TrendelenburgNCT06044402
Different Tidal Volume on Oxygenation, Respiratory Mechanics, and Pulmonary Complications in Older Patients Undergoing Trendelenburg Pneumoperitoneum Surgery
A study testing group L (Vt 6 ml/kg) and group I (Vt 8 ml/kg) in people with Trendelenburg and Neumoperitoneum, run by dong zhang.
Trial summary
The investigators want to assess the effect of intraoperative low tidal volume vs intermediate tidal volume on respiratory mechanics, oxygenation and pulmonary complications in older patients undergoing Trendelenburg pneumoperitoneum surgery. Read more about this study
- Who is it for?
- Ages 66 years and older
- Conditions the study is for
- Trendelenburg, Neumoperitoneum, Oxygenation
- What is being tested?
- group L (Vt 6 ml/kg) and group I (Vt 8 ml/kg)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 8 Oct 2023to 30 Dec 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 66 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I-III class;
- Colorectal cancer patients;
- Elective laparoscopic colorectal surgery;
- expected duration of surgery greater than 2 hours.
Who cannot join
- serious complications associated with other systems;
- severe cardiac insufficiency;
- renal failure;
- body mass index (BMI) greater than 30 kg/m2 or less than 18 kg/m2;
- the use of low tidal volume and consequent hypercapnia can induce harm;
- refusal to participate in the study.
About this study
Official title: Effect of Intraoperative Low Tidal Volume vs Intermediate Tidal Volume on Oxygenation, Respiratory Mechanics, and Pulmonary Complications in Older Patients Undergoing Trendelenburg Pneumoperitoneum Surgery: A Randomized Clinical Trial
The investigators want to assess the effect of intraoperative low tidal volume vs intermediate tidal volume on respiratory mechanics, oxygenation and pulmonary complications in older patients undergoing Trendelenburg pneumoperitoneum surgery.
- Conditions
- Trendelenburg, Neumoperitoneum, Oxygenation, Respiratory, Pulmonary
- Being tested
- group L (Vt 6 ml/kg), group I (Vt 8 ml/kg)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group L (Vt 6 ml/kg)Other
low tidal volume ventilation (tidal volume was set to 6 ml/kg)
group I (Vt 8 ml/kg)Other
intermediate tidal volume ventilation (tidal volume was set to 8 ml/kg)
| Study group | Role | What they receive |
|---|---|---|
| group L | Placebo comparator | Ventilation was subsequently changed to individualized positive end-expiratory pressure and recruitment maneuvers during trendelenburg pneumoperitoneum, and the tidal volume was set to 6 ml/kg. Receives: Other: group L (Vt 6 ml/kg) |
| group I | Experimental | Ventilation was subsequently changed to individualized positive end-expiratory pressure and recruitment maneuvers during trendelenburg pneumoperitoneum, and the tidal volume was set to 8 ml/kg. Receives: Other: group I (Vt 8 ml/kg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2/FiO2
the outcome in mmHg
Measured: the lowest value at one hour after extubation, day-1 to day-3
hypoxemia
the outcome in fraction
Measured: From date of patient admission until the date of discharge, assessed up to 7 days
pneumonia
the outcome in fraction
Measured: From date of patient admission until the date of discharge, assessed up to 7 days
bronchospasm
the outcome in fraction
Measured: From date of patient admission until the date of discharge, assessed up to 7 days
atelectasis
the outcome in fraction
Measured: From date of patient admission until the date of discharge, assessed up to 7 days
pulmonary congestion
the outcome in fraction
Measured: From date of patient admission until the date of discharge, assessed up to 7 days
respiratory failure
the outcome in fraction
Measured: From date of patient admission until the date of discharge, assessed up to 7 days
pleural effusion
the outcome in fraction
Measured: From date of patient admission until the date of discharge, assessed up to 7 days
pneumothorax
the outcome in fraction
Measured: From date of patient admission until the date of discharge, assessed up to 7 days
unplanned requirement for postoperative invasive or noninvasive ventilation
the outcome in fraction
Measured: From date of patient admission until the date of discharge, assessed up to 7 days
Secondary outcomes (29)
Tidal volume
the outcome in milliliter
Measured: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
respiratory rate
the outcome in times/minute (frequency)
Measured: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
dead space fraction
the outcome in fraction
Measured: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
A-aDO2
the outcome in mmHg
Measured: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
intrapulmonary shunt
the outcome in fraction
Measured: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
peak airway pressure
the outcome in cmH2O
Measured: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
