Mechanical Ventilation Pressure HighNCT06256029
Recruitment Maneuver in General Anesthesia for Laparoscopic Cholecystectomy
A study testing Recruitment maneuver in people with Mechanical Ventilation Pressure High, run by University of Novi Sad at 1 site in Serbia.
Trial summary
This is a prospective non-randomized clinical trial evaluating the effect of the recruitment maneuver on static compliance in patients undergoing general anesthesia for laparoscopic cholecystectomy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Pressure High
- What is being tested?
- Recruitment maneuver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Feb 2023to 1 Sep 2025
- 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
- patients over 18 years of age
- ASA score ≤ 3 (American Society of Anesthesiologists Physical Status)
- scheduled for laparoscopic cholecystectomy
Who cannot join
- patients under the age of 18
- pregnant women
- ASA status ˃ 3,
- BMI < 18.5, and ≥ 35 kg/m2
- previous open abdominal surgery
- previous lung surgery
Show all 11Show fewer
- obstructive and restrictive lung diseases
- neuromuscular diseases
- hemodynamic instability during recruitment maneuver (drop in systolic blood pressure by more than 20% compared to basal values or systolic blood pressure < 90 mmHg)
- bradycardia (drop in heart rate by more than 20% or frequency < 50/min)
- decrease in saturation (SpO2 ≤ 92% for more than 1 minute) during the recruitment maneuver
Trial locations and contacts
1 site in 1 country.
Serbia1 site, 1 recruiting
- Recruiting
Clinical center of Vojvodina
Novi Sad, 21000
Nada Andjelic, MD, PhD, +381214843484, nada.andjelic@mf.uns.ac.rs
About this study
Official title: The Effect of Recruitment Maneuver on Static Compliance in Patients Undergoing General Anesthesia for Laparoscopic Cholecystectomy
This is a prospective non-randomized clinical trial evaluating the effect of the recruitment maneuver on static compliance in patients undergoing general anesthesia for laparoscopic cholecystectomy
Read the detailed description
The study will be performed in patients who are scheduled for laparoscopic cholecystectomy. They will be divided into two groups. Group I will consist of non-obese patients (Body Mass Index - BMI from 18.5 to 24.9 kg/m²), while group II will consist of patients with increased body mass (pre-obese and obese class I with BMI from 25 to 34.9 kg/m²).
The recruitment maneuver will be performed by increasing the current peak pressure (Ppeak) by 5 cm H2O, changing the inspiratory/expiratory ratio from 1:2 to 1:1, with PEEP values of 5 and 7 cm H2O. The respiratory rate during the recruitment maneuver will be 10 breaths per minute, and the recruitment maneuver will last 30 seconds (5 breaths). In both groups of patients, the recruitment maneuver will be performed 3 times: the first time immediately after the formation of the pneumoperitoneum and the positioning of the patient in the reverse Trendelenburg position with a PEEP of 5 cm H2O, the second time with a PEEP of 7 cm H2O, during the duration of the operation. The third recruitment maneuver will be performed with a PEEP of 7 cm H2O at the end of the operative procedure, and immediately before the patient wakes up. After each increase, PEEP will be maintained at higher pressure values with a peak value of 7 cm H2O.
Parameters of respiratory mechanics and vital parameters will be monitored during multiple stages of the laparoscopic cholecystectomy, as well as after the recruitment maneuver: (T1) after induction of anesthesia, and before the formation of pneumoperitoneum; (T2) after the formation of pneumoperitoneum and positioning of the patient in reverse Trendelenburg position; (T3) after recruitment maneuver with PEEP values of 5 cm H2O; (T4) after recruitment maneuver with PEEP values of 7 cm H2O; (T5) after deflation; (T6) immediately before awakening with recruitment maneuver and PEEP values of 7 cm H2O. All measurements will be made in VCV mode of mechanical ventilation, and recruitment maneuver will be performed in pressure control ventilation (PCV) mode of mechanical lung ventilation.
