Centralised Anesthesic Monitoring in the Surgery of the Ocular Anterior Segment: Non Inferiority Study

Ambulatory Surgical Procedures Clinical Trial

— SACHS  

Official title:

Centralised Anesthesic Monitoring in the Surgery of the Ocular Anterior Segment: Non Inferiority Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02037009
• Other study ID #: SC_JMD_2013-1
• Status: Completed
• Phase: N/A
• First received: January 13, 2014
• Last updated: August 5, 2014
• Start date: November 2013
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of HealthFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial Summary

In France, cataract surgery is the most frequent surgical procedure, performed with local anesthesia and most often very light techniques using eye-drops. Technical improvements of surgical and anesthesic procedures have led many countries to implement alternative surveillance procedures. In France, it is mandatory that the persons in charge of anesthetic surveillance (doctors or nurses) should be qualified in anesthesia.

In this study, the investigators aim to assess the feasibility and safety of a centralised monitoring station outside of the operating rooms, as an alternative to the presence of 1 anesthetic nurse in each operating room.

Description:

In their hospital, the investigators will study the following alternatives for the anesthetic surveillance of the 3 operating rooms where surgery of the ocular anterior segment is performed: 1) the usual procedure, with the presence of 3 anesthetic nurses (1 in each operating room) and 2) a new organization with an anesthetic nurse checking a centralised monitoring station and a back-up anesthetic nurse ready to intervene inside the 3 operating rooms whenever needed.

The 2 procedures will be successively implemented during 3 to 4 sequences, until the number of surgical procedures statistically required have been studied.

The investigators aim to demonstrate that the centralised monitored surveillance does not put the patients at risk more often than the current surveillance procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: August 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patient scheduled for ocular anterior segment surgery (cataract, glaucoma, pterygium) with local or topic anesthesia

Exclusion Criteria:

• patient refusing to participate in the study or without health insurance

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Ambulatory Surgical Procedures
• Ocular Anterior Segment Surgery

Intervention

Other:
• Health care organization (anesthetic surveillance)

Locations

Country	Name	City	State
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris	Ile de France

Sponsors (2)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	revision surgery	incidence rate of revision surgery within 24 hours	24 hours after baseline	No
Other	efficiency of the centralised monitoring of anesthesic surveillance	assessment of costs	during surgical procedure	No
Other	patient baseline pain	auto-assessment of patient pain before surgery on a 0 to 10 (maximum pain) scale	baseline	No
Primary	Anesthetic potential impact on surgery conditions	Incidence rate of at least 1 of the following events, during surgery: blood pressure > 200 mmHg on 2 consecutive measures (automatic measure every 3 minutes); cardiac frequency < 45/min for at least 1 mn; SaO2 <85% for at least 1 mn; poor operating conditions (rated = 7 by the surgeon, on a numeric scale from 0 to 10=excellent conditions). Assessment at the exit of operating room.	during surgical procedure	No
Secondary	interventions of the back-up anesthetic nurse	mean number of interventions of the back-up anesthetic nurse during the procedures proportion of surgical procedures requiring at least one intervention of the nurse	during surgical procedure	No
Secondary	patient pre-surgical stress	auto-assessment of stress level using a 0 to 10 (maximum stress) scale	baseline	No
Secondary	pain during surgical procedure	retrospective auto-assessment of patient pain using a 0 to 10 (maximum pain) scale	within 10 minutes after surgery	No
Secondary	patient satisfaction	auto-assessment of patient satisfaction using a 0 to 10 (fully satisfied) scale	within 10 minutes after surgery	No
Secondary	incidence rate of each of the events included in the primary outcome	incidence rate of blood pressure > 200 mmHg on 2 consecutive measures (automatic measure every 3 minutes) incidence rate of cardiac frequency < 45/min for at least 1 mn incidence rate of SaO2 <85% for at least 1 mn incidence rate of poor operating conditions (rated < 7 by the surgeon, on a numeric scale from 0 to 10 (excellent conditions)	during surgical procedure	No
Secondary	patient agitation	assessed by the surgeon using a 0 to 10 (very agitated) scale	within 10 minutes after surgery	No
Secondary	operating conditions	auto-assessment by the surgeon of the operating conditions, on a 0 to 10 (excellent conditions) scale and on a 0 to 10 (completely safe) scale	within 10 minutes after surgery	No
Secondary	working conditions	auto-assessment of working conditions by the anesthetic nurses, on a 0 to 10 (excellent) scale and on a 0 to 10 (completely safe) scale	at the end of a working day	No