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Pulmonary ComplicationNCT06001411

Effect of Prone Position Training on Pulmonary Complications in Patients Undergoing Laparoscopic Colorectal Surgery

A study testing Prone Position Training in people with Pulmonary Complication, run by Min Su at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Colorectal cancer is a common digestive tract tumor in China. At present, laparoscopic surgery has become the classic operation of colorectal cancer surgery compared with the traditional open abdominal surgery. Although laparoscopic surgery has many advantages, such as less pain, faster recovery and so on. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Complication
What is being tested?
Prone Position Training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
140 participants
Where
1 siteChina
Study dates
21 Aug 2023to 6 Sep 2024
Phase
Interventional
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

Who may be able to join

  • age over 18 years old
  • Clinical diagnosis of colorectal cancer

Who cannot join

  • Emergency surgery
  • Cognitive dysfunction
  • American Society of Anesthesiologists class ⩾IV
  • Fractures (face, collarbone, ribs, spine, limbs)
  • History of spontaneous pneumothorax
  • Increased intracranial pressure
Show all 12Show fewer
  • pregnancy
  • Systemic infection
  • Acute respiratory failure
  • Patients with hemodynamic instability
  • Other conditions that are not suitable for prone position
  • Failure to obtain informed consent

Trial locations and contacts

1 site in 1 country.

Dong Zhang, Master contact

+86-023-89011069

848138113@qq.com

China1 site
  • China,Chongqing The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

Other trials in China

About this study

Official title: Effect of Preoperative Prone Position Training on Postoperative Pulmonary Complications in Patients Undergoing Laparoscopic Colorectal Surgery

Colorectal cancer is a common digestive tract tumor in China. At present, laparoscopic surgery has become the classic operation of colorectal cancer surgery compared with the traditional open abdominal surgery. Although laparoscopic surgery has many advantages, such as less pain, faster recovery and so on. However, relevant studies have shown that postoperative pulmonary complications are more common in patients undergoing Laparoscopic Colorectal Surgery, which contribute to significant increases in morbidity, mortality, length of postoperative hospital stay and medical consumption.

The incidence of pulmonary complications after abdominal surgery has been reported to be between 9% and 40%.

Read more

The reduction in pulmonary volume and respiratory muscular activation after major abdominal surgery due to surgery-related shallow breathing, pain, long-term bed rest, mucociliary clearance disorder, and diaphragmatic dysfunction may be the main causes of postoperative pulmonary complications.

Numerous studies have demonstrated physiological improvement related to prone positioning. Prone positioning consists of placing a patient face down. Prone positioning has been used for to improve oxygenation in patients who require invasive mechanical ventilation for acute respiratory distress syndrome (ARDS). It has also been applied to non-intubated patients with acute respiratory failure (ARF), to improve oxygenation and delay or even avoid the need for invasive ventilation. So, the purpose of this study is to observe whether preoperative prone position training can reduce the incidence of pulmonary complications after laparoscopic colorectal cancer surgery.

Read the detailed description

Colorectal cancer is a common digestive tract tumor in China. At present, laparoscopic surgery has become the classic operation of colorectal cancer surgery compared with the traditional open abdominal surgery. Although laparoscopic surgery has many advantages, such as less pain, faster recovery. However, relevant studies have shown that postoperative pulmonary complications are more common in patients undergoing Laparoscopic Colorectal Surgery, which contribute to significant increases in morbidity, mortality, length of postoperative hospital stay and medical consumption.

Postoperative pulmonary complications (PPCs) refer to the clinical abnormal changes in the lungs after surgery, These include lung infections (pneumonia), atelectasis, pleural effusion, bronchospasm, acute respiratory failure or acute respiratory distress syndrome (ARDS). The incidence of pulmonary complications after abdominal surgery has been reported to be between 9% and 40%.

The reduction in pulmonary volume and respiratory muscular activation after major abdominal surgery due to surgery-related shallow breathing, pain, long-term bed rest, mucociliary clearance disorder, and diaphragmatic dysfunction may be the main causes of postoperative pulmonary complications.

Numerous studies have demonstrated physiological improvement related to prone positioning. Prone positioning consists of placing a patient face down. Prone positioning has been used for more than 40 years to improve oxygenation in patients who require invasive mechanical ventilation for acute respiratory distress syndrome (ARDS). Because of the positive physiological effects of prone positioning on transpulmonary pressure, lung compression and ventilation perfusion ratio, it has also been applied to non-intubated patients with acute respiratory failure (ARF), to improve oxygenation and delay or even avoid the need for invasive ventilation.

