Colorectal SurgeryNCT06662799
Dorsal Vetilation and PPCs in Colorectal Cancer Surgery Patients
An observational study of Colorectal Surgery and Postoperative Pulmonary Complications (PPCs), run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
Postoperative pulmonary complications (PPCs) are common in patients after major abdominal surgery. It has been shown that 5-40% of patients occur PPCs after major surgery, and the mid to high PPC rate is observed after laparoscopic colorectal cancer surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Surgery, Postoperative Pulmonary Complications (PPCs)
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 25 Dec 2024
- How long will I take part?
- 10 Days
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing laparoscopic colorectal cancer surgery
Who may be able to join
- Age ≥18 years
- ASA grade I-III
- The patients who are planning to undergo laparoscopic colorectal cancer surgery
Who cannot join
- Emergency surgery
- Time of surgery less than 2 hours
- Preoperatively present upper respiratory tract infection or acute pulmonary infection
- Previous history of pulmonary surgery
- Preoperative use of home ventilator
- Inability to perform EIT monitoring
- Declined to participate in this study
Trial locations and contacts
1 site in 1 country.
China1 site
The first Affiliated Hospital, School of Medicine, Zhejiang University.
Hangzhou, Zhejiang, 310000
About this study
Official title: Intraoperative Reduction of Ventilation of Dorsal Lung Regions and Postoperative Pulmonary Complications After Laparoscopic Colorectal Cancer Surgery
Postoperative pulmonary complications (PPCs) are common in patients after major abdominal surgery. It has been shown that 5-40% of patients occur PPCs after major surgery, and the mid to high PPC rate is observed after laparoscopic colorectal cancer surgery. PPCs are associated with poor clinical outcomes including prolonged hospital length of stay and increased morbidity and mortality.
Mechanical ventilation during general anesthesia can lead to a redistribution of ventilation, increase the aereation in the ventral parts of the lung, whereas reduce ventilation in the dorsal parts of the lung compared with spontaneous breathing (SB) in the awake state in supine position. The reduction of ventilation of dorsal lung regions indicates the presence of dorsal atelectasis during mechanical ventilation after general anesthesia, which may be associated with PPCs. However, there is still no evidence to reveal the association between the reduction of dorsal ventilation and PPCs.
Read more
Recently, electrical impedance tomography (EIT), which allows visualization of lung ventilation in real time, and assessment of regional lung ventilation. It is feasible to assess the change of ventral/dorsal lung ventilation during the surgery using EIT. To date, no study has investigated whether the change of ventral/dorsal lung ventilation revealed by EIT could be associated with PPCs.
So, this prospective observational study aims to clarify whether patients developing postoperative pulmonary complications had higher reduction of dorsal lung ventilation during operation after general anesthesia as compared to patients not developing postoperative pulmonary complications. Ratio of dorsal ventilation during spontaneous respiration (T0) in the awake state as a reference, the proportion of dorsal ventilation after anesthesia induction and endotracheal intubation (T1), body position change and capnoperitoneum (T2), and at the end of surgery (T3) were analyzed. Thereafter, evaluating the change of dorsal ventilation in patients with PPCs and without PPCs at different time points.
According to the method of sample size calculation published by Scaramuzzo G et al. (Anesthesiology. 2024 Oct 1;141(4):693-706.). A minimum sample size required for this study was calculated as following: using the difference of reduction of dorsal ventilation at the end of surgery between the patients with PPCs and non-PPCs as the primary outcome. Considering the data of our preliminary experiment showed that a reduction of dorsal lung ventilation at the end of surgery is 12 ± 6% and hypothesizing 30% of patients experiencing postoperative pulmonary complications and a relative clinically relevant increase in reduction of dorsal lung ventilation of 40% in those with postoperative pulmonary complications, we found that 83 patients were sufficient to evaluate differences between groups (effect size 0.8) with a power of 0.90 and an α error of 0.05. Considering a dropout of 10%, we found a minimum sample size of 92 patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of reduction of dorsal ventilation at the end of surgery between the patients with PPCs and non-PPCs
- EIT to monitor the regional ventilation of the patients at spontaneous breathing (SB) in the awake state in supine position (T0) and the end of surgery (T3). The reduction of the ratio of dorsal ventilation will be caculated between T3 and T0.
