AtelectasisNCT06203665
Restoration of Pulmonary Compliance After Laparoscopic Gynaecologic Surgery Using a Recruitment Maneuver
A study testing Recruitment Maneuver in people with Atelectasis and Compliance, Patient, run by Panagiota Griva at 1 site in Greece.
Trial summary
To investigate the hypothesis that an alveolar recruitment maneuver after the release of pneumoperitoneum would restore the lung compliance to the baseline values after a laparoscopic gynaecologic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Atelectasis, Compliance, Patient
- What is being tested?
- Recruitment Maneuver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteGreece
- Study dates
- 7 Jun 2023to 5 Mar 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 years old patients
- A gynaecologic laparoscopic surgery would be performed
- Duration of the surgery over 90 minutes
Who cannot join
- Chronic Obstructive Lung Disease with FEV1 < 60 of predicted value
- Lung Emphysema
- BMI > 30
- Hemodynamic instability during the operation
- Acute cor pulmonle
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the hypothesis that an alveolar recruitment maneuver after the release of pneumoperitoneum would restore the lung compliance to the baseline values after a laparoscopic gynaecologic surgery.
Read the detailed description
In recent years, laparoscopic surgery is a common minimal invasive technique which ensures the avoidance of prolong hospital stay, long duration surgery, postoperative pain, operation scars. However, laparoscopic surgery has a negative impact on respiratory mechanics because of the pneumoperitoneum, the changes in position and the appliance of positive pressure ventilation. The increase in abdominal pressure as a result of carbon dioxide insufflation and the typical head-down body position have been shown to impair respiratory function. Application of a pneumoperitoneum-induced elevation of intraabdominal pressure elevates the diaphragm and results in a compression of the dependent ventral lung regions. As a consequence, the amount of atelectasis is increased. The insufflation of CO2 reduced respiratory system compliance, and increased peak inspiratory and mean airway pressures. Additionally, changes to the lithotomy and Trendelenburg position during gynaecologic surgery reduce lung compliance by altering the location of intestinal contents and diaphragm. Especially the Trendelenburg position potentiates the effects of abdominal pressure via gravity and relaxation of the diaphragm; thereby, increasing the airway pressure and reducing the functional residual capacity, which results in further changes in the respiratory system. Therefore, we evaluated the effect of an alveolar recruitment maneuver during gynaecologic laparoscopic surgery by determining the changes in lung compliance.
Design: Prospective study. Setting: Operating room of a hospital. Patients: 31 ASA physical status I and II patients scheduled to undergo gynaecologic laparoscopic surgery in the dorsal lithotomy position.
Interventions: The surgery would be performed under general anaesthesia according to the common practice using protective lung ventilation ( Vt= 6 ml /Kg ideal body weight , RR to maintain end-expiratory CO2 35-45 cmH2O and PEEP= 6- 8 cm H20). An incremental and decremental positive end-expiratory pressure alveolar recruitment maneuver would be performed after release of pneumoperitoneum.
Measurements: Respiratory mechanics including dynamic compliance were measured continuously. Respiratory measures were recorded together with arterial blood gases after induction (T1), with the patient placed in the dorsal lithotomy position (T2), 10 and 90 minutes after CO2 insufflation (T3 and T4), immediately after desufflation in the lithotomy and supine positions (T5 and T6), and 10 minutes after a pulmonary recruitment maneuver at the conclusion of surgery (T7).
Inclusion criteria:
- >18 years old patients
- A gynaecologic laparoscopic surgery would be performed
- Duration of the surgery over 90 minutes
Exclusion criteria:
- Chronic Obstructive Lung Disease with FEV1 < 60 of predicted value
- Lung Emphysema
- BMI > 30
- Hemodynamic instability during the operation
- Acute cor pulmonale
- Conditions
- Atelectasis, Compliance, Patient
- Being tested
- Recruitment Maneuver
- Medical subject headings
- Pulmonary Atelectasis, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recruitment ManeuverDiagnostic test
The surgery would be performed under general anaesthesia according to the common practice using protective lung ventilation ( Vt= 6 ml /Kg ideal body weight , RR to maintain end-expiratory CO2 35-45 cmH2O and PEEP= 6- 8 cm H20). An incremental and decremental positive end-expiratory pressure alveolar recruitment maneuver would be performed after release of pneumoperitoneum.
| Study group | Role | What they receive |
|---|---|---|
| Patients enrolled in the protocol | Experimental | An alveolar recruitment nameuver will be performed after the release of pneumoperitoneum Receives: Diagnostic Test: Recruitment Maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta (Δ) Compliance (T1 -T7)
The compliance difference between T1 and T7, where T1 denotes the time of induction to anaesthesia and T7 is the release of pneumoperitoneum time.
