Postoperative Pulmonary ComplicationsNCT05519657
Incidence and Risk Factors of PPCs in Elderly Patients Undergoing Robot Assisted Laparoscopic Pelvic Surgery
An observational study of Postoperative Pulmonary Complications and Risk Factors, run by Tongji Hospital.
Trial summary
Postoperative pulmonary complications are important factors affecting the prognosis of patients undergoing surgery. Studies have shown that patients undergoing abdominal or pelvic surgery, emergency surgery, or prolonged surgery are more likely to develop PPCs, especially when robot-assisted laparoscopic surgery is… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Pulmonary Complications, Risk Factors
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Nov 2023
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Preoperative: age, sex, height, weight, ASA grade, smoking history, preoperative comorbidities (hypertension, diabetes, coronary heart disease, chronic kidney disease, cerebrovascular disease, COPD), medication history, pulse oxygen saturation, white blood cell count, hemoglobin level, albumin level. Intraoperative: operation time (cut skin to sew leather end), anesthesia time (anesthesia induction to tracheal extubation), mechanical ventilation parameters, completion of vital signs, muscle relaxant antagonism, whether the implementation of regional block, infusion, blood loss, amount of urine, perioperative medications (opioids dosage adjustments based on weight and anesthesia time).
Who may be able to join
- Age ≥65 years old
- Selective patients undergoing robot-assisted laparoscopic pelvic surgery under general anesthesia
Who cannot join
- Patients undergoing oxygen therapy or mechanical ventilation before surgery
- Patients who have received other surgical operations within 30 days
- Patients who have previously undergone lung surgery
About this study
Official title: Incidence and Risk Factors of Postoperative Pulmonary Complications in Elderly Patients Undergoing Robot Assisted Laparoscopic Pelvic Surgery: a Single Center, Prospective, Observational Study
Postoperative pulmonary complications are important factors affecting the prognosis of patients undergoing surgery. Studies have shown that patients undergoing abdominal or pelvic surgery, emergency surgery, or prolonged surgery are more likely to develop PPCs, especially when robot-assisted laparoscopic surgery is performed at extreme head low. The incidence of PPCs and associated risk factors in patients undergoing robot-assisted laparoscopic surgery compared with those undergoing conventional surgery should be re-examined.
Read the detailed description
PPCs include bronchospasm, atelectasis, lung infections (bronchitis and pneumonia), exacerbation of pre-existing chronic lung disease, the need for mechanical ventilation after surgery, and respiratory failure. Risk factors for PPCs include preoperative and intraoperative factors. Preoperative was mainly related to the primary status of patients, including age, weight, ASA grade, organ function status, medication history, hypoproteinemia, and concomitant chronic kidney disease, congestive heart failure, COPD, asthma, pulmonary interstitial disease, pulmonary hypertension, and OSA. In this study, elderly patients undergoing robot-assisted laparoscopic pelvic surgery under general anesthesia were selected to prospectively collect basic characteristics, preoperative examination results and perioperative data, and determine the incidence and risk factors of PPCs in this high-risk population cohort. The aim of our study was to determine the incidence of PPCs in elderly patients undergoing robot-assisted laparoscopic pelvic surgery and to screen for associated risk factors.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| postoperative pulmonary complications group | Postoperative pulmonary complications group no intervention | |
| non-postoperative pulmonary complications group | Non-postoperative pulmonary complications group no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PPCs
One or more of the following conditions occurred: clinically diagnosed PPCs (pneumonia, bronchospasm, ARDS), radiographically diagnosed PPCs (atelectasis, pneumothorax, pleural effusion), postoperative respiratory insufficiency (requiring oxygen or non-invasive mechanical ventilation for more than 1 day), and postoperative tracheal intubation again;Respiratory infections: new or altered sputum properties, new or altered lung shadows, fever, white blood cell >12 × 109/L;Respiratory failure: partial pressure of oxygen in the arterial blood while inhaling air< 60 mmHg, pulse oxygen saturation< 90%, or PaO2/FiO2 < 300;Atelectasis, pneumothorax, pleural effusion: Chest X - ray diagnosis;Bronchospasm: wheezing sound can be relieved with bronchodilators.