plateau airway pressure
the outcome in cmH2O
Measured: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
mean airway pressure
the outcome in cmH2O
Measured: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
dynamic compliance
the outcome in milliliter/cmH2O
Measured: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
arterial blood pH
the outcome in number
Measured: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
arterial blood PO2
the outcome in mmHg
Measured: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
arterial blood PCO2
the outcome in mmHg
Measured: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
arterial blood Hb
the outcome in g/dl
Measured: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
arterial blood Hct
the outcome in fraction
Measured: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
arterial blood SO2
the outcome in fraction
Measured: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
arterial blood K
the outcome in mmol/L
Measured: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
arterial blood Na
the outcome in mmol/L
Measured: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
arterial blood Ca
the outcome in mmol/L
Measured: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
arterial blood Cl
the outcome in mmol/L
Measured: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
arterial blood Glu
the outcome in mmol/L
Measured: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
arterial blood Lac
the outcome in mmol/L
Measured: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
arterial blood tBil
the outcome in umol/L
Measured: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
arterial blood SBE
the outcome in mmol/L
Measured: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
arterial blood ABE
the outcome in mmol/L
Measured: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
PaO2/FiO2
the outcome in mmHg
Measured: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
unplanned intensive care unit admission
the outcome in fraction
Measured: From date of finishing surgery until the date of patient discharge, assessed up to 7 days
intensive care unit length of stay
the outcome in days
Measured: From date of finishing surgery until the date of patient discharge, assessed up to 7 days
postoperative mortality
the outcome in fraction
Measured: From date of finishing surgery until the date of patient discharge, assessed up to 7 days
hospital length of stay
the outcome in days
Measured: From date of patient admission until the date of discharge, assessed up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start8 Oct 2023 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrendelenburgStudies 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
- Model description
- A randomized, double-blind, controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- dong zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, dong zhang, Gansu Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044402
- Sponsor's protocol ID
- GanSu Province Hospital
- Status last verified
- Sep 2023
- First submitted
- 24 Aug 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Low Tidal Volume vs Intermediate Tidal Volume on Oxygenation, Respiratory Mechanics, and Pulmonary Complications in Older Patients Undergoing Trendelenburg Pneumoperitoneum Surgery: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06044402
- Acronym / sponsor ID
- GanSu Province Hospital
- Conditions
- Trendelenburg, Neumoperitoneum, Oxygenation, Respiratory, Pulmonary
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- dong zhangUniversity, hospital or other
- Study start
- 8 Oct 2023 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 21 Sep 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 investigators want to assess the effect of intraoperative low tidal volume vs intermediate tidal volume on respiratory mechanics, oxygenation and pulmonary complications in older patients undergoing Trendelenburg pneumoperitoneum surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, double-blind, controlled trial
| Arm | Type | Receives |
|---|---|---|
| group L | Placebo comparator | Other: group L (Vt 6 ml/kg)Ventilation was subsequently changed to individualized positive end-expiratory pressure and recruitment maneuvers during trendelenburg pneumoperitoneum, and the tidal volume was set to 6 ml/kg. |
| group I | Experimental | Other: group I (Vt 8 ml/kg)Ventilation was subsequently changed to individualized positive end-expiratory pressure and recruitment maneuvers during trendelenburg pneumoperitoneum, and the tidal volume was set to 8 ml/kg. |
Who may qualify
- Ages
- 66 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) physical status I-III class;
- Colorectal cancer patients;
- Elective laparoscopic colorectal surgery;
- expected duration of surgery greater than 2 hours.