- Follow-up the patients untill discharge from the hostiptal. Based on whether pulmonary complication occurs during 7 days after surgery, the participants will be divided into the patients with PPCs and the patients with non-PPCs.
- The difference of reduction of dorsal ventilation at the end of surgery (T3) between the patients with PPCs and non-PPCs will be analyzed.
Measured: 1-7 days after surgery.
Secondary outcomes (3)
The difference of reduction of dorsal ventilation at endotracheal intubation after general anesthesia induction between the patients with PPCs and non-PPCs
EIT to monitor the regional ventilation of the patients at spontaneous breathing (SB) in the awake state in supine position (T0) and endotracheal intubation after general anesthesia induction (T1). The reduction of the ratio of dorsal ventilation will be caculated between T1 and T0. 2. Follow-up the patients untill discharge from the hostiptal. Based on whether pulmonary complication occurs during 7 days after surgery, the participants will be divided into the patients with PPCs and the patients with non-PPCs. 3. The difference of reduction of dorsal ventilation at endotracheal intubation after general anesthesia induction (T1) between the patients with PPCs and non-PPCs will be analyzed.
Measured: 1-7 days after surgery.
The difference of reduction of dorsal ventilation at pneumoperitoneum and body position change between the patients with PPCs and non-PPCs
EIT to monitor the regional ventilation of the patients at spontaneous breathing (SB) in the awake state in supine position (T0) and pneumoperitoneum and body position change (T2). The reduction of the ratio of dorsal ventilation will be caculated between T2 and T0. 2. Follow-up the patients untill discharge from the hostiptal. Based on whether pulmonary complication occurs during 7 days after surgery, the participants will be divided into the patients with PPCs and the patients with non-PPCs. 3. The difference of reduction of dorsal ventilation at pneumoperitoneum and body position change (T2) between the patients with PPCs and non-PPCs will be analyzed.
Measured: 1-7 days after surgery.
The risk factors which are associated with PPCs
- Collecting age, gender, height, weight, history of chronic diseases such as hypertension and chronic obstructive pulmonary disease (COPD) etal, and assessing the pre-operative respiratory risk of patients using the ARISCAT (Assess Respiratory Risk in Surgical Patients in Catalonia) scoring system developed by Canet J et al.
- To explore the independent risk factors which are associated with PPCs using logistic regression.
Measured: 1-7 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 Jul 2024
- Primary completion15 Dec 2024
- Study completion25 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xiangming fang, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662799
- Sponsor's protocol ID
- IIT20240443B
- Status last verified
- Dec 2024
- First submitted
- 7 Oct 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu S, Cui P, Wang B, Shui W, Chu L, Fang X, Xie G. Intraoperative dorsal lung ventilation reduction and postoperative pulmonary complications after laparoscopic colorectal cancer surgery: A prospective cohort study. Chin Med J (Engl). 2026 Aug 14. doi: 10.1097/CM9.0000000000004197. Online ahead of print.
PubMed 42604997
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Reduction of Ventilation of Dorsal Lung Regions and Postoperative Pulmonary Complications After Laparoscopic Colorectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT06662799
- Acronym / sponsor ID
- IIT20240443B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 25 Dec 2024 (actual)
- First posted
- 29 Oct 2024 (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 (PPCs) are common in patients after major abdominal surgery. It has been shown that 5-40% of patients occur PPCs after major surgery, and the mid to high PPC rate is observed after laparoscopic colorectal cancer surgery. PPCs are associated with poor clinical outcomes including prolonged hospital length of stay and increased morbidity and mortality.
Mechanical ventilation during general anesthesia can lead to a redistribution of ventilation, increase the aereation in the ventral parts of the lung, whereas reduce ventilation in the dorsal parts of the lung compared with spontaneous breathing (SB) in the awake state in supine position. The reduction of ventilation of dorsal lung regions indicates the presence of dorsal atelectasis during mechanical ventilation after general anesthesia, which may be associated with PPCs. However, there is still no evidence to reveal the association between the reduction of dorsal ventilation and PPCs.