Measured: Up to 7 days
Secondary outcomes (1)
Risk factors of PPCs
Risk factors of PPCs in elderly patients undergoing robot assisted laparoscopic pelvic surgery
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pulmonary ComplicationsStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Gao, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519657
- Sponsor's protocol ID
- TJ2021S127
- Status last verified
- Aug 2022
- First submitted
- 9 Jul 2021
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factors of Postoperative Pulmonary Complications in Elderly Patients Undergoing Robot Assisted Laparoscopic Pelvic Surgery: a Single Center, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT05519657
- Acronym / sponsor ID
- TJ2021S127
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 29 Aug 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.
Postoperative pulmonary complications are important factors affecting the prognosis of patients undergoing surgery. Studies have shown that patients undergoing abdominal or pelvic surgery, emergency surgery, or prolonged surgery are more likely to develop PPCs, especially when robot-assisted laparoscopic surgery is performed at extreme head low. The incidence of PPCs and associated risk factors in patients undergoing robot-assisted laparoscopic surgery compared with those undergoing conventional surgery should be re-examined.
Detailed description
PPCs include bronchospasm, atelectasis, lung infections (bronchitis and pneumonia), exacerbation of pre-existing chronic lung disease, the need for mechanical ventilation after surgery, and respiratory failure. Risk factors for PPCs include preoperative and intraoperative factors. Preoperative was mainly related to the primary status of patients, including age, weight, ASA grade, organ function status, medication history, hypoproteinemia, and concomitant chronic kidney disease, congestive heart failure, COPD, asthma, pulmonary interstitial disease, pulmonary hypertension, and OSA. In this study, elderly patients undergoing robot-assisted laparoscopic pelvic surgery under general anesthesia were selected to prospectively collect basic characteristics, preoperative examination results and perioperative data, and determine the incidence and risk factors of PPCs in this high-risk population cohort. The aim of our study was to determine the incidence of PPCs in elderly patients undergoing robot-assisted laparoscopic pelvic surgery and to screen for associated risk factors.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postoperative pulmonary complications group | – | –Postoperative pulmonary complications group no intervention |
| non-postoperative pulmonary complications group | – | –Non-postoperative pulmonary complications group no intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Preoperative: age, sex, height, weight, ASA grade, smoking history, preoperative comorbidities (hypertension, diabetes, coronary heart disease, chronic kidney disease, cerebrovascular disease, COPD), medication history, pulse oxygen saturation, white blood cell count, hemoglobin level, albumin level. Intraoperative: operation time (cut skin to sew leather end), anesthesia time (anesthesia induction to tracheal extubation), mechanical ventilation parameters, completion of vital signs, muscle relaxant antagonism, whether the implementation of regional block, infusion, blood loss, amount of urine, perioperative medications (opioids dosage adjustments based on weight and anesthesia time).
Key inclusion criteria (2 listed)
- Age ≥65 years old
- Selective patients undergoing robot-assisted laparoscopic pelvic surgery under general anesthesia
Key exclusion criteria (3 listed)
- Patients undergoing oxygen therapy or mechanical ventilation before surgery
- Patients who have received other surgical operations within 30 days
- Patients who have previously undergone lung surgery
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 |
|---|---|---|
| Other | non-postoperative pulmonary complications group |
Primary outcome
Incidence of PPCs
Time frame: Up to 7 days
One or more of the following conditions occurred: clinically diagnosed PPCs (pneumonia, bronchospasm, ARDS), radiographically diagnosed PPCs (atelectasis, pneumothorax, pleural effusion), postoperative respiratory insufficiency (requiring oxygen or non-invasive mechanical ventilation for more than 1 day), and postoperative tracheal intubation again;Respiratory infections: new or altered sputum properties, new or altered lung shadows, fever, white blood cell >12 × 109/L;Respiratory failure: partial pressure of oxygen in the arterial blood while inhaling air< 60 mmHg, pulse oxygen saturation< 90%, or PaO2/FiO2 < 300;Atelectasis, pneumothorax, pleural effusion: Chest X - ray diagnosis;Bronchospasm: wheezing sound can be relieved with bronchodilators.
1 secondary outcome
Risk factors of PPCs
Time frame: Up to 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pulmonary Complications and Risk Factors, run by Tongji Hospital.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Aug 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?
Results are not available in the source record.
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?
Incidence of PPCs (time frame: Up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2022.