Development and Validation of a Predictive Model for Postoperative Pulmonary Complications in Elderly Patients

Although several clinical predictive models have been developed to predict postoperative pulmonary complications, few predictive models have been developed for elderly patients. In this study, the researchers aimed to develop a new, simplified model to assess the risk of postoperative pulmonary complications in elderly patients using perioperative database information.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pulmonary Complications

Detailed Description

Postoperative pulmonary complications occur frequently, which is an important cause of death and morbidity. Age has always been an significant predictor of postoperative pulmonary complications. With an aging population worldwide, more and more elderly people are undergoing surgery due to the expansion of surgical indications. As a result of this phenomenon, the elderly are also an important group for the prediction and intervention of postoperative pulmonary complications. In order to better assess the risk of postoperative pulmonary complications in elderly patients, we constructed a model using database information.

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

• Study Contact: Name: Qingping Wu, PhD; Phone Number: 13971605283; Email: wqp1968@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Wuhan Union Hospital
      • Contact: Qingping Wu; Email: wqp1968@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

older patients received general anesthesia in Wuhan Union Hospital from January 1, 2014 to December 31, 2019.

Description

Inclusion Criteria:

• Age 65 years or older
• receiving invasive ventilation during general anesthesia for surgery

Exclusion Criteria:

• preoperative mechanical ventilation
• operations related to previous postoperative complications
• a second operation after surgery
• organ transplantation
• discharged within 24 hours after surgery
• cardiac and thoracic surgery

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Training set; The whole cohort is randomly assigned to a training cohort and validation cohort.
validation set; The whole cohort is randomly assigned to a training cohort and validation cohort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postoperative pulmonary complications	within one week after surgery

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2022
• Primary Completion (Anticipated): September 22, 2022
• Study Completion (Anticipated): September 22, 2022

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: August 16, 2022
• First Posted (Actual): August 18, 2022

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PPC20210110

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No