Decreased Lung CompliancePhase 2CSRecGHPyrNCT01826968
Alveolar Recruitment Maneuver During Cesarean Section Improves Lung Compliance
A Phase 2 study testing Alveolar Recruitment maneuver in people with Decreased Lung Compliance and Hypoxia, run by General Hospital Of Pyrgos at 1 site in Greece.
Trial summary
The investigators tested the hypothesis that alveolar recruitment maneuver during cesarean section and in women under general anesthesia improves lung compliance and gas exchange. The investigators applied recruitment maneuver and positive end expiratory pressure (PEEP) 8 cmH2O. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Decreased Lung Compliance, Hypoxia, Hypercapnia
- What is being tested?
- Alveolar Recruitment maneuver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2013to Mar 2014
- Phase
- Phase 2
- 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 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- general anesthesia,
- hemodynamically stable
Who cannot join
- intracranial hypertension,
- pulmonary hypertension,
- low blood pressure (MBP<80 mmHg),
- Heart rate > 100 beats/min,
- patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study of the Alveolar Recruitment Maneuver in Cesarean Section
The investigators tested the hypothesis that alveolar recruitment maneuver during cesarean section and in women under general anesthesia improves lung compliance and gas exchange. The investigators applied recruitment maneuver and positive end expiratory pressure (PEEP) 8 cmH2O. The maximum alveolar pressure limit (Ppeak)was 45 cmH2O during the recruitment maneuver. The primary end point of the study is the improvement of the lung compliance measured as volume difference/pressure difference (dv/dp) or ml/cmH2O
Read the detailed description
The investigators used recruitment maneuver during cesarean section and in women under general anesthesia. The primary end point of the study is the improvement of the lung compliance measured as volume difference/pressure difference (dv/dp) or ml/cmH2O after the recruitment maneuver. The investigators used 2 groups of patients. In the first group the investigators used pressure control ventilation for the recruitment maneuver. After the ventilator was switched to pressure control mode the investigators increased the inspiratory time to 50% and the inspiratory pressure above Positive End Expiratory Pressure (Ppeak) to 20 cmH2O. Then the investigators progressively increased Positive End Expiratory Pressure (PEEP) to have a peak inspiratory pressure (Ppeak) to 45 cm H2O. The whole recruitment maneuver lasts 2 minutes. After the recruitment maneuver the investigators used volume control ventilation again (with the baseline settings)and PEEP step wised decreased to 8 cmH20but. PEEP (8cmH2O) was left until the end of the operation. In the second group the investigators did not used lung recruitment maneuver at all. In both groups lung compliance was measured (dynamic and static)as dv/dp (ml/cmH2O). Measures were assessed 1 minute after delivery (but before recruitment), 3 minutes after recruitment (first group) at 10 and at 20 minutes after recruitment. The investigators also measured Ppeak (cmH2O) and Pplateau (cmH2O)inspiratory pressures , blood pressure (mmHG), beats per minute, oxygen saturation, end-tidal CO2 according to the above time frame, blood Gases before and 3 minutes after recruitment etc.
- Conditions
- Decreased Lung Compliance, Hypoxia, Hypercapnia, Atelectasis, Pneumonia
- Being tested
- Alveolar Recruitment maneuver
- Keywords
- Lung recruitment, cesarean, lung compliance, atelectasis
- Medical subject headings
- Hypoxia, Hypercapnia, Pulmonary Atelectasis, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar Recruitment maneuverProcedure or surgery
In this group and during recruitment maneuver the investigators used pressure control ventilation and increased inspiratory time to 50%. The investigators used alveolar recruitment maneuver by increasing inspiratory pressure to 20 cmH20 and progressively increasing Positive Expiratory Pressure (PEEP) up to 45 cmH2O maximal (Ppeak) inspiratory pressure. The recruitment maneuver lasted 2 minutes. After the maneuver PEEP was set to 8 cmH2O and was left until the end of the operation. After the end of the recruitment maneuver volume control ventilation was used until the end of the operation too.
| Study group | Role | What they receive |
|---|---|---|
| Recruitment Group | Experimental | The investigators used alveolar recruitment maneuver by increasing inspiratory pressure to 20 cmH20 and progressively increasing Positive Expiratory Pressure (PEEP) up to 45 cmH2O maximal (Ppeak) inspiratory pressure. The recruitment maneuver lasted 2 minutes. In this group PEEP was set to 8 cmH2O, after the recruitment maneuver, and was left until the end of the operation. Receives: Procedure: Alveolar Recruitment maneuver |
| Control Group | No intervention | We did not used alveolar recruitment maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Compliance change measured as volume difference/pressure difference (dv/dp) or ml/cmH2O is being assessed
Measured: Before recruitment, 3 minutes after recruitment, 10 minutes after recruitment and 20 minutes after recruitment
Secondary outcomes (3)
Oxygenation change is being assessed measured as PO2 (mmHg) and O2 Saturation (SPO2)
Measured: Before recruitment and 20 minutes after recruitment
Gas exchange change is being assessed measured as PCO2 (mmHg) and PH.