Recently, electrical impedance tomography (EIT), which allows visualization of lung ventilation in real time, and assessment of regional lung ventilation. It is feasible to assess the change of ventral/dorsal lung ventilation during the surgery using EIT. To date, no study has investigated whether the change of ventral/dorsal lung ventilation revealed by EIT could be associated with PPCs.
So, this prospective observational study aims to clarify whether patients developing postoperative pulmonary complications had higher reduction of dorsal lung ventilation during operation after general anesthesia as compared to patients not developing postoperative pulmonary complications. Ratio of dorsal ventilation during spontaneous respiration (T0) in the awake state as a reference, the proportion of dorsal ventilation after anesthesia induction and endotracheal intubation (T1), body position change and capnoperitoneum (T2), and at the end of surgery (T3) were analyzed. Thereafter, evaluating the change of dorsal ventilation in patients with PPCs and without PPCs at different time points.
According to the method of sample size calculation published by Scaramuzzo G et al. (Anesthesiology. 2024 Oct 1;141(4):693-706.). A minimum sample size required for this study was calculated as following: using the difference of reduction of dorsal ventilation at the end of surgery between the patients with PPCs and non-PPCs as the primary outcome. Considering the data of our preliminary experiment showed that a reduction of dorsal lung ventilation at the end of surgery is 12 ± 6% and hypothesizing 30% of patients experiencing postoperative pulmonary complications and a relative clinically relevant increase in reduction of dorsal lung ventilation of 40% in those with postoperative pulmonary complications, we found that 83 patients were sufficient to evaluate differences between groups (effect size 0.8) with a power of 0.90 and an α error of 0.05. Considering a dropout of 10%, we found a minimum sample size of 92 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing laparoscopic colorectal cancer surgery
Key inclusion criteria (3 listed)
- Age ≥18 years
- ASA grade I-III
- The patients who are planning to undergo laparoscopic colorectal cancer surgery
Key exclusion criteria (7 listed)
- Emergency surgery
- Time of surgery less than 2 hours
- Preoperatively present upper respiratory tract infection or acute pulmonary infection
- Previous history of pulmonary surgery
- Preoperative use of home ventilator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The difference of reduction of dorsal ventilation at the end of surgery between the patients with PPCs and non-PPCs
Time frame: 1-7 days after surgery.
1. EIT to monitor the regional ventilation of the patients at spontaneous breathing (SB) in the awake state in supine position (T0) and the end of surgery (T3). The reduction of the ratio of dorsal ventilation will be caculated between T3 and T0. 2. Follow-up the patients untill discharge from the hostiptal. Based on whether pulmonary complication occurs during 7 days after surgery, the participants will be divided into the patients with PPCs and the patients with non-PPCs. 3. The difference of reduction of dorsal ventilation at the end of surgery (T3) between the patients with PPCs and non-PPCs will be analyzed.
3 secondary outcomes
The difference of reduction of dorsal ventilation at endotracheal intubation after general anesthesia induction between the patients with PPCs and non-PPCs
Time frame: 1-7 days after surgery.
The difference of reduction of dorsal ventilation at pneumoperitoneum and body position change between the patients with PPCs and non-PPCs
Time frame: 1-7 days after surgery.
The risk factors which are associated with PPCs
Time frame: 1-7 days after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Derived from this study: PubMed 42604997Wu S, Cui P, Wang B, Shui W, Chu L, Fang X, Xie G. Intraoperative dorsal lung ventilation reduction and postoperative pulmonary complications after laparoscopic colorectal cancer surgery: A prospective cohort study. Chin Med J (Engl). 2026 Aug 14. doi: 10.1097/CM9.0000000000004197. Online ahead of print.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Surgery and Postoperative Pulmonary Complications (PPCs), run by First Affiliated Hospital of Zhejiang University at 1 site in China.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The difference of reduction of dorsal ventilation at the end of surgery between the patients with PPCs and non-PPCs (time frame: 1-7 days after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06662799, which also lists 1 linked publication.
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 3 Jan 2025.