The parameters of the respiratory system mechanics will include: Ppeak , Pplat (Plateau pressure), Cdin (Dynamic Compliance), Cstat (Static Compliance) and DP (Driving pressure). The measurements will be taken in dynamic conditions (Ppeak and Cdin) and by using the maneuver of extending the inspiratory pause to 40% of the length of inspiration, in static conditions, Pplat and Cstat values will be obtained. DP will be calculated according to the formula DP = Pplat - PEEP.
From the hemodynamic measurements, changes in mean arterial pressure (MAP) and heart rate (HR) in the mentioned 6 time points T1 - T6 will be monitored. Arterial blood gas analyzes will be sampled 2 times during the surgical procedure, before the first recruitment maneuver and after the second recruitment maneuver.
- Conditions
- Mechanical Ventilation Pressure High
- Being tested
- Recruitment maneuver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recruitment maneuverProcedure or surgery
The recruitment maneuver will be performed by increasing the current peak pressure (Ppeak) by 5 cm H2O, changing the inspiratory/expiratory ratio from 1:2 to 1:1, with PEEP values of 5 and 7 cm H2O. The respiratory rate during the recruitment maneuver will be 10 breaths per minute, and the recruitment maneuver will last 30 seconds (5 breaths). The recruitment maneuver will be performed 3 times: the first time immediately after the formation of the pneumoperitoneum and the positioning of the patient in the reverse Trendelenburg position with a PEEP of 5 cm H2O, the second time with a PEEP of 7 cm H2O, during the duration of the operation. The third recruitment maneuver will be performed with a PEEP of 7 cm H2O at the end of the operative procedure, and immediately before the patient wakes up. After each increase, PEEP will be maintained at higher pressure values with a peak value of 7 cm H2O.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | All participants will undergo the recruitment maneuver. The patients will be divided into non-obese patients (BMI 18.5-24.9 kg/m²) and patients with increased body mass (BMI 25-34.9 kg/m²). Receives: Procedure: Recruitment maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static compliance
Cstat = VT / (Pplat - PEEP)
Measured: 3 hours
Secondary outcomes (2)
Mean arterial pressure
MAP = (SBP + 2*DBP) / 3
Measured: 3 hours
Arterial blood oxygen level
Partial pressure of oxygen in arterial blood gas analysis
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start1 Feb 2023
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation Pressure HighStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Novi Sad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mihaela Preveden, University of Novi Sad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256029
- Sponsor's protocol ID
- 00-39/2023
- Status last verified
- Feb 2024
- First submitted
- 4 Feb 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Recruitment Maneuver on Static Compliance in Patients Undergoing General Anesthesia for Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06256029
- Acronym / sponsor ID
- 00-39/2023
- Conditions
- Mechanical Ventilation Pressure High
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Novi SadUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 13 Feb 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.
This is a prospective non-randomized clinical trial evaluating the effect of the recruitment maneuver on static compliance in patients undergoing general anesthesia for laparoscopic cholecystectomy
Detailed description
The study will be performed in patients who are scheduled for laparoscopic cholecystectomy. They will be divided into two groups. Group I will consist of non-obese patients (Body Mass Index - BMI from 18.5 to 24.9 kg/m²), while group II will consist of patients with increased body mass (pre-obese and obese class I with BMI from 25 to 34.9 kg/m²).
The recruitment maneuver will be performed by increasing the current peak pressure (Ppeak) by 5 cm H2O, changing the inspiratory/expiratory ratio from 1:2 to 1:1, with PEEP values of 5 and 7 cm H2O. The respiratory rate during the recruitment maneuver will be 10 breaths per minute, and the recruitment maneuver will last 30 seconds (5 breaths). In both groups of patients, the recruitment maneuver will be performed 3 times: the first time immediately after the formation of the pneumoperitoneum and the positioning of the patient in the reverse Trendelenburg position with a PEEP of 5 cm H2O, the second time with a PEEP of 7 cm H2O, during the duration of the operation. The third recruitment maneuver will be performed with a PEEP of 7 cm H2O at the end of the operative procedure, and immediately before the patient wakes up. After each increase, PEEP will be maintained at higher pressure values with a peak value of 7 cm H2O.
