Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05341596
Other study ID # TJ-IRB20170501
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date October 1, 2020

Study information

Verified date April 2022
Source Tongji Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 121965
Est. completion date October 1, 2020
Est. primary completion date August 31, 2020
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients requiring stay in PACU Exclusion Criteria: - Patients were transferred directly from the operating room to the ward or icu - non-postoperative patient

Study Design


Intervention

Procedure:
repeat endotracheal intubation
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shangkun Liu (200966)

References & Publications (15)

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. — View Citation

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. — View Citation

Bruins 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. — View Citation

De 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. — View Citation

Gao 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. Review. — View Citation

Haritos 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. — View Citation

Ing 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. — View Citation

Lee 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. — View Citation

Liu 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. — View Citation

Menon 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. Epub 2012 Feb 10. — View Citation

Rujirojindakul 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. — View Citation

Siao-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.

Siddiqui 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. — View Citation

Tarrac SE. A description of intraoperative and postanesthesia complication rates. J Perianesth Nurs. 2006 Apr;21(2):88-96. Erratum in: J Perianesth Nurs. 2006 Jun;21(3):224. — View Citation

Ting 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. — View Citation

* Note: There are 15 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Duration of PACU stay From patient transfer into PACU to transfer out of PACU through study completion, an average of three months
Primary Length of postoperative stay through study completion, an average of three months
Primary Unanticipated ICU admission Unplanned transfer to the ICU through study completion, an average of three months
Secondary Inpatient healthcare costs Any medical cost during hospital stay through study completion, an average of three months
Secondary Length of stay The time of hospital length of stay through study completion, an average of three months
Secondary Duration of postoperative monitoring The time of postoperative monitoring through study completion, an average of three months
Secondary Readmission admission after hospital discharge through study completion, an average of three months
See also
  Status Clinical Trial Phase
Recruiting NCT03181620 - Sedation Administration Timing: Intermittent Dosing Reduces Time to Extubation N/A
Recruiting NCT04205058 - Coffee After Pancreatic Surgery N/A
Completed NCT06425601 - A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy N/A
Completed NCT02565420 - Saline Versus Lactated Ringer's Solution: The SOLAR Fluid Trial N/A
Recruiting NCT04519593 - ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma N/A
Completed NCT03662672 - Rib Raising for Post-operative Ileus N/A
Completed NCT03787849 - Epigenetics in PostOperative Pediatric Emergence Delirium N/A
Active, not recruiting NCT05886387 - a Bayesian Analysis of Three Randomised Clinical Trials of Intraoperative Ventilation
Not yet recruiting NCT06351475 - Efficacy of Intraoperative Use of 20% Albumin Combined With Ringer Lactate Versus Ringer Lactate During Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy N/A
Not yet recruiting NCT05052021 - The South African Coronavirus Disease of 2019 (COVID-19) Surgical Outcomes Study
Not yet recruiting NCT03591432 - A Trial Comparing Transnasal humidified Rapid insufflation Ventilatory Exchange (THRIVE) and Apneic Oxygenation With Facemask Ventilation in Elderly Patients Undergoing Induction of Anaesthesia. N/A
Not yet recruiting NCT03639012 - Outcomes of Carbohydrate Loading Paediatric Patients Preoperatively for Tonsillectomy and Adenoidectomy N/A
Not yet recruiting NCT03275324 - Use of Integrated Pulmonary Index to Predict Post-Operative Respiratory Adverse Events in High Risk Patients N/A
Recruiting NCT02763878 - Uncut Roux-en-y Anastomosis Reduce Postoperative Complication and Improve Nutritional Status After Distal Gastrectomy Phase 3
Completed NCT02891187 - Visits Versus Telephone Calls for Postoperative Care N/A
Completed NCT02947789 - Predictive Model for Postoperative Mortality N/A
Not yet recruiting NCT02542423 - Endocan Predictive Value in Postcardiac Surgery Acute Respiratory Failure. N/A
Completed NCT02766062 - Effects of Propofol and Sevoflurane on Early POCD in Elderly Patients With Metabolic Syndrome N/A
Recruiting NCT01934049 - Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty Phase 4
Enrolling by invitation NCT01744938 - Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice Phase 3