Measured: Before recruitment and at 20 minutes after recruitment
Pulmonary complications
Measured: up to 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Decreased Lung ComplianceStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital Of Pyrgos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diamanto Aretha, General Hospital Of Pyrgos
- Investigators
- Diamanto Aretha, MD, Principal investigator, General Hospital of Pyrgos, Sintriada, Pyrgos, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826968
- Sponsor's protocol ID
- Lung Recruitment in Cesareans
- Other IDs
- GHPyrgosRECProt
- Acronym
- CSRecGHPyr
- Status last verified
- Nov 2013
- First submitted
- 29 Mar 2013
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Valenza F, Chevallard G, Fossali T, Salice V, Pizzocri M, Gattinoni L. Management of mechanical ventilation during laparoscopic surgery. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):227-41. doi: 10.1016/j.bpa.2010.02.002.
PubMed 20608559Strang CM, Hachenberg T, Freden F, Hedenstierna G. Development of atelectasis and arterial to end-tidal PCO2-difference in a porcine model of pneumoperitoneum. Br J Anaesth. 2009 Aug;103(2):298-303. doi: 10.1093/bja/aep102. Epub 2009 May 13.
PubMed 19443420Hedenstierna G, Edmark L. The effects of anesthesia and muscle paralysis on the respiratory system. Intensive Care Med. 2005 Oct;31(10):1327-35. doi: 10.1007/s00134-005-2761-7. Epub 2005 Aug 16.
PubMed 16132894Cinnella G, Grasso S, Spadaro S, Rauseo M, Mirabella L, Salatto P, De Capraris A, Nappi L, Greco P, Dambrosio M. Effects of recruitment maneuver and positive end-expiratory pressure on respiratory mechanics and transpulmonary pressure during laparoscopic surgery. Anesthesiology. 2013 Jan;118(1):114-22. doi: 10.1097/ALN.0b013e3182746a10.
PubMed 23196259
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of the Alveolar Recruitment Maneuver in Cesarean Section
- ClinicalTrials.gov ID
- NCT01826968
- Acronym / sponsor ID
- CSRecGHPyr / Lung Recruitment in Cesareans
- Conditions
- Decreased Lung Compliance, Hypoxia, Hypercapnia, Atelectasis, Pneumonia
- Keywords
- Lung recruitment, cesarean, lung compliance, atelectasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- General Hospital Of PyrgosUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 9 Apr 2013 (estimated)
- 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 tested the hypothesis that alveolar recruitment maneuver during cesarean section and in women under general anesthesia improves lung compliance and gas exchange. The investigators applied recruitment maneuver and positive end expiratory pressure (PEEP) 8 cmH2O. The maximum alveolar pressure limit (Ppeak)was 45 cmH2O during the recruitment maneuver. The primary end point of the study is the improvement of the lung compliance measured as volume difference/pressure difference (dv/dp) or ml/cmH2O
Detailed description
The investigators used recruitment maneuver during cesarean section and in women under general anesthesia. The primary end point of the study is the improvement of the lung compliance measured as volume difference/pressure difference (dv/dp) or ml/cmH2O after the recruitment maneuver. The investigators used 2 groups of patients. In the first group the investigators used pressure control ventilation for the recruitment maneuver. After the ventilator was switched to pressure control mode the investigators increased the inspiratory time to 50% and the inspiratory pressure above Positive End Expiratory Pressure (Ppeak) to 20 cmH2O. Then the investigators progressively increased Positive End Expiratory Pressure (PEEP) to have a peak inspiratory pressure (Ppeak) to 45 cm H2O. The whole recruitment maneuver lasts 2 minutes. After the recruitment maneuver the investigators used volume control ventilation again (with the baseline settings)and PEEP step wised decreased to 8 cmH20but. PEEP (8cmH2O) was left until the end of the operation. In the second group the investigators did not used lung recruitment maneuver at all. In both groups lung compliance was measured (dynamic and static)as dv/dp (ml/cmH2O). Measures were assessed 1 minute after delivery (but before recruitment), 3 minutes after recruitment (first group) at 10 and at 20 minutes after recruitment. The investigators also measured Ppeak (cmH2O) and Pplateau (cmH2O)inspiratory pressures , blood pressure (mmHG), beats per minute, oxygen saturation, end-tidal CO2 according to the above time frame, blood Gases before and 3 minutes after recruitment etc.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recruitment Group | Experimental | Procedure: Alveolar Recruitment maneuverThe investigators used alveolar recruitment maneuver by increasing inspiratory pressure to 20 cmH20 and progressively increasing Positive Expiratory Pressure (PEEP) up to 45 cmH2O maximal (Ppeak) inspiratory pressure. The recruitment maneuver lasted 2 minutes. In this group PEEP was set to 8 cmH2O, after the recruitment maneuver, and was left until the end of the operation. |