Parameters of respiratory mechanics and vital parameters will be monitored during multiple stages of the laparoscopic cholecystectomy, as well as after the recruitment maneuver: (T1) after induction of anesthesia, and before the formation of pneumoperitoneum; (T2) after the formation of pneumoperitoneum and positioning of the patient in reverse Trendelenburg position; (T3) after recruitment maneuver with PEEP values of 5 cm H2O; (T4) after recruitment maneuver with PEEP values of 7 cm H2O; (T5) after deflation; (T6) immediately before awakening with recruitment maneuver and PEEP values of 7 cm H2O. All measurements will be made in VCV mode of mechanical ventilation, and recruitment maneuver will be performed in pressure control ventilation (PCV) mode of mechanical lung ventilation.
The parameters of the respiratory system mechanics will include: Ppeak , Pplat (Plateau pressure), Cdin (Dynamic Compliance), Cstat (Static Compliance) and DP (Driving pressure). The measurements will be taken in dynamic conditions (Ppeak and Cdin) and by using the maneuver of extending the inspiratory pause to 40% of the length of inspiration, in static conditions, Pplat and Cstat values will be obtained. DP will be calculated according to the formula DP = Pplat - PEEP.
From the hemodynamic measurements, changes in mean arterial pressure (MAP) and heart rate (HR) in the mentioned 6 time points T1 - T6 will be monitored. Arterial blood gas analyzes will be sampled 2 times during the surgical procedure, before the first recruitment maneuver and after the second recruitment maneuver.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Recruitment maneuverAll participants will undergo the recruitment maneuver. The patients will be divided into non-obese patients (BMI 18.5-24.9 kg/m²) and patients with increased body mass (BMI 25-34.9 kg/m²). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients over 18 years of age
- ASA score ≤ 3 (American Society of Anesthesiologists Physical Status)
- scheduled for laparoscopic cholecystectomy
Key exclusion criteria (11 listed)
- patients under the age of 18
- pregnant women
- ASA status ˃ 3,
- BMI < 18.5, and ≥ 35 kg/m2
- previous open abdominal 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 |
|---|---|---|
| Recruitment maneuverThe recruitment maneuver will be performed by increasing the current peak pressure (Ppeak) by 5 cm H2O, changing the inspiratory/expiratory ratio from 1:2 to 1:1, with PEEP values of 5 and 7 cm H2O. The respiratory rate during the recruitment maneuver will be 10 breaths per minute, and the recruitment maneuver will last 30 seconds (5 breaths). The recruitment maneuver will be performed 3 times: the first time immediately after the formation of the pneumoperitoneum and the positioning of the patient in the reverse Trendelenburg position with a PEEP of 5 cm H2O, the second time with a PEEP of 7 cm H2O, during the duration of the operation. The third recruitment maneuver will be performed with a PEEP of 7 cm H2O at the end of the operative procedure, and immediately before the patient wakes up. After each increase, PEEP will be maintained at higher pressure values with a peak value of 7 cm H2O. | Procedure or surgery | Experimental group |
Primary outcome
Static compliance
Time frame: 3 hours
Cstat = VT / (Pplat - PEEP)
2 secondary outcomes
Mean arterial pressure
Time frame: 3 hours
Arterial blood oxygen level
Time frame: 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recruitment maneuver in people with Mechanical Ventilation Pressure High, run by University of Novi Sad at 1 site in Serbia.
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 11 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 13 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 Serbia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nada Andjelic, MD, PhD (+381214843484, nada.andjelic@mf.uns.ac.rs), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static compliance (time frame: 3 hours). 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 13 Feb 2024.