ, Lekowski RW, Urman RD. Unplanned Reintubation Following Cardiac Surgery: Incidence, Timing, Risk Factors, and Outcomes. J Cardiothorac Vasc Anesth. 2016 Dec;30(6):1523-1529. doi: 10.1053/j.jvca.2016.05.033. Epub 2016 May 21.
- Background: PubMed 22324979Menon N, Joffe AM, Deem S, Yanez ND, Grabinsky A, Dagal AH, Daniel S, Treggiari MM. Occurrence and complications of tracheal reintubation in critically ill adults. Respir Care. 2012 Oct;57(10):1555-63. doi: 10.4187/respcare.01617. Epub 2012 Feb 10.
- Background: PubMed 22817271Ing C, Chui I, Ohkawa S, Kakavouli A, Sun L. Incidence and causes of perioperative endotracheal reintubation in children: a review of 28,208 anesthetics. Paediatr Anaesth. 2013 Jul;23(7):621-6. doi: 10.1111/j.1460-9592.2012.03920.x. Epub 2012 Jul 23.
- Individual participant dataSharing planned: No. Reintubation after planned extubation (RAP) is a serious adverse event. This study aimed to determine the rate and impact of RAP on postoperative course and hospitalization outcomes
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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.
Hui Xu study chair
Tongji Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications and Complication of Medical Care, run by Shangkun Liu (200966).
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 2 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 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Duration of PACU stay (time frame: through study completion, an average of three months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05341596, which also lists 15 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 22 Apr 2022.