Measured: intraoperative, after anesthesia induction and after the release of pneumoperitoneum
Delta (Δ) Compliance (T1 -T8)
The compliance difference between T1 and T8, where T8 is the time of the recruitment maneuver.
Measured: intraoperative, after anesthesia induction and after the recruitment maneuver
Delta (Δ) Compliance (T7 -T8)
The different compliance between T7 and T8
Measured: intraoperative, after the release of pneumoperitoneum and after the recruitment maneuver
Secondary outcomes (4)
Compliance (in mL/cmH2O)
Compliance of the lungs measured at the following time frames: after anesthesia induction (T1), after dorsal lithotomy position (T2), after Trendelenburg position (T3), 10 and 90 minutes after CO2 insufflation (T4, T5 respectively), after removal of Trendelenburg position (T6), after desufflation (T7), 10 minutes after an alveolar recruitment maneuver (T8).
Measured: intraoperative (T1-T8)
Pplateau (in cmH2O)
end-inspiratory airway pressure measured at the following time frames: after anesthesia induction (T1), after dorsal lithotomy position (T2), after Trendelenburg position (T3), 10 and 90 minutes after CO2 insufflation (T4, T5 respectively), after removal of Trendelenburg position (T6), after desufflation (T7), 10 minutes after an alveolar recruitment maneuver (T8).
Measured: intraoperative (T1-T8)
MAP (in mmHg)
Mean Arterial Pressure measured at the following time frames: after anesthesia induction (T1), after dorsal lithotomy position (T2), after Trendelenburg position (T3), 10 and 90 minutes after CO2 insufflation (T4, T5 respectively), after removal of Trendelenburg position (T6), after desufflation (T7), 10 minutes after an alveolar recruitment maneuver (T8).
Measured: intraoperative (T1-T8)
Intraoperative administration of vasoactive agents
The dose of the vasoactive agents administrated to maintain a Mean Arterial Pressure > 65mmHg during the alveolar recruitment maneuver
Measured: intraoperative, after alveolar recruitment maneuver
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start7 Jun 2023
- Primary completion1 Feb 2024
- Study completion5 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtelectasisStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panagiota Griva
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Panagiota Griva, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203665
- Sponsor's protocol ID
- 275/27-04-2023
- Status last verified
- Mar 2024
- First submitted
- 6 Dec 2023
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- 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 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of Pulmonary Compliance After Laparoscopic Gynaecologic Surgery Using a Recruitment Maneuver
- ClinicalTrials.gov ID
- NCT06203665
- Acronym / sponsor ID
- 275/27-04-2023
- Conditions
- Atelectasis, Compliance, Patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Panagiota GrivaUniversity, hospital or other
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 12 Jan 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.
To investigate the hypothesis that an alveolar recruitment maneuver after the release of pneumoperitoneum would restore the lung compliance to the baseline values after a laparoscopic gynaecologic surgery.
Detailed description
In recent years, laparoscopic surgery is a common minimal invasive technique which ensures the avoidance of prolong hospital stay, long duration surgery, postoperative pain, operation scars. However, laparoscopic surgery has a negative impact on respiratory mechanics because of the pneumoperitoneum, the changes in position and the appliance of positive pressure ventilation. The increase in abdominal pressure as a result of carbon dioxide insufflation and the typical head-down body position have been shown to impair respiratory function. Application of a pneumoperitoneum-induced elevation of intraabdominal pressure elevates the diaphragm and results in a compression of the dependent ventral lung regions. As a consequence, the amount of atelectasis is increased. The insufflation of CO2 reduced respiratory system compliance, and increased peak inspiratory and mean airway pressures. Additionally, changes to the lithotomy and Trendelenburg position during gynaecologic surgery reduce lung compliance by altering the location of intestinal contents and diaphragm. Especially the Trendelenburg position potentiates the effects of abdominal pressure via gravity and relaxation of the diaphragm; thereby, increasing the airway pressure and reducing the functional residual capacity, which results in further changes in the respiratory system. Therefore, we evaluated the effect of an alveolar recruitment maneuver during gynaecologic laparoscopic surgery by determining the changes in lung compliance.
