Contrast ultrasound study to image the circulation in reconstructive head and neck surgery

ISRCTN	ISRCTN94812137
DOI	https://doi.org/10.1186/ISRCTN94812137
Protocol serial number	P0505
Sponsor	Poole Hospital NHS Foundation Trust (UK)
Funder	British Association of Oral and Maxillofacial Surgeons (BAOMS) (UK) - clinical research grant

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Sanjay Sharma
Scientific

Department of Maxillofacial Surgery
Poole Hospital
Longfleet Road
Dorset
Poole
BH15 2JB
United Kingdom

Primary study design	Interventional
Study design	Interventional single-arm open crossover pilot study
Secondary study design	Non randomised controlled trial
Scientific title	A study of power Doppler harmonic imaging in the monitoring of human free-flap tissue perfusion
Study objectives	Contrast harmonic imaging is a superior monitoring method for free flaps compared to standard monitoring.
Ethics approval(s)	Dorset Research Ethics Committee, approved on 04/05/2005 (ref: 05/Q2201/27)
Health condition(s) or problem(s) studied	Free flap reconstruction for head and neck cancer patients
Intervention	Each participant was monitored by both standard procedures and Power Doppler, as follows: Power Doppler contrast enhanced harmonic imaging was carried out at 12, 24 and 48 hours post-surgery. Standard monitoring consisted of the following: clinical observation and hand-held non-imaging spectral Doppler (NISD). Standard monitoring was performed for 14 days par participant.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	1. Qualitative and quantitative analysis of harmonic imaging at 12, 24 and 48 hours post-surgery 2. Time taken for detection of flap failure compared to standard monitoring within 48 hours post-surgery
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	19/05/2007

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	36
Key inclusion criteria	Patients (both males and females) undergoing head and neck surgery requiring free tissue transfer.
Key exclusion criteria	1. Patients under 18 years 2. Pregnancy and lactation 3. Hypersensitivity to SonoVue® 4. Recent coronary syndrome 5. Ischaemic heart disease 6. Cardiovascular compromise
Date of first enrolment	19/05/2005
Date of final enrolment	19/05/2007

Department of Maxillofacial Surgery

Poole
BH15 2JB
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2010		Yes	No