Currently, the mechanisms of prone position training are decreased lung compression in the gravity dependant zone,homogenisation of transpulmonary pressure, improvement of ventilation/perfusion ratio, and reduction of ventilator-induced lung injury (VILI) or patient self-inflicted lung injury (P-SILI). By placing the patient in the prone position, the lungs compression due to its own weight is reduced via a gravitational-dependent redistribution of fluids. In addition, the weight of the mediastinum is supported by the sternum, the stiffer part of the chest. At the same time, the diaphragm is displaced caudally, decreasing compression of the posterior-caudal lung parenchyma. Finally, in a triangular-shaped lung, more parenchyma is included in the dorsal half than in the ventral one resulting in a more aerated lung in prone positioning.

So, the purpose of this study is to observe whether preoperative prone position training can reduce the incidence of pulmonary complications after laparoscopic colorectal cancer surgery.

This study was approved by the institutional review board of the First Affiliated Hospital of Chongqing Medical University. The protocol design is in accordance with Consolidated Standards of Reporting Trials (CONSORT) statement. All potentially eligible participants will be asked to give written informed consent before they are enrolled in this study. This study is a prospective, randomized, controlled clinical trial guided by the standard of good clinical practice (GCP), and eligible participants are divided into two groups: group PPT and group C, and primary assess the incidence of pulmonary complications after laparoscopic colorectal cancer surgery.

Being tested
Prone Position Training, control group
Keywords
pulmonary complications, prone position , colorectal surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prone Position TrainingBehavioural

    All patients were admitted to our hospital at least 3 days before surgery. Patients in the intervention group (PPT group) received the prone position training daily in the hospital, three times a day, and about 1 hours every times, for at least 3 days before surgery. On the day of admission to the hospital, the patients in the PPT group were instructed to perform prone position training by nurses who were previously trained by prone position training.

  • control groupBehavioural

    Patients in the control group (C group) received standard perioperative care without any prone position training.

Study groups in NCT06001411
Study groupRoleWhat they receive
Prone Position Training group (PPT group)ExperimentalAll patients were admitted to our hospital at least 3 days before surgery. Patients in the intervention group (PPT group) received the prone position training daily in the hospital, three times a day, and about 1 hours every times, for at least 3 days before surgery. On the day of admission to the hospital, the patients in the PPT group were instructed to perform prone position training by nurses who were previously trained by prone position training.
Receives: Behavioral: Prone Position Training
Control group (C group)Placebo comparatorPatients in the control group (C group) received standard perioperative care without any prone position training.
Receives: Behavioral: control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of postoperative pulmonary complications(PPCs)

    The PPCs included pneumonia, atelectasis, pleural effusion, respiratory failure, and unplanned intubations

    Measured: 7 day after surgery

Secondary outcomes (5)
  1. arterial partial pressure of oxygen (PaO2)

    Based on the blood gas analysis

    Measured: preoperatively prior to starting prone position training, entering the operating room, the first day after surgery, the second day after surgery, and the third day after surgery

  2. extubation time

    extubation time in postanesthesia care unit (PACU)

    Measured: Day of surgery

  3. Peak airway pressure

    Airway pressure

    Measured: Intraoperative

  4. arterial partial pressure of carbon dioxide (PaCO2)

    Based on the blood gas analysis

    Measured: preoperatively prior to starting prone position training, entering the operating room, the first day after surgery, the second day after surgery, and the third day after surgery

  5. oxygenation index (OI)

    Based on the blood gas analysis

    Measured: preoperatively prior to starting prone position training, entering the operating room, the first day after surgery, the second day after surgery, and the third day after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2023
  2. Study start21 Aug 2023 (estimated)
  3. Primary completion30 Aug 2024 (estimated)
  4. Study completion6 Sep 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06001411
Sponsor's protocol ID
CQMUAZD2023
Status last verified
Aug 2023
First submitted
6 Aug 2023
Last updated
21 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Prone Position Training in people with Pulmonary Complication, run by Min Su 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 2 inclusion and 12 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 21 Aug 2023. 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. Some participants in this study may receive a placebo. 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?

Contact Dong Zhang, Master (+86-023-89011069, 848138113@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of postoperative pulmonary complications(PPCs) (time frame: 7 day after surgery). 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 21 Aug 2023.

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