Design: Prospective study. Setting: Operating room of a hospital. Patients: 31 ASA physical status I and II patients scheduled to undergo gynaecologic laparoscopic surgery in the dorsal lithotomy position.
Interventions: The surgery would be performed under general anaesthesia according to the common practice using protective lung ventilation ( Vt= 6 ml /Kg ideal body weight , RR to maintain end-expiratory CO2 35-45 cmH2O and PEEP= 6- 8 cm H20). An incremental and decremental positive end-expiratory pressure alveolar recruitment maneuver would be performed after release of pneumoperitoneum.
Measurements: Respiratory mechanics including dynamic compliance were measured continuously. Respiratory measures were recorded together with arterial blood gases after induction (T1), with the patient placed in the dorsal lithotomy position (T2), 10 and 90 minutes after CO2 insufflation (T3 and T4), immediately after desufflation in the lithotomy and supine positions (T5 and T6), and 10 minutes after a pulmonary recruitment maneuver at the conclusion of surgery (T7).
Inclusion criteria:
- >18 years old patients
- A gynaecologic laparoscopic surgery would be performed
- Duration of the surgery over 90 minutes
Exclusion criteria:
- Chronic Obstructive Lung Disease with FEV1 < 60 of predicted value
- Lung Emphysema
- BMI > 30
- Hemodynamic instability during the operation
- Acute cor pulmonale
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients enrolled in the protocol | Experimental | Diagnostic Test: Recruitment ManeuverAn alveolar recruitment nameuver will be performed after the release of pneumoperitoneum |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18 years old patients
- A gynaecologic laparoscopic surgery would be performed
- Duration of the surgery over 90 minutes
Key exclusion criteria (5 listed)
- Chronic Obstructive Lung Disease with FEV1 < 60 of predicted value
- Lung Emphysema
- BMI > 30
- Hemodynamic instability during the operation
- Acute cor pulmonle
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 surgery would be performed under general anaesthesia according to the common practice using protective lung ventilation ( Vt= 6 ml /Kg ideal body weight , RR to maintain end-expiratory CO2 35-45 cmH2O and PEEP= 6- 8 cm H20). An incremental and decremental positive end-expiratory pressure alveolar recruitment maneuver would be performed after release of pneumoperitoneum. | Diagnostic test | Patients enrolled in the protocol |
Primary outcome
Delta (Δ) Compliance (T1 -T7)
Time frame: intraoperative, after anesthesia induction and after the release of pneumoperitoneum
The compliance difference between T1 and T7, where T1 denotes the time of induction to anaesthesia and T7 is the release of pneumoperitoneum time.
Delta (Δ) Compliance (T1 -T8)
Time frame: intraoperative, after anesthesia induction and after the recruitment maneuver
The compliance difference between T1 and T8, where T8 is the time of the recruitment maneuver.
Delta (Δ) Compliance (T7 -T8)
Time frame: intraoperative, after the release of pneumoperitoneum and after the recruitment maneuver
The different compliance between T7 and T8
4 secondary outcomes
Compliance (in mL/cmH2O)
Time frame: intraoperative (T1-T8)
Pplateau (in cmH2O)
Time frame: intraoperative (T1-T8)
MAP (in mmHg)
Time frame: intraoperative (T1-T8)
Intraoperative administration of vasoactive agents
Time frame: intraoperative, after alveolar recruitment maneuver
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 20 Mar 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.
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?
A study testing Recruitment Maneuver in people with Atelectasis and Compliance, Patient, run by Panagiota Griva at 1 site in Greece.
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 5 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 20 Mar 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 Greece. 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?
Delta (Δ) Compliance (T1 -T7) (time frame: intraoperative, after anesthesia induction and after the release of pneumoperitoneum). The study lists 3 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 20 Mar 2024.