Alveolar Recruitment Maneuver During Cesarean Section Improves Lung Compliance

Pneumonia Clinical Trial

— CSRecGHPyr  

Official title:

Phase 2 Study of the Alveolar Recruitment Maneuver in Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01826968
• Other study ID #: Lung Recruitment in Cesareans
• Secondary ID: GHPyrgosRECProt
• Status: Completed
• Phase: Phase 2
• First received: March 29, 2013
• Last updated: June 22, 2015
• Start date: January 2013
• Est. completion date: March 2014

Study information

• Verified date: November 2013
• Source: General Hospital Of Pyrgos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

Inclusion Criteria:

• general anesthesia,

• hemodynamically stable

Exclusion Criteria:

• intracranial hypertension,

• pulmonary hypertension,

• low blood pressure (MBP<80 mmHg),

• Heart rate > 100 beats/min,

• patient refusal

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atelectasis
• Decreased Lung Compliance
• Hypercapnia
• Hypoxia
• Pneumonia
• Pulmonary Atelectasis

Intervention

Procedure:
• Alveolar Recruitment maneuver
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.

Locations

Country	Name	City	State
Greece	General Hospital of Pyrgos	Pyrgos	Hlia

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital Of Pyrgos

Country where clinical trial is conducted

Greece, 

References & Publications (4)

Cinnella 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. — View Citation

Hedenstierna G, Edmark L. The effects of anesthesia and muscle paralysis on the respiratory system. Intensive Care Med. 2005 Oct;31(10):1327-35. Epub 2005 Aug 16. Review. — View Citation

Strang CM, Hachenberg T, Fredén 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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung Compliance change measured as volume difference/pressure difference (dv/dp) or ml/cmH2O is being assessed		Before recruitment, 3 minutes after recruitment, 10 minutes after recruitment and 20 minutes after recruitment	Yes
Secondary	Oxygenation change is being assessed measured as PO2 (mmHg) and O2 Saturation (SPO2)		Before recruitment and 20 minutes after recruitment	Yes
Secondary	Gas exchange change is being assessed measured as PCO2 (mmHg) and PH.		Before recruitment and at 20 minutes after recruitment	Yes
Secondary	Pulmonary complications		up to 72 hours after surgery	Yes