Key exclusion criteria (6 listed)
- serious complications associated with other systems;
- severe cardiac insufficiency;
- renal failure;
- body mass index (BMI) greater than 30 kg/m2 or less than 18 kg/m2;
- the use of low tidal volume and consequent hypercapnia can induce harm;
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 |
|---|---|---|
| group L (Vt 6 ml/kg)low tidal volume ventilation (tidal volume was set to 6 ml/kg) | Other | group L |
| group I (Vt 8 ml/kg)intermediate tidal volume ventilation (tidal volume was set to 8 ml/kg) | Other | group I |
Primary outcome
PaO2/FiO2
Time frame: the lowest value at one hour after extubation, day-1 to day-3
the outcome in mmHg
hypoxemia
Time frame: From date of patient admission until the date of discharge, assessed up to 7 days
the outcome in fraction
pneumonia
Time frame: From date of patient admission until the date of discharge, assessed up to 7 days
the outcome in fraction
bronchospasm
Time frame: From date of patient admission until the date of discharge, assessed up to 7 days
the outcome in fraction
atelectasis
Time frame: From date of patient admission until the date of discharge, assessed up to 7 days
the outcome in fraction
pulmonary congestion
Time frame: From date of patient admission until the date of discharge, assessed up to 7 days
the outcome in fraction
respiratory failure
Time frame: From date of patient admission until the date of discharge, assessed up to 7 days
the outcome in fraction
pleural effusion
Time frame: From date of patient admission until the date of discharge, assessed up to 7 days
the outcome in fraction
pneumothorax
Time frame: From date of patient admission until the date of discharge, assessed up to 7 days
the outcome in fraction
unplanned requirement for postoperative invasive or noninvasive ventilation
Time frame: From date of patient admission until the date of discharge, assessed up to 7 days
the outcome in fraction
29 secondary outcomes
Tidal volume
Time frame: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
respiratory rate
Time frame: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
dead space fraction
Time frame: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
A-aDO2
Time frame: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
intrapulmonary shunt
Time frame: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
peak airway pressure
Time frame: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
plateau airway pressure
Time frame: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
mean airway pressure
Time frame: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
dynamic compliance
Time frame: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
arterial blood pH
Time frame: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
arterial blood PO2
Time frame: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
arterial blood PCO2
Time frame: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
arterial blood Hb
Time frame: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
arterial blood Hct
Time frame: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
arterial blood SO2
Time frame: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
arterial blood K
Time frame: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
arterial blood Na
Time frame: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
arterial blood Ca
Time frame: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
arterial blood Cl
Time frame: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
arterial blood Glu
Time frame: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
arterial blood Lac
Time frame: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
arterial blood tBil
Time frame: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
arterial blood SBE
Time frame: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
arterial blood ABE
Time frame: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
PaO2/FiO2
Time frame: before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
unplanned intensive care unit admission
Time frame: From date of finishing surgery until the date of patient discharge, assessed up to 7 days
intensive care unit length of stay
Time frame: From date of finishing surgery until the date of patient discharge, assessed up to 7 days
postoperative mortality
Time frame: From date of finishing surgery until the date of patient discharge, assessed up to 7 days
hospital length of stay
Time frame: From date of patient admission until the date of discharge, assessed up to 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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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?
A study testing group L (Vt 6 ml/kg) and group I (Vt 8 ml/kg) in people with Trendelenburg and Neumoperitoneum, run by dong zhang.
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 6 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 Sep 2023. 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. 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?
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?
PaO2/FiO2 (time frame: the lowest value at one hour after extubation, day-1 to day-3). The study lists 10 primary outcomes in all. 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 Sep 2023.