Alveolar Recruitment Maneuver During Cesarean Section Improves Lung Compliance

NCT01826968 | Completed Phase 2 DMC

• 2 other identifiers: Lung Recruitment in CesareansGHPyrgosRECProt
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Decreased Lung Compliance; Hypoxia; Hypercapnia; Atelectasis; Pneumonia

Keywords

Lung recruitment, cesarean, lung compliance, atelectasis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Oxygenation change is being assessed measured as PO2 (mmHg) and O2 Saturation (SPO2)

  Before recruitment and 20 minutes after recruitment

• Gas exchange change is being assessed measured as PCO2 (mmHg) and PH.

  Before recruitment and at 20 minutes after recruitment

• Pulmonary complications

  up to 72 hours after surgery

Study Arms (2)

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.

Procedure: Alveolar Recruitment maneuver

Control Group

NO INTERVENTION

We did not used alveolar recruitment maneuver

Interventions

Alveolar Recruitment maneuver PROCEDURE

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.

Recruitment Group

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• general anesthesia,
• hemodynamically stable

You may not qualify if:

• intracranial hypertension,
• pulmonary hypertension,
• low blood pressure (MBP\<80 mmHg),
• Heart rate \> 100 beats/min,
• patient refusal

Sponsors & Collaborators

• General Hospital Of Pyrgos: lead

Study Sites (1)

General Hospital of Pyrgos

Pýrgos, Hlia, 27100, Greece

Location

Related Publications (4)

• 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.

  PMID: 20608559 BACKGROUND

• Strang 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.

  PMID: 19443420 BACKGROUND

• Hedenstierna 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.

  PMID: 16132894 BACKGROUND

• 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.

  PMID: 23196259 BACKGROUND

MeSH Terms

Conditions

Hypoxia; Hypercapnia; Pulmonary Atelectasis; Pneumonia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Infections

Study Officials

• Diamanto Aretha, MD

  General Hospital of Pyrgos, Sintriada, Pyrgos, Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Consultant Grade A, MD, Ph.D

Study Record Dates

• First Submitted: March 29, 2013
• First Posted: April 9, 2013
• Study Start: January 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: June 23, 2015

Record last verified: 2013-11

Locations

GR (1)