| Control Group | No intervention | –We did not used alveolar recruitment maneuver |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- general anesthesia,
- hemodynamically stable
Key exclusion criteria (5 listed)
- intracranial hypertension,
- pulmonary hypertension,
- low blood pressure (MBP<80 mmHg),
- Heart rate > 100 beats/min,
- patient refusal
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 |
|---|---|---|
| Alveolar Recruitment maneuverIn this group and during recruitment maneuver the investigators used pressure control ventilation and increased inspiratory time to 50%. The investigators used alveolar recruitment maneuver by increasing inspiratory pressure to 20 cmH20 and progressively increasing Positive Expiratory Pressure (PEEP) up to 45 cmH2O maximal (Ppeak) inspiratory pressure. The recruitment maneuver lasted 2 minutes. After the maneuver PEEP was set to 8 cmH2O and was left until the end of the operation. After the end of the recruitment maneuver volume control ventilation was used until the end of the operation too. | Procedure or surgery | Recruitment Group |
Primary outcome
Lung Compliance change measured as volume difference/pressure difference (dv/dp) or ml/cmH2O is being assessed
Time frame: Before recruitment, 3 minutes after recruitment, 10 minutes after recruitment and 20 minutes after recruitment
3 secondary outcomes
Oxygenation change is being assessed measured as PO2 (mmHg) and O2 Saturation (SPO2)
Time frame: Before recruitment and 20 minutes after recruitment
Gas exchange change is being assessed measured as PCO2 (mmHg) and PH.
Time frame: Before recruitment and at 20 minutes after recruitment
Pulmonary complications
Time frame: up to 72 hours after surgery
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 23 Jun 2015.
- Background: PubMed 20608559Valenza F, Chevallard G, Fossali T, Salice V, Pizzocri M, Gattinoni L. Management of mechanical ventilation during laparoscopic surgery. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):227-41. doi: 10.1016/j.bpa.2010.02.002.
- Background: PubMed 19443420Strang CM, Hachenberg T, Freden F, Hedenstierna G. Development of atelectasis and arterial to end-tidal PCO2-difference in a porcine model of pneumoperitoneum. Br J Anaesth. 2009 Aug;103(2):298-303. doi: 10.1093/bja/aep102. Epub 2009 May 13.
- Background: PubMed 16132894Hedenstierna G, Edmark L. The effects of anesthesia and muscle paralysis on the respiratory system. Intensive Care Med. 2005 Oct;31(10):1327-35. doi: 10.1007/s00134-005-2761-7. Epub 2005 Aug 16.
- Background: PubMed 23196259Cinnella G, Grasso S, Spadaro S, Rauseo M, Mirabella L, Salatto P, De Capraris A, Nappi L, Greco P, Dambrosio M. Effects of recruitment maneuver and positive end-expiratory pressure on respiratory mechanics and transpulmonary pressure during laparoscopic surgery. Anesthesiology. 2013 Jan;118(1):114-22. doi: 10.1097/ALN.0b013e3182746a10.
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.
Diamanto Aretha, MD principal investigator
General Hospital of Pyrgos, Sintriada, Pyrgos, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alveolar Recruitment maneuver in people with Decreased Lung Compliance and Hypoxia, run by General Hospital Of Pyrgos 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 2 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 23 Jun 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Lung Compliance change measured as volume difference/pressure difference (dv/dp) or ml/cmH2O is being assessed (time frame: Before recruitment, 3 minutes after recruitment, 10 minutes after recruitment and 20 minutes after recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01826968, which also lists 4 linked publications.
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 23 Jun 2015; AzTrials last refreshed its copy on 6 Nov 2026.