Incidence and Outcome of Reintubation in the PACU

Sponsor
Shangkun Liu (200966) (Other)
Overall Status
Completed
CT.gov ID
NCT05341596
Collaborator
(none)
121,965
9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: repeat endotracheal intubation

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

Study Type:
Observational
Actual Enrollment :
121965 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Incidence and Outcome of Reintubation in the Postanesthesia Care Unit: a Single-center, Retrospective, Observational Matched Cohort Study in China
Actual Study Start Date :
Jan 1, 2020
Actual Primary Completion Date :
Aug 31, 2020
Actual Study Completion Date :
Oct 1, 2020

Arms and Interventions

Arm Intervention/Treatment
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.

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

matched group

Patients without RAP during the PACU stay were designated as the matched group

Outcome Measures

Primary Outcome Measures

  1. Duration of PACU stay [through study completion, an average of three months]

    From patient transfer into PACU to transfer out of PACU

  2. Length of postoperative stay [through study completion, an average of three months]

  3. Unanticipated ICU admission [through study completion, an average of three months]

    Unplanned transfer to the ICU

Secondary Outcome Measures

  1. Inpatient healthcare costs [through study completion, an average of three months]

    Any medical cost during hospital stay

  2. Length of stay [through study completion, an average of three months]

    The time of hospital length of stay

  3. Duration of postoperative monitoring [through study completion, an average of three months]

    The time of postoperative monitoring

  4. Readmission [through study completion, an average of three months]

    admission after hospital discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shangkun Liu (200966)

Investigators

  • Study Chair: Hui Xu, Tongji Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Shangkun Liu (200966), nurse manager, Tongji Hospital
ClinicalTrials.gov Identifier:
NCT05341596
Other Study ID Numbers:
  • TJ-IRB20170501
First Posted:
Apr 22, 2022
Last Update Posted:
Apr 22, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shangkun Liu (200966), nurse manager, Tongji Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 22, 2022