HypercapniaNCT05793437
Effects of Permissive Hypercapnia on Concentration of Postoperative Plasma Neurofilament Light
A study testing permissive hypercapnia and normocapnia in people with Hypercapnia, run by Affiliated Hospital of Jiaxing University at 1 site in China.
Trial summary
The aim of this study is to conduct a prospective, single-center randomized controlled study to investigate the changes of plasma NFL concentration in patients undergoing laparoscopic surgery with mild hypercapnia, and further explore its impact on the central nervous system. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hypercapnia
- What is being tested?
- permissive hypercapnia and normocapnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 28 Jan 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age over 60 years
- duration of pneumoperitoneum greater than 60 minutes
- American Society of Anesthesiology (ASA) status Ⅱ-Ⅲ
- undergoing laparoscopic surgery under general anesthesia with endotracheal intubation
Who cannot join
- history of mental or neurological disorders
- preoperative use of antipsychotic drugs
- American Society of Anesthesiology (ASA) status Ⅳ
- severe abnormalities in heart, lung, liver, kidney, and coagulation function
- Intracranial space-occupying lesions or major cerebrovascular diseases (such as carotid atherosclerosis and cerebral aneurysm)
- Severe hypertension or hypotension
- Severe metabolic acidosis or hypercapnic respiratory failure before surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Permissive Hypercapnia on Concentration of Postoperative Plasma Neurofilament Light in Elderly Patients Undergoing Laparoscopic Surgery:A Prospective, Randomized Controlled Study
The aim of this study is to conduct a prospective, single-center randomized controlled study to investigate the changes of plasma NFL concentration in patients undergoing laparoscopic surgery with mild hypercapnia, and further explore its impact on the central nervous system.
Read the detailed description
Plasma NFL concentrations were measured preoperatively and 1 day postoperatively.
Secondary endpoints:CAM (Confusion Assessment Method) is conducted to check the subjects' baseline cognitive function preoperative day and 1 day postoperatively to assess whether delirium occurs.
- Conditions
- Hypercapnia
- Being tested
- permissive hypercapnia, normocapnia
- Keywords
- Neurofilament light, Hypercapnia
- Medical subject headings
- Hypercapnia, Charcot-Marie-Tooth disease, Type 1F
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
permissive hypercapniaBehavioural
Also called PaCO2:45～55mmHg
Tidal volume (6-8ml/kg) and respiratory rate is adjusted to achieve the objective values of PaCO2:45～55mmHg
normocapniaBehavioural
Also called PaCO2:35～45mmHg
Tidal volume (8-10ml/kg) and respiratory rate is adjusted to achieve the objective values of PaCO2:35～45mmHg
| Study group | Role | What they receive |
|---|---|---|
| permissive hypercapnia | Experimental | Tidal volume (6-8ml/kg) and respiratory rate is adjusted to achieve the objective values of PaCO2:45～55mmHg Receives: Behavioral: permissive hypercapnia |
| normocapnia | Active comparator | Tidal volume (8-10ml/kg) and respiratory rate is adjusted to achieve the objective values of PaCO2:35～45mmHg Receives: Behavioral: normocapnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in plasma Neurofilament Light levels
Comparison of changes in plasma Neurofilament Light levels pre and postoperative in patients exposed and not exposed to hypercapnia.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start1 Apr 2023
- Primary completion28 Jan 2024
- Study completion28 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercapniaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Jiaxing University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing-he Zhou, Affiliated Hospital of Jiaxing University
- Investigators
- Qinghe Zhou, Principal investigator, Affiliated Hospital of Jiaxing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793437
- Sponsor's protocol ID
- 2023-KY-050
- Status last verified
- Jan 2024
- First submitted
- 3 Mar 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Permissive Hypercapnia on Concentration of Postoperative Plasma Neurofilament Light in Elderly Patients Undergoing Laparoscopic Surgery:A Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05793437
- Acronym / sponsor ID
- 2023-KY-050
- Conditions
- Hypercapnia
- Keywords
- Neurofilament light, Hypercapnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Affiliated Hospital of Jiaxing UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 28 Jan 2024 (actual)
- Study completion
- 28 Jan 2024 (actual)
- First posted
- 31 Mar 2023 (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.
The aim of this study is to conduct a prospective, single-center randomized controlled study to investigate the changes of plasma NFL concentration in patients undergoing laparoscopic surgery with mild hypercapnia, and further explore its impact on the central nervous system.
Detailed description
Plasma NFL concentrations were measured preoperatively and 1 day postoperatively.
Secondary endpoints:CAM (Confusion Assessment Method) is conducted to check the subjects' baseline cognitive function preoperative day and 1 day postoperatively to assess whether delirium occurs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| permissive hypercapnia | Experimental | Behavioral: permissive hypercapniaTidal volume (6-8ml/kg) and respiratory rate is adjusted to achieve the objective values of PaCO2:45～55mmHg |
| normocapnia | Active comparator | Behavioral: normocapniaTidal volume (8-10ml/kg) and respiratory rate is adjusted to achieve the objective values of PaCO2:35～45mmHg |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age over 60 years
- duration of pneumoperitoneum greater than 60 minutes
- American Society of Anesthesiology (ASA) status Ⅱ-Ⅲ
- undergoing laparoscopic surgery under general anesthesia with endotracheal intubation
Key exclusion criteria (7 listed)
- history of mental or neurological disorders
- preoperative use of antipsychotic drugs
- American Society of Anesthesiology (ASA) status Ⅳ
- severe abnormalities in heart, lung, liver, kidney, and coagulation function
- Intracranial space-occupying lesions or major cerebrovascular diseases (such as carotid atherosclerosis and cerebral aneurysm)
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 |
|---|---|---|
| permissive hypercapniaAlso: PaCO2:45～55mmHgTidal volume (6-8ml/kg) and respiratory rate is adjusted to achieve the objective values of PaCO2:45～55mmHg | Behavioural | permissive hypercapnia |
| normocapniaAlso: PaCO2:35～45mmHgTidal volume (8-10ml/kg) and respiratory rate is adjusted to achieve the objective values of PaCO2:35～45mmHg | Behavioural | normocapnia |
Primary outcome
Changes in plasma Neurofilament Light levels
Time frame: 1 week
Comparison of changes in plasma Neurofilament Light levels pre and postoperative in patients exposed and not exposed to hypercapnia.
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 1 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Qinghe Zhou principal investigator
Affiliated Hospital of Jiaxing University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing permissive hypercapnia and normocapnia in people with Hypercapnia, run by Affiliated Hospital of Jiaxing 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 4 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 1 Feb 2024. 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?
Changes in plasma Neurofilament Light levels (time frame: 1 week). 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 1 Feb 2024.