Quality of Recovery From Obstetric Anaesthesia - a Multicentre Study

Quality of Life Clinical Trial

— ObsQoR  

Official title:

Quality of Recovery From Obstetric Anaesthesia - a Multicentre Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04192045
• Other study ID #: IRAS254064
• Status: Completed
• Start date: October 11, 2021
• Est. completion date: November 24, 2021

Study information

• Verified date: June 2022
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Quality of recovery is an important outcome measure in anaesthesia, whilst there are validated tools for this in surgery and regional anesthesia there are no fully validated tools for obstetrics anaesthesia. The aim of this study is to use the Obstetric Quality of Recovery (ObsQoR) score across multiple centres to assess correlation to length of stay and variation for different types of operative and non- operative delivery.

Description:

An observational survey based study, for 3 consecutive week days, chosen by the local investigating team during a two-week period across multiple centres.

• Local investigators will complete the survey with each patient who has received anaesthetic intervention from an anaesthetist, 1 day, around 24hrs after delivery in line with their routine anaesthetic follow up.

• At 30 days, a telephone survey will be conducted with each patient to repeat the ObsQoR survey and ask key questions regarding functional recovery and activities of daily living post delivery.

In addition for a small number of sites, elective caesarean delivery patients will have blood taken at the point of anaesthesia and 24 hours post delivery to assess the immune function and any changes which may predict poorer outcome in these women.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1638
• Est. completion date: November 24, 2021
• Est. primary completion date: October 24, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Obstetric patients over 18 years old.

• Intervention occurring after 32/40 gestation.

• All mothers receiving anaesthesia or anaesthetic analgesia during their peripartum period.

Exclusion Criteria:

• Unable to comprehend the questions asked

• Patient refusal

• Under 32/40 weeks gestation

• Cervical cerclage insertion or removal, anaesthesia for External Cephalic Verison

• Neonatal death

• Non- NHS patients

Related Conditions & MeSH terms

• Anesthesia Morbidity
• Obstetric Anesthesia Problems
• Quality of Life

Intervention

Other:
• Survey
A survey will be used at 24 hours and 30 days to assess the quality of recovery

Locations

Country	Name	City	State
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	Stanford University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Correlation of ObsQoR with length of hospital stay (LOS) in hours following delivery across multiple centres, particularly ObsQoR score and prediction of prolonged LOS (>1.5 SD) and readmission to hospital.	During the study the total length of stay in hours will be calculated for participating patients. This will be correlated with the score from the ObsQoR survey tool. In addition the readmission status of the patient will be asked at the subsequent survey combined with the patient's health care record to correlate with the ObsQoR tool score. Where the ObsQoR score is measured between 0-100 and LOS will be in hours. Readmission will be a binary outcome measure	Up to 3 months
Primary	• The relationship between ObsQoR and patient-reported ready for discharge. This will concurrently be determined to account for institutional, non-medical maternal factors neonatal factors that may delay discharge and impact LOS.	The patient will be surveyed using the ObsQoR tool and also asked regarding when they felt they were ready for discharge to take into account the multitude of factors which may impact on the overall length of stay. Where the ObsQoR score is measured between 0-100 and LOS will be in hours.	up to 3 months
Secondary	• Comparing ObsQoR profiles with differing types of obstetric anaesthesia and delivery method.	ObsQoR tool will be used to assess the quality of recovery from General anaesthesia and differing types of regional anaesthesia (Spinal, Epidural, Dural puncture epidural (DPE) and combined spinal and epidural (CSE)	up to 3 months
Secondary	• Variations in ObsQoR scores across differing centres.	A multicentreed evaluation of the ObsQoR score across multiple centres	up to 3 months
Secondary	• Impact of patient factors on ObsQoR score.	A large number of variables will affect the quality of recovery and the ObsQoR score, these factors will be assessed. Where the ObsQoR score is measured between 0-100	up to 3 months
Secondary	• Impact of anaesthetic or obstetric factors on ObsQoR score.	A large number of variables will affect the quality of recovery and the ObsQoR score, these factors will be assessed. Where the ObsQoR score is measured between 0-100	up to 3 months
Secondary	• Impact of neonatal facts on ObsQoR score.	A large number of variables will affect the quality of recovery and the ObsQoR score, these factors will be assessed. Where the ObsQoR score is measured between 0-100	up to 3 months
Secondary	• Impact of institutional factors on ObsQoR score.	Differing centres will have differing institutional setup, guidelines, staffing levels, these will be assessed related to ObsQoR scores. Where the ObsQoR score is measured between 0-100	up to 3 months
Secondary	• Impact of time of day on ObsQoR score.	Time of day may impact on patient care on the quality of recover and the ObsQoR score- these will both be assessed. Where the ObsQoR score is measured between 0-100	up to 3 months
Secondary	• Impact of anaesthesia provider factors on ObsQoR score.	The level of seniority of anaesthesia provider may impact on the quality of recover and the ObsQoR score- these will both be assessed. Where the ObsQoR score is measured between 0-100	up to 3 months
Secondary	• Prediction of patients who are likely to have an ongoing requirement for analgesia.	The varying delivery methods have differing requirements for analgesia, it is not currently known the impact and effect this has on the quality of recovery. Where the ObsQoR score is measured between 0-100	up to 3 months
Secondary	• Prediction of patients who are likely to require further follow up in the community or investigation.	The patient surgical social and institutional demographics which may predispose some patients to seek healthcare in either the community or hospital setting	up to 3 months
Secondary	• Prediction of patients' ability to return to normal activities of daily living.	Functional recovery will be assessed observing return to normal activities of daily living (ADLs) and compared to ObsQoR score for patients of all delivery types. The score of ADLs will be correlated to ObsQoR score Where the ObsQoR score is measured between 0-100	up to 3 months
Secondary	• Prediction of patients' who are unable to achieve adequate activity levels. As determined by number of steps on mobile phone / activity tracker.	Assessment of the number of steps and related to quality of recovery and return to normal activities of daily living. Where steps will be a continuous measure and ObsQoR score will be measured from 0-100.	up to 3 months
Secondary	Assessment of perioperative immune function and response to surgical trauma as a predictor of outcome following elective caesarean delivery.	this will be assessed by taking bloods at the point of anaesthesia and 24 hours post in selected patients undergoing a elective caesarean delivery. The samples will then be analysed to assess the immune response.	up to 3 months
Secondary	Assessment of correlation between ObsQoR scores, EQ-5D and global health visual analogue scale results at 24 hours and 30 days.	Assessment of the relationship between ObsQoR scores at 24 hours with EQ-5D and global VAS scores at 24 hours and 30 days between different patients modes of anaesthesia, delivery types and institutions. Assessment of the relationship patient reported outcome measures PROMs to objective poor recovery such as, length of stay, complications and readmissions	up to 30 days