Incidence and Outcome of Reintubation in the PACU

April 15, 2022 updated by: Shangkun Liu (200966)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

121965

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of PACU stay
Time Frame: through study completion, an average of three months
From patient transfer into PACU to transfer out of PACU
through study completion, an average of three months
Length of postoperative stay
Time Frame: through study completion, an average of three months
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
through study completion, an average of three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inpatient healthcare costs
Time Frame: through study completion, an average of three months
Any medical cost during hospital stay
through study completion, an average of three months
Length of stay
Time Frame: through study completion, an average of three months
The time of hospital length of stay
through study completion, an average of three months
Duration of postoperative monitoring
Time Frame: through study completion, an average of three months
The time of postoperative monitoring
through study completion, an average of three months
Readmission
Time Frame: through study completion, an average of three months
admission after hospital discharge
through study completion, an average of three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shangkun Liu (200966)

Investigators

  • Study Chair: Hui Xu, Tongji Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

August 31, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

April 8, 2022

First Submitted That Met QC Criteria

April 15, 2022

First Posted (Actual)

April 22, 2022

Study Record Updates

Last Update Posted (Actual)

April 22, 2022

Last Update Submitted That Met QC Criteria

April 15, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ-IRB20170501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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